Depomed, Inc. (NASDAQ:DEPO) announced today top-line results from the BREEZE 1 and 2 Phase 3 clinical trials evaluating the safety and efficacy of SeradaTM, an investigational non-hormonal extended release formulation of gabapentin for the treatment of menopausal hot flashes.
In the higher dose treatment arm of the two doses evaluated, the 1800mg dose achieved positive results at 4 weeks. All four co-primary endpoints of the 1800mg dose at 4 weeks demonstrated significant reductions in frequency and severity in both clinical trials (p-values ranged from 0.0001 to 0.004). Of the other four co-primary endpoints of the 1800mg dose at 12 weeks, one endpoint was positive>
In the lower dose treatment arm, the 1200mg dose at 4 weeks achieved statistical significance in three of the four co-primary endpoints. Frequency was significantly reduced in both clinical trials (p-values of 0.0024 and 0.0117) at four weeks. Severity was significantly reduced in only one trial (p-value 0.0016). Of the other four co-primary endpoints of the 1200mg dose at 12 weeks, one endpoint was positive>
The primary endpoints in the studies were a statistically significant reduction in the frequency and severity of menopausal hot flashes relative to placebo after 4 weeks and 12 weeks of stable treatment. Both patients’ and clinicians’ impression of overall improvement in the higher dose treatment arm was highly statistically significant relative to placebo in both studies.
Additional efficacy and safety details will be provided on Depomed’s investor conference call scheduled for today, October 12, 2009.
“We remain very enthusiastic about Serada and our menopausal hot flash program. There is a large unmet need for a non-hormonal hot flash therapy, and we believe Serada has the potential to address that need,” said Carl Pelzel, Depomed’s president and chief executive officer. “We look forward to meeting with the FDA later this quarter to discuss these results, the path to approval and any additional clinical work that may be required.”
“We are pleased to see that the 1800mg dose clearly demonstrated Serada’s efficacy at 4 weeks while the lower 1200mg dose at 4 weeks achieved three of the four co-primary endpoints. While the drug effect in the studies was what we expected to see, there was an unexpectedly high placebo effect, particularly in the latter part of one of the studies,” said Dr. Michael Sweeney, M.D., Depomed’s vice president, Research and Development. “We need to extensively analyze the data to better understand all of the implications in order to refine our approach to any additional development.”