FDA Approves Extended-Release Tablets for Neuropathic Pain

The US Food and Drug Administration recently approved once-daily Lyrica CR (pregabalin) extended-release tablets CV for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia.

Approval for Lyrica CR was based on a randomized placebo-controlled trial that included 801 patients with postherpetic neuralgia. In the study, 73.6% of patients who received Lyrica CR achieved at least a 50% improvement in pain intensity compared with 54.6% in the placebo group. Data on postherpetic neuralgia was considered supportive for diabetic peripheral neuropathy as both are peripheral neuropathic pain conditions.
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Common adverse reactions included dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain.

Lyrcia CR did not receive approval for the management of pain associated with fibromyalgia.

—Melissa Weiss

Reference:

U.S. FDA approves Lyrica CR (pregabalin) extended-release tablets CV [press release]. NYC, New York: Pfizer Inc, October 12, 2017. http://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_lyrica_cr_pregabalin_extended_release_tablets_cv. Accessed October 12, 2017.