Depomed (DEPO) Releases Hot Flash Treatment Results of Two Phase 3 Trials
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 Serada.
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.
In the higher dose treatment arm of the two doses evaluated, the 1800mg dose achieved positive results at 4 weeks. Of the other four co-primary endpoints of the 1800mg dose at 12 weeks, one endpoint was positive (p=0.0026) while the other three endpoints did not achieve statistical significance.
In the lower dose treatment arm, the 1200mg dose at 4 weeks achieved statistical significance in three of the four co-primary endpoints. Of the other four co-primary endpoints of the 1200mg dose at 12 weeks, one endpoint was positive (p=0.0024) while the other three endpoints did not achieve statistical significance.
"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. 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," said Carl Pelzel, Depomed's President and CEO.
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.
In the higher dose treatment arm of the two doses evaluated, the 1800mg dose achieved positive results at 4 weeks. Of the other four co-primary endpoints of the 1800mg dose at 12 weeks, one endpoint was positive (p=0.0026) while the other three endpoints did not achieve statistical significance.
In the lower dose treatment arm, the 1200mg dose at 4 weeks achieved statistical significance in three of the four co-primary endpoints. Of the other four co-primary endpoints of the 1200mg dose at 12 weeks, one endpoint was positive (p=0.0024) while the other three endpoints did not achieve statistical significance.
"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. 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," said Carl Pelzel, Depomed's President and CEO.
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