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FDA approves pregabalin extended-release for diabetic neuropathy
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The FDA approved pregabalin extended-release tablets CV as a once-daily therapy for the management of pain associated with diabetic peripheral neuropathy and postherpetic neuralgia, Pfizer announced in a press release.
Pregabalin (Lyrica CR) did not receive approval for the management of fibromyalgia, according to the release.
“Lyrica CR was developed to offer patients an effective treatment option with the convenience of once-daily dosing,” James M. Rusnak, MD, PhD, chief development officer, internal medicine, Pfizer Global Product Development, said in a statement. “It provides an important option for patients and health care providers managing these often-debilitating conditions.”
In a randomized, double-blind, placebo-controlled trial with 801 patients with postherpetic neuralgia, 73.6% of patients in the pregabalin group achieved at least 50% improvement in pain intensity after a 6-week, single-blind dose-optimization phase followed by a 13-week, double-blind phase, compared with 54.6% of patients assigned placebo. As postherpetic neuralgia and diabetic peripheral neuropathy are both neuropathic pain conditions, the data were supportive of both indications. The most common adverse reactions reported with pregabalin were dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth and weight gain.