Safety and Pharmacokinetics of PSD502 in Healthy Chinese Male and Female Volunteers: Two Randomized, Double-Blind, Placebo-Controlled, Phase I Trials.

BACKGROUND AND OBJECTIVE: PSD502 is a metered-dose spray for premature ejaculation. The two trials aimed to evaluate the safety and pharmacokinetics of PSD502 in healthy Chinese male and female individuals. METHODS: Two phase I, randomized, double-blind, placebo-controlled trials were conducted in men (Trial 1) and women (Trial 2). The participants were randomized 3:1 to receive PSD502 (7.5 mg of lidocaine and 2.5 mg of prilocaine per spray) or a placebo. For male individuals, a single dose (three sprays) once daily was applied to the glans penis for 21 days except for nine sprays (three doses) on days 7 and 14, 4 h apart for each dose. For female individuals, two sprays were applied to the vagina and one to the cervix once daily for 7 days. The primary endpoint was safety. Pharmacokinetics analysis was also performed. RESULTS: Twenty-four male and 24 female individuals were recruited. Treatment-emergent adverse events occurred in 38.9% (7/18) of male individuals and 66.7% (12/18) of female individuals in the PSD502 group, respectively. Both trials reported 50.0% (3/6) treatment-emergent adverse events for the placebo. No grade ≥ 3 treatment-emergent adverse events, serious adverse events, or treatment-emergent adverse events leading to early withdrawal or discontinuation occurred. After consecutive applications, lidocaine and prilocaine cleared rapidly in both trials. Plasma concentrations exhibited high inter-individual variability. The maximum plasma concentrations of active ingredients were far below the anticipated minimum toxic concentrations. The area under the plasma concentration-time curve of metabolites were ≤ 20% of the parent drugs. No clinically significant accumulations were observed in the two trials. CONCLUSIONS: PSD502 was well tolerated and showed low plasma concentrations in healthy Chinese male and female individuals.

[Recommendations for the treatment of premature ejaculation]. / Recommandations pour le traitement de l'éjaculation prématurée.

OBJECTIVES: The Post-University Interdisciplinary Association of Sexology (AIUS) has brought together a panel of experts to develop French recommendations for the management of premature ejaculation. METHODS: Systematic review of the literature between 01/1995 and 02/2022. Use of the clinical practice guidelines (CPR) method. RESULTS: We recommend giving all patients with PE psychosexological counseling, and whenever possible combining pharmacotherapies and sexually-focused cognitive-behavioral therapies, involving the partner in the treatment process. Other sexological approaches could be useful. We recommend the use of dapoxetine as first-line, on-demand oral therapy for primary and acquired PE. We recommend the use of lidocaine 150mg/mL/prilocaine 50mg/mL spray as local treatment for primary PE. We suggest the combination of dapoxetine and lidocaine/prilocaine in patients insufficiently improved by monotherapy. In patients who have not responded to treatments with marketing authorisation, we suggest using an off-label SSRI, preferably paroxetine, in the absence of a contraindication. We recommend treating ED before PE in patients with both symptoms. We do not recommend using α-1 blockers or tramadol in patients with PE. We do not recommend routine posthectomy or penile frenulum surgery for PE. CONCLUSION: These recommendations should contribute to improving the management of PE.

Effect of 5% EMLA Cream on Postoperative Sore Throat in Adults Following General Endotracheal Anesthesia: A Randomized Placebo-Controlled Study.

BACKGROUND: Postoperative sore throat (POST) is a distressing complaint in adults after endotracheal intubation. This study aimed to evaluate the effect of topical application of a eutectic mixture of local anesthetics (EMLA) cream over the endotracheal tube (ETT) cuff on the incidence and severity of POST, cough, and hoarseness of voice in adults after surgery. METHODS: In this randomized, placebo-controlled study, adult patients 18 to 65 years old, in American Society of Anesthesiologists (ASA) physical status I and II, and of either sex were scheduled to receive 5% EMLA cream (intervention arm) or lubricant gel (placebo-controlled arm) applied over the ETT cuff. POST was graded as none (0), mild (1), moderate (2), or severe (3). A score of ≥2 was considered as significant POST. The incidence of POST at the sixth postoperative hour was the primary outcome. Secondary outcomes included the incidence of POST at 0, second, and 24 hours, and the incidence of significant POST (score ≥2). The incidence and severity of postoperative cough and hoarseness of voice were recorded simultaneously. RESULTS: Two hundred and four patients completed the study. The incidence of POST was significantly lower in the EMLA group versus placebo at the sixth postoperative hour (4.9% vs 40.1%; relative risk [RR], 0.12; 95% confidence interval [CI], 0.05-0.29; P < .001); and at 0 hour (74.5% vs 93.1%; RR, 0.8; 95% CI, 0.7-0.9; P < .001) and second hour (51.9% vs 84.3%; RR, 0.61; 95% CI, 0.5-0.75; P < .001) but comparable at 24 hours (1.9% vs 3.9%; RR, 0.5; 95% CI, 0.09-2.67; P = .4). The number needed to treat to prevent POST with EMLA cream application was 5 at 0 hour and 3 at the second and sixth hour. The proportion of patients with significant POST over 24 hours were less in the EMLA group (9.8% vs 43.1%; P < .001). The incidence of postoperative cough and hoarseness of voice was significantly less at the 0, second, and sixth hours in the EMLA group, but comparable at 24 hours. The incidence of severe cough (8.8% vs 31.4%; P < .001) and hoarseness of voice (2% vs 7.4%; P < .001) over 24 hours was less in the EMLA group. CONCLUSIONS: The application of EMLA cream over ETT cuff reduces the incidence and severity of POST, cough, and hoarseness of voice in adults after general anesthesia in the early postoperative period compared to lubricant gel.

Real-life use of the eutectic mixture lidocaine/prilocaine spray in men with premature ejaculation.

Topical anaesthetics are considered a first-line therapy option in men with premature ejaculation (PE). A cross-sectional retrospective analysis was performed to evaluate the real-life use of the eutectic mixture of prilocaine/lidocaine spray (FORTACIN™) in a cohort of 198 white-European men who had been consecutively and prospectively seen at a single tertiary-referral andrology centre for self-reported PE and naive for previous PE treatments. Descriptive statistics was used to describe the whole cohort and the paired t-test was applied to investigate potential differences throughout a 12-month follow-up (baseline, 1, 3, 6 and 12 months). Overall, mean (SD) age was 37 (6.5) years. Of all, lifelong, acquired and subjective PE were reported in 101 (51%), 59 (29.8%) and 38 (19.2%) patients at baseline, respectively. FORTACIN™ use increased up to 6 months, with 184 (92.9%) and 128 (66.4%) men who had tried and regularly used the compound, respectively. At 12-month follow-up, 53 (26.8%) men reported a regular use of the compound. Mean Premature Ejaculation Diagnostic Tool score significantly decreased at 6 and 12 months compared to baseline (all p < 0.05). Conversely, mean IELT significantly improved at 6-month follow-up compared to baseline (all p ≤ 0.04). Overall, FORTACIN™ emerged to be a safe and effective treatment option in PE patients of various types, with almost one fourth of patients still under treatment after 12 months. Timing and dosing of the drug can deserve to be adjusted according to patient's needs and their sexual ecology.

Histopathology after lidocaine/prilocaine cream administration for vulvar biopsy.

BACKGROUND: Case series have described disruptive histopathologic changes following lidocaine/prilocaine cream anesthetic for biopsies. METHODS: A study of histopathologic changes was performed following a randomized trial comparing topical lidocaine/prilocaine cream to 1% lidocaine injection anesthesia for vulvar biopsy. Histopathology was reviewed by two independent dermatopathologists blinded to the type of anesthetic. Specimens were scored on six histopathologic criteria described in the literature. Individual scores for each histopathologic feature and the total score across features were compared between the two groups using marginal models with generalized estimating equations. RESULTS: Of 37 specimens reviewed, 19 were randomized to lidocaine/prilocaine cream and 18 to 1% lidocaine. Subjects exposed to lidocaine/prilocaine had the following odds of histopathologic changes, relative to lidocaine-exposed subjects: acantholysis (odds ratio 2.48; 95% confidence intervals [CI] 0.51, 12.06), clefting (2.42; 0.64, 9.14), pallor/necrosis (1.13; 0.28, 4.50), spongiosis (0.71; 0.18, 2.85), and papillary dermal edema (1.17; 0.41, 3.29). Total scores were not significantly different between treatment arms (risk ratio 0.98; 0.71, 1.35). CONCLUSION: This histopathologic analysis of a randomized trial between lidocaine/prilocaine cream and injected lidocaine as anesthesia for vulvar biopsy shows the absence of significant disruptive histopathologic features secondary to the type of anesthetic. Additional studies in different clinical contexts are warranted.

Hybrid nanofilms as topical anesthetics for pain-free procedures in dentistry.

Topical anesthetics are widely applied in order to relieve the discomfort and anxiety caused by needle insertion and other painful superficial interventions at the oral cavity. So far, there are no commercially available effective topical anesthetic formulations for that purpose, and the most of developments are related to hydrophilic and low mucoadhesive forms. Therefore, we have prepared different hybrid nanofilms composed of biopolymer matrices (chitosan, pectin, and chitosan-pectin) blended with nanostructured lipid carriers (NLC) loading the eutectic mixture of 5% lidocaine-prilocaine (LDC-PLC), in order to fulfill this gap in the market. These dual systems were processed as hybrid nanofilms by the solvent/casting method, and its mucoadhesive, structural and mechanical properties were detailed. The most appropriate hybrid nanofilm combined the advantages of both pectin (PCT) and NLC components. The resultant material presented sustained LDC-PLC release profile for more than 8 h; permeation across porcine buccal mucosa almost twice higher than control and non-cytotoxicity against 3T3 and HACAT cell lines. Then, the in vivo efficacy of PCT/NLC formulation was compared to biopolymer film and commercial drug, exhibiting the longest-lasting anesthetic effect (> 7 h), assessed by tail flick test in mice. These pectin-based hybrid nanofilms open perspectives for clinical trials and applications beyond Dentistry.

Efficacy of Eutectic Mixture of Local Anesthetics on Pain Control During Extracorporeal Shock Wave Lithotripsy: A Systematic Review and Meta-Analysis.

BACKGROUND The efficacy of a eutectic mixture of local anesthetics (EMLA) for pain control in extracorporeal shock wave lithotripsy is unclear. The aim of this study was to assess the effect of EMLA cream on pain control during extracorporeal shock wave lithotripsy. MATERIAL AND METHODS We searched Medline, EMBASE, and the Cochrane Central Register of Controlled Trials to identify relevant randomized controlled trials that compared the pain control efficacies of EMLA vs. placebo. Study eligibility criteria, participants, and interventions: Randomized controlled trials that compared the effect of EMLA with placebo cream for patients underwent extracorporeal shock wave lithotripsy. Study appraisal and synthesis methods: Two review authors extracted data independently using a designed data extraction form and risk of bias by Cochrane Collaboration's tool. RESULTS Nine studies, including 10 randomized controlled trials with 1167 patients, were eligible. The EMLA group experienced less pain (mean difference, -0.47; 95% confidence interval, -0.78 to -0.16; p=0.003) and shorter duration of lithotripsy (mean difference, -1.70, 95% confidence interval: -2.31 to -1.10, p<0.0001) than the placebo group. There were no significant differences in the number of patients who needed extra intravenous medication (p=0.610), number of patients with insufficient extracorporeal shock wave lithotripsy pain control (p=0.530), and number of patients with opioid adverse effects (p=0.320). Limitations: Long interval between the studies, different kinds of lithotripters. CONCLUSIONS EMLA can reduce pain during the ESWL procedure.

Eficacia analgésica del EMLA en procedimientos transcutáneos. Revisión sistemática / Analgesic efficacy of EMLA in transcutaneous procedures. Systematic review

Los parches de EMLA son frecuentemente utilizados como anestésicos locales durante la realización en procedimientos invasivos. Con el fin de valorar su eficacia y compararla con la de otros analgésicos y anestésicos disponibles, se realizó una revisión sistemática de todos los estudios realizados que cumplieran criterios de inclusión entre los años 1990 y 2019. Población y métodos: la búsqueda bibliográfica de la evidencia disponible fue realizada en las bases de datos de Cochrane Medline y Lilacs. Se incluyeron todos los ECA y revisiones sistemáticas en pacientes menores de 16 años entre los años 1990 y 2019. Resultados: Fueron hallados 31 artículos de los cuales 21 cumplían con los criterios de inclusión. De dichos 21, solamente 8 estudios resultaron de muy buena y excelente calidad metodológica (JADAD). Conclusiones: El EMLA demostró mayor eficacia como analgésico en el 100% de los estudios donde se comparaba respecto del placebo. Sin embargo, no se encontraron diferencias significativas respecto de otros analgésicos farmacológicos y no farmacológicos.(AU)

EMLA patches are commonly used as local anesthetics in minor invasive procedures. To assess efficacy and compare the patches with other available analgesics and anesthetics, a systematic review was conducted evaluated all studies that met the inclusion criteria published between 1990 and 2019. Population and methods: A literature search of the available evidence was conducted in the Cochrane, Medline, and Lilacs databases. All RCTs and systematic reviews in patients younger than 16 years published between 1990 and 2019 were included. Results: 31 articles were identified of which 21 met the inclusion criteria. Of these 21, of only 8 studies the methodology was of very good and excellent quality (JADAD). Conclusions: EMLA better efficacy as an analgesic in 100% of the studies comparing EMLA patches with placebo. However, no significant differences were found when comparing the patches with other pharmacological and non-pharmacological analgesics.(AU)

Lidocaine-Prilocaine Cream Compared With Injected Lidocaine for Vulvar Biopsy: A Randomized Controlled Trial.

OBJECTIVE: To compare pain control during vulvar biopsy after either application of 5% lidocaine-prilocaine cream or injection of 1% lidocaine. METHODS: In a single-site randomized trial, patients who needed vulvar biopsy on a non-hair-bearing surface were recruited from a gynecologic oncology clinic to compare lidocaine-prilocaine cream (placed at least 10 minutes before biopsy) with lidocaine injection (at least 1 minute prior). A sample size of 53 participants in each arm (N=106) was planned. Pain was recorded using a 100 mm visual analog scale at three time points: baseline, after application of anesthesia, and after biopsy. The primary outcome was highest pain score recorded. Secondary outcomes were pain score at biopsy, patient experience, and tolerability and acceptability. Linear regression was used to compare the primary outcome between arms while controlling for baseline vulvar pain. A convenience analysis was performed in March 2019. RESULTS: From October 2018 to March 2019, 38 patients completed informed consent and were randomized. Participants were women with median age of 60 years. Most characteristics between groups were similar. Nineteen were analyzed in the lidocaine-prilocaine group, and 18 were analyzed in the lidocaine injection group. The median highest pain score in the lidocaine-prilocaine group was 20.0 mm vs 56.5 mm in the lidocaine injection group. Controlling for baseline pain, the highest pain score in the lidocaine-prilocaine arm was 25.7 mm lower than in the lidocaine injection arm (95% CI [-45.1 to -6.3]; P<.01). Patients randomized to lidocaine-prilocaine had a significantly better experience than those receiving injected lidocaine (median experience score 2.0 mm vs 17.0 mm; P=.02). CONCLUSION: Lidocaine-prilocaine cream before vulvar biopsy resulted in a lower maximum pain score and a significantly better patient rating of the biopsy experience when compared with lidocaine injection. Lidocaine-prilocaine cream, alone, is a reasonable option to use for vulvar biopsy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03654417.

Comparing the effects of cold compress and Xyla-p cream on hemodynamic changes in hemodialysis patients during venipuncture.

Background The vital signs reflect the physiological state of patients in various clinical conditions. The purpose of this study was to compare the effects of cold compress and Xyla-P cream on hemodynamical changes during venipuncture in hemodialysis patients. Methods and Material In this clinical trial study, 50 patients under hemodialysis were selected by simple random sampling. The patients were then randomly assigned to either Xyla-P cream, cold compress or placebo groups. The vital signs (blood pressure and pulse) were measured upon two intermittent hemodialysis sessions before and after venipuncture. Data were analyzed using repeated measures analysis of variance. Results The mean alternation in systolic blood pressure was significantly different comparing the placebo and cold compress groups before and after intervention (p<0.001). However, the difference was not significant between the Xyla-P cream group and either placebo (p=0.402) or ice compress (p=0.698) groups. The difference of the mean diastolic blood pressure was significant comparing the placebo group with either the Xyla-P cream group (p=0.003) or cold compress group (p<0.001) before and after intervention. In addition, there was a significant difference in the mean number of heartbeats comparing the control group with either the Xyla-P cream group (p<0.001) or cold compress group (p<0.001) before and after the intervention. Conclusions Considering the beneficial effects of ice compress and the Xyla-P cream on reduction of cardiovascular parameters, it is recommended to use these methods in hemodialysis patients during venipuncture.

Anesthetic cream relieves pain after cryotherapy treatment of plantar and palmar warts.

Cryotherapy using liquid nitrogen is an effective and commonly used treatment for palmoplantar warts. However, pain can be a limiting factor in the effective use of cryotherapy. In this study, we found that a single application of anesthetic cream following cryotherapy treatment of warts reduced posttreatment pain and led to improved tolerability of the procedure.

Randomized, double-blind, phase III clinical study of a novel nanotechnological topical anesthetic formulation containing lidocaine 25 mg/g and prilocaine 25 mg/g (nanorap) in skin phototypes I-III patients with ablative fractional CO2 laser treatment indication in the forehead.

BACKGROUND AND OBJECTIVES: Nanotechnology may increase the speed of penetration into the skin. This study evaluated the efficacy, safety, and pharmacokinetics of a novel topical anesthetic nanocapsule formulation (2 g) containing 2.5% lidocaine and 2.5% prilocaine (nanorap-test formulation) compared to placebo (control formulation) in skin types I-III patients of both sexes submitted to the ablative fractional CO2 laser treatment. METHODS: The patients (n = 120) included in this double-blind, single-center, randomized trial, received topical application of 2 g of the test formulation (50 mg lidocaine + 50 mg prilocaine) and placebo on the forehead region. Efficacy was assessed as pain sensation in four quadrants of each side of the forehead using a visual analogue scale immediately (0 min) and at 30, 60, and 90 minutes after laser application compared to placebo. The safety and tolerability of the test product were evaluated based on the occurrence of systemic adverse events as well as the occurrence of immediate and late skin reactions. Pharmacokinetic evaluation was performed in plasma of eight patients using a validated LC-MS/MS method for drugs quantification. RESULTS: Nanorap induced a clinically significant reduction in the pain assessment at all evaluated times (57.2%, 41.6%, 38.6%, and 37.3% at 0, 30, 60, and 90 minutes after drug application, respectively. Mean values of Cmax were 14.20 and 5.36 ng/ml and tmax were 3.5 and 1.8 hour for lidocaine and prilocaine, respectively. No systemic adverse events were observed. CONCLUSION: The nanorap formulation demonstrated a clinically and statistically significant efficacy providing analgesia after the ablative fractional CO2 laser therapy in the investigated patients, when compared to placebo. The product also presented good safety and tolerability. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.

Interventions for intra-operative pain relief during postpartum mini-laparotomy tubal ligation.

BACKGROUND: Postpartum mini-laparotomy tubal ligation (PPTL) is a contraceptive method that works by interrupting the patency of the fallopian tubes. Several methods are used for intraoperative pain relief, such as systemic administration of opioids or intraperitoneal instillation of lidocaine. OBJECTIVES: To evaluate the effectiveness of and adverse effects associated with interventions for pain relief in women undergoing PPTL. SEARCH METHODS: We searched for eligible studies published on or before 31 July 2017 in the CENTRAL Register of Studies Online, MEDLINE, Embase, PsycINFO, and CINAHL. We examined review articles and searched registers of ongoing clinical trials, citation lists of included studies, key textbooks, grey literature, and previous systematic reviews for potentially relevant studies. SELECTION CRITERIA: We included randomised controlled trials (RCT) that compared perioperative pain relief measures during PPTL. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the titles, abstracts, and full-text articles of potentially relevant studies for inclusion. We extracted the data from the included studies, assessed risk of bias, and calculated and compared results. Discrepancies were resolved by discussion, or by consulting a third review author. We computed the inverse variance risk ratio (RR) with 95% confidence interval (CI) for binary outcomes, and the mean difference (MD) with 95% CI for continuous variables. MAIN RESULTS: We found only three RCTs, in which a total of 230 postpartum women participated. Most of our analyses were based on relatively small numbers of patients and studies. Overall, the certainty of evidence regarding the effectiveness of interventions was low, due to risk of bias and imprecision. We found very low-certainty evidence regarding the safety of interventions because of risk of bias and imprecision. Two studies had unclear risk of selection bias. One study had unclear risk of reporting bias and a high risk of other bias associated with the study protocol.Women who received an intraperitoneal instillation of lidocaine experienced lower intensity intraperitoneal pain than those given a placebo (pooled MD -3.34, 95% CI -4.19 to -2.49, three studies, 190 participants, low-certainty evidence), or an intramuscular injection of morphine (MD -4.8, 95% CI -6.43 to -3.17, one study, 40 participants, low-certainty evidence). We found no clear difference in intraperitoneal pain between women who had an intramuscular injection of morphine added to an intraperitoneal instillation of lidocaine and those who had an intraperitoneal instillation of lidocaine alone (MD -0.40, 95% CI -1.52 to 0.72, one study, 40 participants, low-certainty evidence). An intramuscular injection of morphine alone was not effective for intraperitoneal pain relief compared to placebo (MD 0.50, 95% CI -1.33 to 2.33, one study, 40 women, low-certainty evidence). None of the studies reported any serious adverse events but the evidence was very low-certainty. Intraperitoneal instillation of lidocaine may reduce the number of women requiring additional pain control when compared to placebo (RR 0.27, 95% CI 0.17 to 0.44, three studies, 190 women, low-certainty evidence). AUTHORS' CONCLUSIONS: An intraperitoneal instillation of lidocaine during postpartum mini-laparotomy tubal ligation before fallopian tubes were tied may offer better intraperitoneal pain control, although the evidence regarding adverse effects is uncertain. We found no clear difference in intraperitoneal pain between women who received a combination of an injection of morphine, and intraperitoneal instillation of lidocaine and those who received an intraperitoneal instillation of lidocaine alone. These results must be interpreted with caution, since the evidence overall was low to very low-certainty.

Analgesic effect of trigger point injection and EMLA for shoulder pain in patients undergoing total laparoscopic hysterectomy: A randomized controlled study.

BACKGROUD: The purpose of this study was to evaluate the effects of trigger point injection (TPI) and eutectic mixture local anesthetics (EMLA) cream on the postoperative shoulder pain in patients undergoing total laparoscopic hysterectomy. METHODS: In this randomized, single-blinded, and controlled study, total 75 patients were randomly allocated to TPI group (n = 25), EMLA group (n = 25), and control group (n = 25). TPI group received TPIs with 2 mL of 0.2% ropivacaine, and EMLA group received an occlusive dressing with EMLA cream 2 g on both shoulders. Overall, abdominal, and shoulder pains were evaluated at rest and in motion on postoperative day 3. RESULTS: The incidence of shoulder pain was significantly reduced in EMLA group (56%) compared to control (88%) or TPI (88%) groups (P = .025 in both); the severity of shoulder pain was mitigated in EMLA and TPI groups compared to control group (P < .001, each). Consequently, the overall pain decreased in EMLA group and TPI group (P = .023). The patients with exercise habit (n = 31) showed lower incidence of pain than patients without exercise habit (n = 26) (P = .002, P = .005, and P = .037 in overall, abdominal, and shoulder pain, respectively). TPI or EMLA treatments decreased shoulder pain irrespective of exercise habit (P = .001 and P < .001, respectively), but decreased overall pain only in patients without exercise habit (P = .019). Lastly, EMLA lowered overall pain score at the time of first analgesic request in ward compared to control group (P = .02). CONCLUSIONS: TPI and EMLA with occlusive dressing effectively reduced the shoulder pain after total laparoscopic hysterectomy.

Comparison of EMLA and Diclofenac on Reduction of Pain and Phlebitis Caused by Peripheral IV Catheter: A Randomized-Controlled Trial Study.

Peripheral venous catheters (PVC) are often used to provide hydration, medications, and blood products when the length of therapy is expected to be less than 1 week. Pain and phlebitis are frequent complications of PVC. Diclofenac and EMLA have been used to minimize these adverse effects; however, conflicting results have been reported regarding which has better outcomes. This double-blind, randomized controlled trial was conducted to compare the efficacy of EMLA and Diclofenac (TDP) in attenuating PVC pain and phlebitis. The inpatient setting was chosen because of the higher frequency of PVC insertions, allowing for a sufficient sample size. One hundred fifty-four subjects were randomly assigned to three groups: EMLA patch (n = 61), a TDP patch (n = 50), or a patch with lubricant gel (n = 46) as a placebo. The pain was measured by Visual Analogue Scale (VAS). Phlebitis was examined based on Boxter criteria in intervals of 6, 12, 18, 24, and 48 hours after PVC insertion. The mean score of VAS was 41.86 ± 22.49 for the control, 39.40 ± 21.60 for TDP, and 38.77 ± 23.28 for the EMLA group, with no significant differences in pain severity between the three groups. The rate of phlebitis in the group with EMLA was significantly higher than the other two groups at 6, 12, and 18 hours (p = 0.02, p = 0.003 and p = 0.04, respectively). In all interval times, the rate of phlebitis in the TDP group was significantly lower than the other groups. Compared with men, women experienced higher rate of phlebitis and intensity of PVC pain. EMLA and TDP had similar analgesic effects, but phlebitis was less frequently observed with TDP, suggesting TDP as a potential medication for reducing pain and phlebitis before PVC insertion.

Fortacin™ Spray for the Treatment of Premature Ejaculation.

Premature ejaculation (PE) is a common complaint of male sexual dysfunction affecting men and their partners and consequently causing significant personal and interpersonal distress. Increased sensitivity of the glans penis and abnormalities of the afferent-efferent reflex pathway within the ejaculatory process are involved in the occurrence of PE. Drugs that either selectively reduce penile sensitization or modify the afferent-efferent reflex are well established therapeutic options for PE. Fortacin™ is the first topical treatment to be officially approved for the treatment of primary PE in adult men, and is mentioned as an experimental aerosol (as TEMPE) in the current European Association of Urology guidelines. It was approved for use in the European Union and launched in the United Kingdom in November 2016. Fortacin™ is a eutectic-like mixture of lidocaine 150 mg/mL and prilocaine 50 mg/mL that meets the requirements of an ideal treatment for PE because it is fast acting (within 5 minutes), has durable effects, can be easily used "on-demand", and shows minimal side-effects. The metered-dose spray delivery system allows the desensitizing agents to be deposited in a dose-controlled, concentrated film onto the glans penis consequently reducing its sensitivity. This is translated into a delaying of the ejaculatory latency time without adversely affecting the sensation of ejaculation and orgasmic pleasure. The efficacy and safety of Fortacin™ have been proven by means of increased ejaculatory latency, control, and sexual satisfaction in large scale studies demonstrating the significant benefits for both patients and their partners.