Lyrica, Pfizer's ($PFE) once-daily controlled-release formulation of pregabalin, has had some ups and downs this week in its three pivotal Phase III studies. In a top-line analysis, the epilepsy trial missed its endpoints but the fibromyalgia study showed better efficacy than placebo.
On the downside, Lyrica missed the main endpoint of the first of three Phase III studies, according to a press release from the company. In the study in patients with epilepsy, once-daily Lyrica was statistically no better than the dummy pills at reducing the number of seizures, though the company attributes this to a higher-than-expected response to placebo. Immediate-release Lyrica has a track record in treating epilepsy, and Pfizer says it is continuing to analyze the results of the once-daily study.
On the upside, in patients with fibromyalgia, a pain condition that affects more than 5 million Americans, once-daily Lyrica was better than placebo for its primary endpoint, which was time to loss of therapeutic response.
The aim of the controlled-release version of Lyrica is to reduce the number of doses that patients have to take. This could potentially improve compliance, and therefore quality of life, particularly in patients with chronic conditions. The third study is still ongoing, looking at Lyrica in post-herpetic neuralgia (the pain after shingles).
- read the press release on epilepsy
- check out the press release on fibromyalgia
Special Report: Pharma's Top 11 Marketing Settlements: Pfizer - Bextra, Geodon, Zyvox and Lyrica
Editor's note: Story updated to include information on the fibromyalgia trial.