Addressing Consumer Misconceptions on Antibiotic Use and Resistance in the Context of Sore Throat: Learnings from Social Media Listening.

A misunderstanding of the mechanism of action and bacterial targets of antibiotics by consumers may drive inappropriate antibiotic use and antimicrobial resistance (AMR). Tackling AMR requires an in-depth understanding of consumer beliefs and misconceptions. We explored consumer conversations on a number of social media platforms on antibiotic use and AMR in the context of sore throat and how coronavirus disease 2019 (COVID-19) affected online conversations between 1 January 2018 and 25 November 2021 across eight countries. Five distinct consumer groups were identified (antibiotic-preserving peer educators, antibiotic-cautious consumers, medication-resistant antibiotic opponents, believers in the strength of antibiotics, determined pro-antibiotic consumers) with a wide spectrum of beliefs around antibiotics in sore throat. Many opinions were based upon misconceptions, the most prominent of which was that antibiotics are strong medications that can treat all types of sore throat. COVID-19 had a multifaceted effect on the sore throat and AMR conversation. Sore throat triggered anxiety as consumers feared it may be a COVID-19 symptom while engagement in conversations around antibiotics for COVID-19 increased. Finally, consumers sought multiple routes to access antibiotics, such as directly from the pharmacy or by attempting to persuade physicians to prescribe. Knowledge obtained from this study could be used to develop focused approaches to dispel consumer misconceptions and mitigate AMR.

Evidence of the Efficacy of Flurbiprofen 8.75 mg Lozenges for Patients Receiving Antibiotics for Laboratory-Confirmed Streptococcal Pharyngitis.

OBJECTIVES: To determine the efficacy of flurbiprofen 8.75 mg lozenges for patients with laboratory-confirmed streptococcal pharyngitis both before and concomitant with antibiotics. METHODS: This post hoc analysis comprised adult participants from 2 earlier randomized, double-blind, placebo-controlled studies evaluating the analgesic efficacy of flurbiprofen 8.75 mg lozenges in acute pharyngitis. Throat swabs were obtained to diagnose streptococcal infection. Prior to and 2 hours after each dose of study medication (flurbiprofen or placebo lozenges), patients rated 3 symptoms of acute pharyngitis (sore throat pain, difficulty swallowing, and swollen throat) using visual analogue scales. Appropriate antibiotic treatment was initiated when culture results were reported. Mean changes in each pharyngeal symptom were compared over the immediate 24 hours before and during the initial 24 hours of antibiotic treatment. RESULTS: Twenty-four patients provided both preantibiotic and concomitant antibiotic efficacy outcomes. Relief of throat pain was 93% greater in the flurbiprofen group than in the placebo group before antibiotic coadministration and 84% greater than placebo during antibiotic administration (both P < .05). Relief of difficulty swallowing was 71% greater in the flurbiprofen group than in the placebo before antibiotic administration (P = .16) and 107% greater during concomitant antibiotic administration (P = .04). Relief of the sensation of throat swelling was 295% greater with flurbiprofen than placebo before antibiotic administration (P = .008) and 70% greater during concomitant antibiotic administration (P = .06). For placebo-treated patients, relief from throat pain and difficulty swallowing were similar before and during antibiotic treatment (P > .05), indicating no benefit with antibiotic administration for these symptoms. No treatment-related discontinuations or serious adverse events were reported. CONCLUSIONS: Irrespective of antibiotic use, flurbiprofen 8.75 mg lozenges provide well-tolerated, effective relief of pharyngeal symptoms in patients with streptococcal infection. In the 24 hours after administration, antibiotics provide no relief of throat pain or difficulty swallowing beyond the topical demulcent effects of placebo lozenges.

Efficacy of Triprolidine in the Treatment of Temporary Sleep Disturbance.

Triprolidine, a first-generation antihistamine for allergic rhinitis, has a shorter half-life and fewer persistent effects relative to other antihistamines and may be useful in the treatment of temporary sleep disturbance. Patients aged ≥18 years old were randomized 1:1:1 to receive either triprolidine 2.5 mg (n = 65), triprolidine 5 mg (n = 66), or placebo (n = 67) on 3 consecutive nights. Sleep disturbance index was monitored via wrist actimeter. Subjective measures were assessed via diary card. Triprolidine 2.5 mg had a significantly lower sleep disturbance index versus placebo on night 1 (P = .02); however, when adjusted for outliers, sleep disturbance index did not significantly differ between either dose of triprolidine versus placebo on night 1. Adjusted sleep disturbance index was significantly lower with triprolidine 2.5 and 5 mg versus placebo on night 3 (P = .0017 and P = .011, respectively) and for the mean of all 3 nights (P = .01 and P = .015, respectively). Sleep latency was significantly improved for triprolidine 2.5 mg versus placebo on nights 2 and 3 and for the mean of all 3 nights and for triprolidine 5 mg versus placebo for the mean of all 3 nights. Subjective measures showed those on both doses of triprolidine felt more refreshed on awakening versus placebo for the mean of all 3 nights, with no increase in daytime sleepiness. The frequency of adverse events was similar across groups. The optimum dose of triprolidine for treatment of temporary sleep disturbance was 2.5 mg. There were improvements in both objective and subjective measures of sleep quality versus placebo, with no safety concerns raised.

Point-of-Care Testing for Pharyngitis in the Pharmacy.

Pharyngitis (also known as sore throat) is a common, predominately viral, self-limiting condition which can be symptomatically managed without antibiotic treatment. Inappropriate antibiotic use for pharyngitis contributes to the development and spread of antibiotic resistance. However, a small proportion of sore throats caused by group A streptococcal (GAS) infection may benefit from the provision of antibiotics. Establishing the cause of infection is therefore an important step in effective antibiotic stewardship. Point-of-care (POC) tests, where results are available within minutes, can distinguish between viral and GAS pharyngitis and can therefore guide treatment in primary healthcare settings such as community pharmacies, which are often the first point of contact with the healthcare system. In this opinion article, the evidence for the use of POC testing in the community pharmacy has been discussed. Evidence suggests that pharmacy POC testing can promote appropriate antibiotic use and reduce the need for general practitioner consultations. Challenges to implementation include cost, training and 'who prescribes', with country and regional differences presenting a particular issue. Despite these challenges, POC testing for pharyngitis has become widely available in pharmacies in some countries and may represent a strategy to contain antibiotic resistance and contribute to antimicrobial stewardship.

Inhibition of viral and bacterial trigger-stimulated prostaglandin E2 by a throat lozenge containing flurbiprofen: An in vitro study using a human respiratory epithelial cell line.

OBJECTIVES: Symptoms of sore throat result from oropharyngeal inflammation, for which prostaglandin E2 is a key mediator. Flurbiprofen is a non-steroidal anti-inflammatory that provides sore throat relief. The preliminary objective of this study was to develop an in vitro model for assessing prostaglandin E2 stimulation by viral and bacterial triggers. The primary objective was to investigate the effect of diluted flurbiprofen-containing lozenges on prostaglandin E2 concentrations in stimulated cells. METHODS: Prostaglandin E2 production was stimulated in three epithelial cell lines (A549, HEp2, and clonetics bronchial/tracheal epithelial) with influenza A virus (4.5 log10 tissue culture infectious dose50/mL), or bacterial lipopolysaccharide (10µ g/mL) and peptidoglycan (3µ g/mL) and incubated overnight. Prostaglandin E2 levels were assessed by enzyme-linked immunosorbent assay up to 24 h after stimulation. The effect of flurbiprofen 8.75 mg lozenges (diluted to 0.44 mg/mL) on PGE2 production in stimulated cells was assessed in parallel; prior to viral/LPS/PEP stimulation of cells, 300 µL of test product or control was added and incubated for 30 s, 2 and 5 min (and 10 min for bacterial trigger). Prostaglandin E2 levels were measured following stimulation. RESULTS: Viral and lipopolysaccharide/peptidoglycan infection did not consistently stimulate HEp2 cells and bronchial/tracheal epithelial cells to produce prostaglandin E2. Influenza virus, and lipopolysaccharide/peptidoglycan stimulated high prostaglandin E2 concentrations in A549: mean prostaglandin E2 concentration 106.48 pg/mL with viral stimulation vs 33.82 pg/mL for uninfected cells; 83.84 pg/mL with lipopolysaccharide/peptidoglycan vs 71.96 pg/mL for uninfected cells. Flurbiprofen produced significant reductions in virus-stimulated prostaglandin E2 vs stimulated untreated cells at 2 min (p = 0.03). Flurbiprofen produced significant reductions in lipopolysaccharide/peptidoglycan-stimulated prostaglandin E2 concentrations from 30 s (p = 0.02), and at 2, 5 and 10 min (all p < 0.005) vs stimulated untreated cells. CONCLUSIONS: A549 cells provide a suitable model for assessment of prostaglandin E2 stimulation by viral and bacterial triggers. Diluted flurbiprofen-containing lozenges demonstrated rapid anti-inflammatory activity in viral- and lipopolysaccharide/peptidoglycan-stimulated A549 cells.

Patients with Sore Throat: A Survey of Self-Management and Healthcare-Seeking Behavior in 13 Countries Worldwide.

BACKGROUND: Acute sore throat is one of the most common problems for which patients consult their general practitioner and is a key area for inappropriate antibiotic prescribing. The objective of this study was to investigate patients' attitudes related to healthcare-seeking behavior and self-management of sore throat. METHODS: We conducted an observational, questionnaire-based study across 13 countries (Australia, Brazil, China, France, Germany, Italy, the Philippines, Russia, Saudi Arabia, South Africa, Thailand, the UK and the USA) on respondents who reported having had a sore throat in the previous 12 months. Data were collected on their experiences, contact with healthcare professionals, treatment practices and opinions about antibiotics. RESULTS: A total of 5196 respondents (approximately 400 per country) completed the survey. Over 80% of respondents sought advice for a sore throat, with 30% consulting a general practitioner. The desire to limit the worsening of symptoms was the main reason for seeking treatment. Other reasons concerned resolving persistent symptoms and reducing the impact on daily life/sleep. Self-management for sore throat was mainly medicated sore throat remedies. "Wanting an antibiotic" was rated much lower (55%) than most other reasons for visiting a doctor, but this differed greatly between countries. The percentage of respondents using antibiotics varied widely, for example, 10% in the UK and 45% in Saudi Arabia. There was considerable variation in the proportion of respondents who thought that antibiotics would be effective against sore throat (from 24% in France to 94% in Saudi Arabia). CONCLUSIONS: Our findings suggest that knowledge of effective treatments for sore throat varied widely. The results of this study should enable healthcare professionals to better anticipate patients' needs. This will support healthcare professionals in their role as antibiotic stewards, helping to reduce the misuse of antibiotics, and further guiding patients towards symptomatic self-management of sore throat.

Refinement and further application of the Qualities of Sore Throat Index (QuaSTI).

Aim: The Qualities of Sore Throat Index (QuaSTI) assesses the status of patient-reported pharyngeal pain. One study used QuaSTI in isolation; a separate study used QuaSTI plus the Sore Throat Scale (STS). Both studies also used a Sore Throat Pain Intensity Scale (STPIS). This study evaluates STS and STPIS as instruments to refine the QuaSTI. Materials & methods: Correlational analysis determined the degree of association between STPIS and STS. Confirmatory factor analyses evaluated the proposed factor structure of QuaSTI. Results: A strong correlation between STS and STPIS (r = 0.91; p < 0.01), supports the use of STS in QuaSTI. Analyses confirm a three-factor structure for the 10-item QuaSTI and validate inclusion of an additional item to create an 11-item tool for measuring pharyngeal pain. Conclusion: The QuaSTI represents a robust and validated tool for measuring therapeutic effects in patients with pharyngitis.

Bactericidal activity of hexylresorcinol lozenges against oropharyngeal organisms associated with acute sore throat.

OBJECTIVE: For the majority of people with acute sore throat, over-the-counter treatments represent the primary option for symptomatic relief. This study evaluated the in vitro bactericidal activity of lozenges containing the antiseptic hexylresorcinol against five bacteria associated with acute sore throat: Staphylococcus aureus, Streptococcus pyogenes, Moraxella catarrhalis, Haemophilus influenzae and Fusobacterium necrophorum. RESULTS: Hexylresorcinol 2.4 mg lozenges were dissolved into 5 mL of artificial saliva medium. Inoculum cultures were prepared in triplicate for each test organism to give an approximate population of 108 colony-forming units (cfu)/mL. Bactericidal activity was measured by log reduction in cfu. Greater than 3log10 reductions in cfu were observed at 1 min after dissolved hexylresorcinol lozenges were added to S. aureus (log10 reduction cfu/mL ± standard deviation, 3.3 ± 0.2), M. catarrhalis (4.7 ± 0.4), H. influenzae (5.8 ± 0.4) and F. necrophorum (4.5 ± 0.2) and by 5 min for S. pyogenes (4.3 ± 0.4). Hexylresorcinol lozenges achieved a > 99.9% reduction in cfu against all tested organisms within 5 min, which is consistent with the duration for a lozenge to dissolve in the mouth. In conclusion, in vitro data indicate that hexylresorcinol lozenges offer rapid bactericidal activity against organisms implicated in acute sore throat.

Topical (local) antibiotics for respiratory infections with sore throat: An antibiotic stewardship perspective.

WHAT IS KNOWN AND OBJECTIVE: The overuse and misuse of antibiotics, especially for viral, and self-limiting, respiratory tract infections such as sore throat, increases the risk of the development and spread of antimicrobial resistance within communities. Up to 80% of sore throat cases have a viral aetiology, and even when the infection is bacterial, most cases resolve without antibiotics. However, antibiotics are still frequently and often inappropriately prescribed for the treatment of sore throat. Furthermore, topical (local) antibiotics for treatment of sore throat are widely available over the counter. The objective of this systematic review was to establish the evidence for the benefits, risk of harm and antimicrobial resistance associated with topical (local) antibiotics used for patients with sore throat. METHODS: Eligible studies included those in patients with sore throat of any aetiology receiving the topical (local) antibiotics tyrothricin, bacitracin, gramicidin or neomycin where the antibiotic was topically/locally applied via the nasal cavity or throat. Nasal applications were included as these are occasionally used to treat upper respiratory tract infections that may involve sore throat. There was no restriction or requirement regarding comparator. The outcomes of interest included efficacy, safety, and in vitro culture and antimicrobial resistance data. RESULTS AND DISCUSSION: This systematic review found sparse and mainly poor-quality evidence relating to the use of topical (local) antibiotics for sore throat, and it was not possible to establish the benefits, risk of harm or impact of use on antimicrobial resistance. WHAT IS NEW AND CONCLUSIONS: Further research is necessary to ascertain the risks and benefits of topical (local) antibiotics, their contribution to antimicrobial resistance and the risk of harm. We do, however, question whether it is appropriate and rational to use topical (local) antibiotics for the treatment of sore throat caused by respiratory tract infections in the absence of robust evidence.

Locally Delivered Flurbiprofen 8.75 mg for Treatment and Prevention of Sore Throat: A Narrative Review of Clinical Studies.

BACKGROUND: Antibiotics are inappropriately prescribed to many people with sore throat. As most cases of sore throat are viral and/or self-limiting, guidelines recommend symptomatic management as first-line treatment. This paper reviews the available clinical evidence for the efficacy and safety of low-dose (8.75 mg) flurbiprofen, locally delivered to the throat for the symptomatic management of pharyngitis/sore throat. METHOD: A literature search was performed on 27 February 2019 using PubMed. Studies that met the following criteria were included in a narrative review: (1) studies evaluating the effectiveness of flurbiprofen for pharyngitis/sore throat; (2) randomized controlled studies; (3) locally administered formulation of study drug/comparator; and (4) flurbiprofen administered at 8.75 mg dose (single- or multiple-dose administration). RESULTS: A total of 17 papers were included in the review: 15 publications reporting data from nine unique clinical studies of flurbiprofen for acute pharyngitis, and two reporting studies of flurbiprofen for the prevention of postoperative sore throat (POST). Studies in acute pharyngitis demonstrated that single- and multiple-dose flurbiprofen 8.75 mg, locally administered in lozenge, spray or microgranule form, was well tolerated and provided early onset and long-lasting symptomatic relief from throat pain and soreness, sensation of swollen throat, difficulty swallowing, and other associated symptoms. This included patients with more severe symptoms, patients with confirmed Streptococcus A/C sore throat, and patients taking concomitant antibiotics. In addition, a single preoperative dose of flurbiprofen lozenge was shown to be effective for relieving early POST in patients undergoing general anesthesia. CONCLUSION: Locally administered, low-dose flurbiprofen offers a useful first-line treatment option for symptomatic relief in patients with "uncomplicated" acute pharyngitis/sore throat associated with upper respiratory tract infection, thus potentially helping to reduce unnecessary antibiotic prescribing. It also offers an effective preoperative treatment option for the reduction of early POST severity and incidence.

Spectrum of bactericidal action of amylmetacresol/2,4-dichlorobenzyl alcohol lozenges against oropharyngeal organisms implicated in pharyngitis.

PURPOSE: Pharyngitis is commonly caused by a self-limiting upper respiratory tract infection (URTI) and symptoms typically include sore throat. Antibiotics are often inappropriately used for the treatment of pharyngitis, which can contribute to antimicrobial resistance, therefore non-antibiotic treatments which have broad antiseptic effects may be more appropriate. Amylmetacresol (AMC) and 2,4-dichlorobenzyl alcohol (DCBA) are present in some antiseptic lozenges and have established benefits in providing symptomatic relief and some in vitro antiviral action. METHODS: Seven bacterial species associated with pharyngitis, namely Streptococcus pyogenes, Fusobacterium necrophorum, Streptococcus dysgalactiae subspecies equisimilis, Moraxella catarrhalis, Haemophilus influenza, Arcanobacterium haemolyticum and Staphylococcus aureus, were exposed to an AMC/DCBA lozenge dissolved in artificial saliva. In vitro bactericidal activity was measured as a log reduction in colony-forming units (CFUs). RESULTS: Bactericidal activity was recorded against all organisms after 1 minute. Greater than 3 log10 reductions in CFUs were observed at 1 minute for S. pyogenes (log10 reduction CFU/mL ± SD, 5.7±0.1), H. influenza (6.1±0.1), A. haemolyticum (6.5±0.0) and F. necrophorum (6.5±0.0), at 5 minutes for S. dysgalactiae (6.3±0.0) and M. catarrhalis (5.0±0.9) and at 10 minutes for S. aureus (3.5±0.1). CONCLUSION: An AMC/DCBA lozenge demonstrated a greater than 99.9% reduction in CFUs against all tested species within 10 minutes, which is consistent with the time a lozenge remains in the mouth. Patients with uncomplicated bacterial pharyngitis may benefit from the antibacterial action of antiseptic AMC/DCBA lozenges. Furthermore, AMC/DCBA lozenges may be more relevant and appropriate than antibiotics for pharyngitis associated with a self-limiting viral URTI.

Onset of analgesia by a topically administered flurbiprofen lozenge: a randomised controlled trial using the double stopwatch method.

BACKGROUND: The double stopwatch (DSW) method for determining the onset of analgesic activity has been implemented extensively by investigators studying orally administered drugs. OBJECTIVE: The aim of this randomised, placebo-controlled trial was to use the DSW method to determine the time to onset of analgesia of a single dose of a topically administered non-steroidal anti-inflammatory drug, flurbiprofen 8.75 mg lozenge. METHODS: Adults with acute sore throat (n = 122) were examined to confirm the presence of tonsillopharyngitis (Tonsillo-Pharyngitis Assessment) and sore throat pain of at least moderate intensity (≥6 on a 0-10 Sore Throat Scale). Lozenges containing flurbiprofen 8.75 mg or inert ingredients (identically flavoured) were administered under double-blind conditions in the clinic while patients assessed pain and pain relief over 3 hours. Onset of analgesia was determined using the DSW method and reported as the Kaplan-Meier median time to meaningful relief. The median time to first perceived relief was also documented. RESULTS: About 78% of flurbiprofen-treated patients reported meaningful pain relief compared with 48% of placebo-treated patients (p < 0.01); median time to meaningful relief for flurbiprofen-treated patients was 43 minutes (placebo-treated patients were right-censored due to non-responsivity; p = 0.01). Median time to first perceived pain relief was 11 minutes for flurbiprofen-treated patients and 19 minutes for placebo-treated patients (p = 0.03). Flurbiprofen lozenge was well tolerated, with no serious adverse events occurring and no patient discontinuing due to an adverse event. CONCLUSION: These results indicate that the DSW method can be successfully applied to the evaluation of the onset of action of a locally administered analgesic in patients with acute sore throat, demonstrating that the onset of action (time to meaningful pain relief) of flurbiprofen lozenge was <45 minutes.

Improvements in throat function and qualities of sore throat from locally applied flurbiprofen 8.75 mg in spray or lozenge format: findings from a randomized trial of patients with upper respiratory tract infection in the Russian Federation.

OBJECTIVE: To assess the speed of relief provided by flurbiprofen 8.75 mg spray and lozenge and their effect on many of the different qualities and characteristics of throat pain and discomfort, and the many articulations of the broad term "sore throat" (ST). PATIENTS AND METHODS: Four hundred and forty adults with recent-onset, moderate-to-severe ST due to upper respiratory tract infection (URTI) were randomized to a single dose of either flurbiprofen 8.75 mg spray (n=218) or flurbiprofen 8.75 mg lozenge (n=222). Throat swabs for bacterial culture were taken at baseline. ST relief was assessed at 1 minute, 1 and 2 hours post-dose using the Sore Throat Relief Rating Scale. The change from baseline at 1 and 2 hours post-dose in difficulty swallowing and swollen throat was assessed using the difficulty swallowing scale and the swollen throat scale, respectively. Patients' experience of URTI symptoms was assessed using a URTI questionnaire at baseline and 2 hours post-dose. The change in Qualities of Sore Throat Index, a 10-item index of qualities of ST, from baseline at 2 hours post-dose was also measured. RESULTS: ST relief was evident in the spray and the lozenge treatment groups at 1 minute, 1 and 2 hours post-dose (P>0.05). In both groups, scores for difficulty swallowing and swollen throat significantly improved at 1 and 2 hours post-dose compared with baseline. At 2 hours post-dose, the number of patients experiencing URTI symptoms that can be attributed to or associated with ST decreased relative to baseline. The mean change from baseline to 2 hours post-dose for each individual score on the Qualities of Sore Throat Index showed significant improvements for flurbiprofen spray and lozenge (all P<0.0001). CONCLUSION: Non-inferiority was established, and flurbiprofen spray and lozenge provided effective relief from ST pain and many of the other commonly reported qualities of ST.

Meaningful relief with flurbiprofen 8.75 mg spray in patients with sore throat due to upper respiratory tract infection.

AIM: Evaluate the efficacy of flurbiprofen 8.75 mg spray for sore throat relief. PATIENTS & METHODS: Randomized, double-blind study in adults with sore throat due to upper respiratory tract infection who took flurbiprofen (n = 249) or placebo spray (n = 256). Pain relief was assessed using the Sore Throat Relief Rating Scale. RESULTS: Flurbiprofen spray provided significantly greater relief versus placebo from 20 min to 6 h (p < 0.0001; maximum difference: 75 min). Sore throat severity was reduced ≥-2.2 on the Sore Throat Scale from 75 min to 6 h, indicating meaningful relief. Significantly more patients taking flurbiprofen spray reported ≥30 min of 'at least moderate' relief versus placebo over 6 h (p < 0.0001). Most adverse events were mild. CONCLUSION: Flurbiprofen spray provides rapid, long-lasting and clinically meaningful relief from sore throat (ANZCTR: ACTRN12612000457842).

Qualities of Sore Throat Index (QuaSTI): measuring descriptors of sore throat in a randomized, placebo-controlled trial.

AIM: Patients with pharyngitis often describe various sensory, affective and evaluative pain qualities. Using an 11-word/phrase index, the Qualities of Sore Throat Index (QuaSTI), we characterized throat symptoms and evaluated changes in a randomized controlled trial (NCT01986361). MATERIALS & METHODS: Patients received a single flurbiprofen 8.75 mg (n = 101) or placebo (n = 21) lozenge and rated throat soreness at baseline and regular intervals over 3 h, and the QuaSTI at baseline, 1, 2 and 3 h post-treatment. RESULTS: The QuaSTI distinguished active drug from placebo and detected clinically important (≥2-point) changes over 3 h. Mean change from baseline over 3 h was significantly greater for flurbiprofen (154%) than placebo (p < 0.05). CONCLUSION: The QuaSTI is a sensitive instrument for measuring therapeutic effects in patients with pharyngitis.

Comparison of the Characteristics and Performance of Flurbiprofen 8.75 mg Spray for Sore Throat.

BACKGROUND: Sore throat sprays provide targeted relief by delivering the active ingredient directly to the site of pain. Different sprays vary in characteristics, thus affecting delivery of the active ingredient to the throat, which can impact compliance. OBJECTIVE: The characteristics and performance of FLURBIPROFEN 8.75 mg SPRAY were compared with 12 other sprays. METHOD: Parameters assessed included spray angle and pattern, droplet size distribution, shot weight uniformity and shot weight throughout life. RESULTS: Among all sprays tested WICK Sulagil Halsspray had the smallest spray angle (46°) and also the smallest diameter spray pattern (X=32.8 mm; Y=34.4 mm). Thiovalone® Buccal Spray Suspension had both the largest spray angle (82°) and largest diameter spray pattern (X=62.6 mm; Y=78.0 mm). Hasco Sept® Aerosol Spray had the smallest droplet size (Dv90=118.4 µm) whereas OKi infiammazione e dolore® 0.16% spray had the largest (Dv90=214.34 µm). In terms of shot weight uniformity, TANTUM® VERDE GOLA 0.25% spray showed the least variation (2% RSD) between shots and UNIBEN Aerosol Spray the most (23.4% RSD). Shot weight throughout life studies showed that FLURBIPROFEN 8.75 mg SPRAY had the least deviation from shot weight (1.77%) whereas OKi infiammazione e dolore® 0.16% spray deviated the most (44.9%). FLURBIPROFEN 8.75 mg SPRAY had the second smallest spray angle/pattern and droplet size distribution and also the least variation in shot weight. CONCLUSION: Different sore throat sprays vary in different attributes, affecting delivery of the active ingredient. FLURBIPROFEN 8.75 mg SPRAY performed well overall, ranking first among all sprays tested, and providing a dose which is targeted and uniformly delivered throughout the life of the bottle.

Flurbiprofen 8.75 mg lozenges for treating sore throat symptoms: a randomized, double-blind, placebo-controlled study.

AIM: This study assessed multiple doses of flurbiprofen 8.75 mg lozenges for the relief of three prominent symptoms of acute pharyngitis: pain intensity (primary end point), difficulty swallowing and swollen throat. PATIENTS & METHODS: A total of 204 patients (102 in each group) with confirmed pharyngitis (onset ≤4 days) were randomly assigned to take up to five flurbiprofen or placebo lozenges every 3-6 h, for 7 days. Using validated rating scales (sore throat pain intensity, difficulty swallowing and swollen throat) patients rated their symptoms for the duration of the study. RESULTS: Over the first 24 h, patients treated with flurbiprofen lozenges reported significantly greater reductions in sore throat pain (47%) as well as difficulty swallowing (66%) and swollen throat (40%) compared with placebo (all p < 0.05). CONCLUSION: Multiple doses of flurbiprofen lozenges provide effective relief of sore throat pain intensity as well as difficulty swallowing and swollen throat.

Efficacy of flurbiprofen 8.75 mg lozenge in patients with a swollen and inflamed sore throat.

OBJECTIVE: Sore throat is often over-treated with antibiotics, therefore there is a need for non-antibiotic treatments that provide effective relief. From the patient's point of view, symptoms of pharyngeal inflammation such as a "swollen" and "inflamed" throat are often considered the most bothersome; so, a non-steroidal anti-inflammatory drug could be an appropriate treatment. We investigated the efficacy and safety of flurbiprofen 8.75 mg lozenge in adults with a swollen and inflamed throat. RESEARCH DESIGN AND METHODS: We enrolled adults with moderate-to-severe sore throat and evidence of tonsillo-pharyngitis into a randomized, double-blind study. Patients received flurbiprofen 8.75 mg or placebo lozenges every 3-6 hours as needed (up to five lozenges in 24 hours) and rated their symptoms (sore throat pain, difficulty swallowing and the sensation of a swollen throat) on standard linear scales regularly over 24 hours. The efficacy of flurbiprofen lozenge was determined in patients reporting a swollen and inflamed throat at baseline, as well as those with relatively severe symptoms. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01049334. MAIN OUTCOME MEASURES: The main outcome measures were the time-weighted summed differences in patient-reported sore throat pain, difficulty swallowing and swollen throat over 24 hours. RESULTS: Out of 204 patients, 124 (60.8%) described their throats as swollen and inflamed at baseline. Flurbiprofen lozenges provided greater relief than placebo over 24 hours: 79.8%, 99.6% and 69.3% (for sore throat pain, difficulty swallowing and swollen throat, respectively, all P ≤ 0.01). These outcomes were more substantial in patients with relatively severe symptoms. No serious or unexpected adverse events occurred. CONCLUSIONS: Flurbiprofen 8.75 mg lozenge appears to provide effective, well-tolerated relief of sore throat, difficulty swallowing and swollen throat in adults with a swollen and inflamed throat, as well as those with relatively severe symptoms. A limitation of these findings is that, while predetermined, these are secondary outcomes derived from a targeted sub-group of patients, not the entire study population.

Efficacy of flurbiprofen 8.75 mg spray in patients with sore throat due to an upper respiratory tract infection: A randomised controlled trial.

BACKGROUND: Viral infections cause most cases of pharyngitis (sore throat); consequently, antibiotics are generally not warranted. However, a treatment targeting pain and inflammation, e.g. a topical non-steroidal anti-inflammatory spray, may be helpful for patients. OBJECTIVE: To evaluate the efficacy and safety of flurbiprofen 8.75 mg spray. METHODS: This randomised, double-blind, parallel group study was conducted at six community-based clinical research centres in Australia and two in New Zealand. Adults with sore throat due to upper respiratory tract infection (onset ≤ four days) took one dose of flurbiprofen (n = 249) or placebo spray (n = 256); after six hours, they could re-dose every three-six hours as required, for three days (max. five doses/day). The primary endpoint was the area under the change from baseline curve in throat soreness from zero-two hours (AUC0-2h). The change from baseline in other sore throat symptoms also assessed efficacy. RESULTS: The mean AUC0-2h for throat soreness was significantly greater with flurbiprofen spray (-1.82; 95% CI: -1.98 to 1.65) compared with placebo (-1.13; 95% CI: -1.27 to 0.99) (P < 0.0001). Significantly greater reductions from baseline were observed with flurbiprofen spray compared with placebo from the first time-points assessed (five minutes for throat soreness/difficulty swallowing, 20 minutes for sore throat pain intensity and 30 minutes for swollen throat) for up to six hours (P < 0.05 for all). There was no significant difference in adverse events between treatment groups during the three-day study. CONCLUSION: Flurbiprofen spray provides rapid and long-lasting relief from sore throat symptoms, and is well-tolerated over three days.