Once-Daily Lyrica Formulation Wins FDA Approval

Thursday, October 12, 2017 | FDA Approval/Clearance , Headache & Pain , Phase 3/4 Trials , Research and Publications , Pfizer


The FDA has approved Lyrica CR (pregabalin, Pfizer) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN). The efficacy and safety of the new formulation was established in a randomized placebo-controlled clinical trial conducted in which 801 patients with PHN entered a six-week single-blind treatment with Lyrica CR followed by a 13-week double-blind phase. According to the results, 73.6 percent of patients in the Lyrica CR group achieved at least 50 percent improvement in pain intensity compared with 54.6 percent in the placebo group. As both pDPN and PHN are peripheral neuropathic pain conditions, the PHN data was supportive of both the pDPN and PHN indications.

Of note, Lyrica CR did not receive approval for the management of fibromyalgia.

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