Phase III study of Lyrica in Postherpetic Neuralgia shows benefits-Pfizer

Pfizer has announced top-line results from a double-blind Phase III study evaluating Lyrica (pregabalin controlled-release CR) formulation in adult patients with Postherpetic Neuralgia. The results show that pregabalin CR resulted in a statistically significant positive effect compared to placebo in the primary endpoint, time to loss of therapeutic response (LTR) in pain reduction. This study is the final of three Phase III studies of the pregabalin CR formulation conducted to ascertain the potential use of pregabalin as a once-a-day therapy.

The first study in adults with partial onset seizures with epilepsy did not meet its primary endpoint. In the second study in patients with fibromyalgia, pregabalin CR had a statistically significant positive effect compared to placebo in the primary endpoint, time to LTR in pain reduction. Pregabalin CR was well tolerated and the safety profile was consistent with the known profile for pregabalin (immediate release) in PHN patients. The most common adverse events with pregabalin CR were dizziness, somnolence, peripheral edema and weight increase. Full results from the study will be submitted for publication when analyses are complete.