FDA Approves Neuropathic Pain Treatment
The approval was based on data from a randomized placebo-controlled trial conducted in 801 patients with postherpetic neuralgia.
The Food and Drug Administration (FDA) has approved Lyrica CR (pregabalin extended-release tablets; Pfizer), a once-daily treatment for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN).
The approval was based on data from a randomized placebo-controlled trial conducted in 801 patients with PHN. The trial included a 6-week single-blind, dose optimization phase followed by a 13-week double-blind phase. Compared to placebo, more patients in the Lyrica CR group experienced at least a 50% improvement in pain intensity (73.6% vs 54.6%). Data from the PHN study was used to support the pDPN indication as both are peripheral neuropathic pain indications.
The most common side effects associated with therapy included dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain.
The efficacy of Lyrica CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.
Lyrica CR is a Schedule V controlled substance. It will be available in 82.5mg, 165mg, and 330mg tablets strengths in 30-count bottles.
US FDA approves LYRICA® CR (pregabalin) extended-release tablets CV [news release]. New York, NY: Pfizer; October 12, 2017. Accessed October 25 2017.