Three days after the drug disappointed in a late-stage epilepsy trial, Pfizer says a Phase III trial of one-way dose of its blockbuster Lyrica in fibromyalgia patients has had some success.
Top-line results from the study evaluating Lyrica (pregabalin) controlled-release (CR) formulation indicate that it had a statistically significant positive effect compared to placebo in the primary endpoint, namely time to loss of therapeutic response (LTR). Fibromyalgia, which affects more than five million Americans, is characterised by chronic widespread pain and tenderness lasting for three or more months; the short-acting version is already approved for the condition.
In the trial, 121 patients who had earlier experienced a 50% or higher reduction in pain compared to baseline were next entered into a 13-week, phase during which they received pregabalin CR or placebo. The primary endpoint, defined as the time to LTR occurred in 34 of 63 (54.0%) patients in the pregabalin group compared with 41 of 58 (70.7%) subjects on placebo; the median time to LTR was 58 days in the former and 22 days in the latter group.
The study is the second of three Phase III of Lyrica CR to report top-line findings, and the first, in adults with partial onset seizures with epilepsy, did not meet its primary endpoint. The final study in post-herpetic neuralgia is ongoing.
Steven Romano, head of the medicines development group for the global primary care business unit at Pfizer, said that “collectively, the results of these controlled-release studies will allow us to better understand the potential of a once-a-day pregabalin treatment regimen. He added that “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”.
Cystic fibrosis pact expanded
Meantime, Pfizer has expanded its collaboration with Cystic Fibrosis Foundation Therapeutics designed to discover new drugs to treat people with the most common mutation of CF, Delta F508.
Under the new six-year pre-clinical research programme with Pfizer, CFFT will invest up to $58 million into the project, the goal for which is to advance one or more candidates into the clinic by the end of the multiyear collaboration. In people with the Delta F508 mutation, a defective protein called CFTR does not fold correctly and is unable to reach the cell surface, where it is needed to help maintain the proper flow of salt and fluids into the airways. As a result, thick secretions form in the airways, leading to serious lung infections and lung damage.
