After receiving guidance from U.S. regulators, pharmaceutical company Depomed has announced a late-stage trial of its drug candidate for menopausal hot flashes. The company met with the U.S. Food and Drug Administration (FDA) in December to discuss Serada after the experimental drug failed to meet its primary endpoint in two clinical trials. California-based Depomed plans to initiate the trial, which will be known as Breeze 3, at the end of April 2010 and to complete the trial by the end of 2011. The FDA has agreed to review the proposed Breeze 3 protocol under the FDA’s Special Protocol Assessment (SPA) process.
The Breeze 3 trial will involve up to 600 patients, who will receive either a placebo or two daily doses of Serada. The primary endpoints are reductions in the mean frequency of moderate-to-severe hot flashes, and the average severity of hot flashes, measured after four and 12 weeks of stable treatment. Serada is an extended-release form of gabapentin, a drug typically used to treat nerve pain and epilepsy.
A successful Breeze 3 trial may help Depomed recover from a difficult fourth quarter. Shares in Depomed dropped 33 percent last year following the announcement of the earlier trial data. The drug had performed well at the four-week mark, but failed to achieve a statistically significant result by week 12. A November article in BioMed Reports speculated that Depomed may be ready to bounce back. Shares in the company were up 1 percent Tuesday.
It is thought that hot flashes are caused by irregularities in the body’s temperature-regulating mechanism (located in the hypothalamus). Hot flashes affect more than 32 million women in the U.S. annually, and are characterized by the sudden onset of body warmth, flushing and sweating. Patients may experience rapid heartbeat, dizziness or nausea. Hot flashes can cause a significant drop in the patient’s quality of life. Many sufferers report an increase in insomnia caused by hot flashes.