FDA Approves Lyrica CR
October 12, 2017 - Pfizer Inc. (NYSE: PFE) announced today that the United States Food and Drug Administration (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 postherpetic neuralgia (PHN). Lyrica CR did not receive approval for the management of fibromyalgia.
“Lyrica CR was developed to offer patients an effective treatment option with the convenience of once-daily dosing,” said James M. Rusnak, MD, PhD, Chief Development Officer, Internal Medicine, Pfizer Global Product Development. “It provides an important option for patients and health care providers managing these often debilitating pain conditions.”
The efficacy and safety of Lyrica CR in PHN was established in a randomized 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 randomized trial included a six-week single-blind, dose optimization phase followed by a 13-week double-blind phase. In the PHN study, 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.
The most common adverse reactions reported with Lyrica CR were dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth and weight gain.https://www.drugs.com/