DEPOMED FILES IND APPLICATION FOR GABAPENTIN GR IN TREATING HOT FLASHES

Depomed has submitted an investigational new drug (IND) application to the FDA for Gabapentin GR for the treatment of postmenopausal hot flashes. The company expects to initiate a Phase II clinical trial in the second quarter of 2007.

The Phase II, double-blind, placebo-controlled, multicenter trial will involve approximately 110 postmenopausal women experiencing recurrent moderate to severe hot flashes and will be conducted at approximately 15 sites in the U.S. and Canada. The primary objective of the trial is to determine the optimal dose of Gabapentin GR in reducing the frequency and severity of hot flashes in postmenopausal women. Patients will be randomized into one of four treatment groups, three of which will receive Gabapentin GR and one of which will receive placebo. The total study treatment duration after screening and baseline will be 13 weeks.

The primary endpoint of the trial is a reduction in the frequency and severity of hot flashes relative to baseline. Secondary endpoints include: the efficacy of Gabapentin GR relative to placebo based on changes from baseline to the end of each treatment period; average daily frequency and severity score of hot flashes; and sleep quality.

Gabapentin GR is an investigational extended-release formulation of gabapentin, an FDA-approved drug for the treatment of seizures and postherpetic neuralgia. Formulated with Depomed's AcuForm drug-delivery technology, Gabapentin GR holds the potential to offer women experiencing postmenopausal hot flashes with the relief benefits provided by immediate release formulations of gabapentin, with fewer side effects and a more convenient dosing regimen. Depomed also recently completed patient enrollment in a Phase III clinical trial designed to evaluate the safety and efficacy of Gabapentin GR for the treatment of postherpetic neuralgia.