Days after disappointing results were released on the effectiveness of Lyrica in treating epilepsy, Pfizer (NYSE: PFE) reported that an extended-release version of the pain drug did show promise in treating fibromyalgia.
According to the New York-based company, patients taking once-daily Lyrica, also known as pregabalin, went for a significantly longer period of time without pain than patients who took a placebo.
In the Phase III trial, 121 patients received either extended-release Lyrica or a placebo pill. After 13 weeks, 54 percent of the Lyrica patients and 71 percent of the placebo patients had much, if not all, of their original pain return. The effectiveness of the drug soon wore off, however. On average, Lyrica stopped providing significant pain relief after 58 days, versus 22 days for the patients getting dummy pills.
The study was the second of three late-stage trials testing a controlled-release version of the Lyrica. In the first study, controlled-release Lyrica relieved pain in some epilepsy patients better than a placebo, but the improvement didn’t last long. A final study in post-herpetic neuralgia is underway.
Pfizer says it will analyze further results of all three studies once data are available with the goal of effectively proving the potential of pregabalin as a once-a-day therapy for fibromyalgia.
“Collectively, the results of these controlled release studies will allow us to better understand the potential of a once-a-day pregabalin treatment regimen,” said Steven J. Romano, MD, a senior vice president at Pfizer. “Reducing the number of times patients need to take their medicine per day while maintaining the same efficacy and safety profile could potentially provide a greater convenience and the potential to enhance treatment adherence and outcomes.”
Fibromyalgia affects more than five million Americans and is characterized by bouts of chronic widespread pain and tenderness lasting for three or more months.
A short-acting version of Lyrica, taken twice a day, was the first medication approved by the Food and Drug Administration for the treatment of fibromyalgia. The drug is also approved in the U.S. for treatment of diabetic peripheral neuropathy, pain from shingles, pain related to spinal cord injury, and seizures in certain adults with epilepsy.
Its side effects include dizziness, sleepiness, blurred vision, weight gain, increased appetite, trouble concentrating, rapid swelling of the skin’s deeper layers, euphoric mood and balance disorder.
Lyrica is Pfizer’s top selling drug with worldwide sales in 2011 of $3.7 billion. Pfizer also recently announced the expansion of its partnership with Cystic Fibrosis Foundation Therapeutics (CFFT).
Under the six-year pre-clinical research program, CFFT will invest up to $58 million into the project to further the discovery and development of potential therapies that target the underlying cause of cystic fibrosis.