Posted by Michael Wonder on 12 Oct 2017
U.S. FDA approves Lyrica CR (pregabalin) extended-release tablets
12 October 2017 - New formulation may offer convenience to patients.
Pfizer announced today that the US FDA has approved Lyrica CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of post-herpetic neuralgia (PHN). Lyrica CR did not receive approval for the management of fibromyalgia.
The efficacy and safety of Lyrica CR in PHN was established in a randomised placebo-controlled clinical trial conducted in a total of 801 patients with PHN who entered single-blind treatment with Lyrica CR. As both pDPN and PHN are peripheral neuropathic pain conditions, the PHN data was supportive of both the pDPN and PHN indications. The randomised trial included a six-week single-blind, dose optimisation phase followed by a 13 week double-blind phase. In the PHN study, 73.6% of patients in the LYRICA CR group achieved at least 50% improvement in pain intensity compared with 54.6% in the placebo group.
