According to study results presented Monday, May 1 at the American Academy of Neurology’s annual meeting, a significant number of fibromyalgia patients treated with Pfizer’s Lyrica (generic name pregabalin) experienced a 50 percent or more reduction in pain. They also reported significant improvements in overall health status and outcomes, including measures such as physical function and ability to perform everyday tasks.
The 14-week placebo-controlled study included 745 patients with fibromyalgia who were randomized into four groups. One group received a placebo while the other three groups received 300mg, 450mg, or 600mg of Lyrica daily. Of those patients taking 600mg of Lyrica a day, 30 percent said their pain was cut in half or better; 27 percent of those taking 450mg a day and 24 percent of those taking 300mg also reported a similar level of pain relief. Of those taking the placebo, 15 percent reported pain reduction of 50 percent or better.
The most common side effects reported in the study were dizziness and sleepiness, followed by weight gain, headache and peripheral edema.
The results of this study have been submitted to the FDA as part of a supplemental New Drug Application for Lyrica for the treatment of fibromyalgia. If approved, Lyrica will be the first drug ever to receive FDA approval for fibromyalgia. Currently Lyrica has received FDA approval for the treatment of diabetic neuropathic pain, postherpetic neuralgia and the adjunctive treatment of partial onset seizures in adults with epilepsy.
Published On: May 06, 2007