By Saabira Chaudhuri
Pfizer Inc. (>> Pfizer Inc.) said results of a late-stage study of its pregabalin controlled-release formulation as a treatment for fibromyalgia were positive.
The drug company said top-line results of a Phase 3 study evaluating pregabalin controlled-release formulation, also known as Lyrica, in patients with fibromyalgia indicated that it had a statistically significant positive effect compared with a placebo with regards to time to loss of therapeutic response.
Pfizer described fibromyalgia as a common pain condition in the U.S. affecting more than five million Americans and characterized by chronic widespread pain and tenderness lasting for three or more months.
The most recent study is the second of three Phase 3 studies of the pregabalin controlled-release formulation, which Pfizer said will determine the potential use of pregabalin as a once-a-day therapy.
Last week, Pfizer had revealed that a Phase 3 study showed Lyrica as a potential epilepsy treatment didn't meet the primary endpoint for a change in seizure frequency. Monday, the drug company noted that the final study in post-herpetic neuralgia is ongoing.
"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, head of Pfizer's Global Primary Care Business Unit's Medicines Development Group. "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."
Shares edged up 12 cents to $23.98 in recent premarket trading. The stock has risen 22% in the past year.
Write to Saabira Chaudhuri at [email protected]
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