An Analysis of Rescue Medication Utilization from a 3-Month, Randomized, Double-Blind, Placebo-Controlled Study in Patients with Chronic Low Back Pain Treated with Single-Entity, Twice-Daily, Extended-Release Hydrocodone.

OBJECTIVE: To evaluate the durability of pain relief provided by a new formulation of single-entity, hydrocodone extended-release (ER) (Zohydro(®) ER) throughout the 12-hour dosing interval by examining patterns of rescue medication use. DESIGN: Phase 3, enriched enrollment, randomized withdrawal study with an open-label, conversion/titration phase (≤6 weeks) followed by a placebo-controlled, double-blind treatment phase (12 weeks). SETTING: Fifty-seven study sites in the United States enrolled patients. SUBJECTS: One hundred and fifty-one opioid-experienced subjects with moderate to severe chronic low back pain who were treated with hydrocodone ER once every 12 hours. METHODS: Post hoc analysis of rescue medication use by frequency and distribution of use following the morning and evening dose of hydrocodone ER. RESULTS: No rescue medication was used following the morning or evening dose of hydrocodone ER during 36.0% and 76.7% of the dosing days, respectively. Time distribution of rescue medication use showed that 79.3% of all rescue medication doses were administered following the morning dose, with the highest rate of usage (46.2%) occurring 4-8 hours postdose, followed by 18.7% and 14.4% usage 0-4 and 8-12 hours postdose, respectively. Examination of the three 4-hour intervals following the evening dose of hydrocodone ER revealed similar minimal rescue medication use (5.6-8.2%). CONCLUSIONS: End-of-dose failure was not observed based on the use of rescue medication after administration of single-entity, twice daily, hydrocodone ER capsules (Zohydro ER).

Adult cancer pain.

Pain is a common symptom associated with cancer and its treatment. Pain management is an important aspect of oncologic care, and unrelieved pain significantly comprises overall quality of life. These NCCN Guidelines list the principles of management and acknowledge the range of complex decisions faced in the management oncologic pain. In addition to pain assessment techniques, these guidelines provide principles of use, dosing, management of adverse effects, and safe handling procedures of pharmacologic therapies and discuss a multidisciplinary approach for the management of cancer pain.

Peripheral neuromodulation for the treatment of refractory trigeminal neuralgia.

Trigeminal neuralgia is a type of orofacial pain that is diagnosed in 150,000 individuals each year, with an incidence of 12.6 per 100,000 person-years and a prevalence of 155 cases per 1,000,000 in the United States. Trigeminal neuralgia pain is characterized by sudden, severe, brief, stabbing or lancinating, recurrent episodes of pain in the distribution of one or more branches of the trigeminal nerve, which can cause significant suffering for the affected patient population. In many patients, a combination of medication and interventional treatments can be therapeutic, but is not always successful. Peripheral nerve stimulation has gained popularity as a simple and effective neuromodulation technique for the treatment of many pain conditions, including chronic headache disorders. Specifically in trigeminal neuralgia, neurostimulation of the supraorbital and infraorbital nerves may serve to provide relief of neuropathic pain by targeting the distal nerves that supply sensation to the areas of the face where the pain attacks occur, producing a field of paresthesia within the peripheral distribution of pain through the creation of an electric field in the vicinity of the leads. The purpose of the present case report is to introduce a new, less-invasive interventional technique, and to describe the authors' first experience with supraorbital and infraorbital neurostimulation therapy for the treatment of trigeminal neuralgia in a patient who had failed previous conservative management.