Depomed has released full data from its Phase III Breeze 3 trial of Serada, a controlled-release, oral, non-hormonal treatment for menopausal hot flashes (or hot flushes, if you are from the U.K.) at the 23rd Annual Meeting of the North American Menopause Society (NAMS). This includes a new statistical analysis of the data, which the company carried out after a discussion with the FDA.
Serada combines gabapentin and Depomed's proprietary Acuform drug delivery technology, which retains the drug in the stomach for up to 9 hours and delivers it more slowly.
The trial involved 600 menopausal women who were given Serada or dummy pills. The company originally released top-line data from this trial in October 2011, but based on a discussion with the FDA, changed the statistical analysis method. The previous analysis showed statistical significance for three of the four pre-specified primary endpoints of frequency and severity at four and 12 weeks, but no significance for the key secondary endpoints of frequency and severity at 24 weeks.
In the final reported data, under the new statistical analysis, Serada significantly reduced the frequency and severity of hot flashes and improved sleep in menopausal women through 24 weeks, and significantly more women said that Serada improved their symptoms at 12 and 24 weeks, compared with placebo.
"Insomnia typically worsens with the severity of hot flashes," said Risa Kagan, investigator of the sleep study at the Jordan Research and Education Institute (REDI) at Alta Bates Summit Medical Center. "The data from the Breeze 3 trial may allow us to offer more options for our patients suffering from hot flashes and who have difficulty sleeping."
The Breeze 3 data formed part of the NDA submission to the FDA at the end of July, and the company believes that Serada could be the first non-hormonal and non-antidepressant drug approved by the FDA for hot flashes.
"Hot flashes are a disruptive problem affecting as many as three out of four menopausal women," said JoAnn V. Pinkerton of the University of Virginia in Charlottesville and principal investigator of Breeze 3. "At this time, hormone therapy is the only approved treatment for hot flashes, yet about 40% of symptomatic women either choose not to go on hormones or are not good candidates."
- read the press release