Depomed Inc. has submitted an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for Gabapentin GR for the treatment of postmenopausal hot flashes. Pending the standard 30-day FDA review period, the company expects to initiate a phase 2 clinical trial in the second quarter of 2007.
"Our meeting with the FDA regarding Gabapentin GR in postmenopausal hot flashes went well and now, less than three weeks later, we are pleased to have submitted the IND application," said Carl Pelzel, executive vice president and chief operating officer of Depomed. "Gabapentin GR holds the potential to become a new treatment option for the approximately 13 mn women in the US who seek treatment for postmenopausal hot flashes each year. We look forward to working closely with the FDA and to doing all that we can to address this unmet medical need."
The phase 2, double-blind, placebo-controlled, multi-centre trial will involve approximately 110 postmenopausal women experiencing recurrent moderate to severe hot flashes and will be conducted at approximately 15 sites in the US 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 randomised into one of four treatment groups, three of which will receive Gabapentin GR and one which will receive placebo. The total study treatment duration after screening and baseline will be 13 weeks.
The primary endpoint of the trial is the frequency and severity of hot flashes, relative to baseline. Secondary endpoints include, among others, 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. Published data on the use of gabapentin in postmenopausal women support the efficacy of the compound to address hot flash symptoms. A study published in the July 2006 issue of Obstetrics and Gynecology reported that gabapentin appeared to be as effective as estrogen in treating hot flashes. In the Position Statement of the North American Menopause Society (NAMS) regarding treatment of menopause-associated vasomotor symptoms (2004), gabapentin is reviewed as a recommended nonhormonal option.
Formulated with Depomed's proprietary 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.