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Pregabalin (Lyrica) Fails Study in Adolescents With Fibromyalgia

Treatment equivalent to placebo in phase IV trial

Top-line results have been reported from a double-blind, phase IV study evaluating the safety and efficacy of pregabalin (Lyrica, Pfizer) capsules CV in adolescents (12 to 17 years of age) with fibromyalgia.

The study’s primary endpoint was not achieved as there was not a statistically significant difference between pregabalin and placebo in the mean pain score. The treatment difference was 0.66 points, which reflects an improvement of 1.60 points from baseline for pregabalin-treated patients and 0.94 points for the placebo group (P = 0.121).

The study was conducted to fulfill a post-marketing commitment required by the FDA when pregabalin was approved for the management of fibromyalgia. The safety and efficacy of pregabalin in pediatric patients have not been established.

A total of 107 adolescent patients were enrolled in this 15-week, double-blind, randomized, placebo-controlled study at centers in the U.S., Europe, and Asia. The study was the first large pharmacological treatment trial to be completed in this population.

Pregabalin was administered twice daily. The dosage started at 75 mg/day and was optimized over a 3-week period, based on tolerability and response, to a dosage of 75, 150, 300, or 450 mg/day, with the optimized dosage maintained for the next 12 weeks.

The safety profile observed in this study was consistent with the known profile for pregabalin in prior fibromyalgia studies in adults, with the exception of mild nausea, which occurred at a higher rate in pregabalin-treated patients. The most common adverse events in pregabalin-treated patients included dizziness, nausea, headache, increased weight, and fatigue.

Lyrica (pregabalin) is approved for five indications in the U.S., of which four are in the therapeutic area of pain. These indications include neuropathic pain associated with diabetic peripheral neuropathy; post-herpetic neuralgia; neuropathic pain associated with spinal cord injury; fibromyalgia; and partial onset-seizures in adults with epilepsy who take one or more drugs for seizures.

Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior in patients taking these medications for any indication. There have been post-marketing reports of angioedema and hypersensitivity with pregabalin. Treatment with pregabalin may cause dizziness, somnolence, xerostomia, edema, and blurred vision.

Other common adverse events include weight gain, constipation, euphoric mood, balance disorder, increased appetite, and abnormal thinking (primarily difficulty with concentration and attention).

Source: Pfizer; March 12, 2015.

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