Depomed Reports Results From Two Phase 3 Clinical Trials Evaluating Non-Hormonal Therapy For Menopausal Hot Flashes
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Depomed, Inc. (NASDAQ:DEPO) announced 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 (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. 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 (p=0.0024) while the other three endpoints did not achieve statistical significance.
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.
"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."
In each BREEZE study, patients were randomized into three treatment arms: placebo; Serada 1200mg dosed once daily; or Serada 1800mg twice daily (dosed 600mg in the morning and 1200mg in the evening). BREEZE 1 and 2 combined enrolled 1,100 patients. The four co-primary efficacy endpoints in both studies were the reductions in the mean frequency of moderate to severe hot flashes, and the average severity of hot flashes, measured after four weeks and 12 weeks of stable treatment. Patients in the BREEZE 2 study received twelve weeks of treatment, while patients in the BREEZE 1 study were treated for six months in order to assess safety and persistence of efficacy.
Serada was generally well tolerated in both BREEZE trials. The most common adverse events were dizziness and somnolence. The incidence of dizziness in the active arms was between 17% and 24% (compared to 3% for placebo). Somnolence ranged from 7% to 19% in the active arms (compared to 2% or 3% in the placebo arms).
About Menopausal Hot Flashes
Hot flashes, which affect 32 million women in the U.S. annually, are characterized by a sudden, temporary onset of body warmth, flushing and sweating. Hot flashes are disruptive and impact women's overall quality of life, affecting their mood and their ability to sleep. In fact, insomnia typically worsens with the severity of hot flashes. According to the North American Menopause Society, hot flashes are the most common menopause-related discomfort. Research suggests hot flashes occur when the body's internal thermoregulatory mechanism (located in the hypothalamus) becomes irregular, narrowing the body's thermoneutral zone. Thus, even small fluctuations in body temperature can cause menopausal women to experience perfuse sweating or severe chills that would not affect a person with a properly functioning thermoregulatory mechanism.
Serada is an extended-release formulation of gabapentin for the treatment of menopausal hot flashes using Depomed's proprietary Acuform® drug delivery technology. By combining gabapentin with Acuform technology, Serada is absorbed slowly into the upper gastrointestinal tract over several hours rather than immediately. Immediate release formulations of gabapentin have been approved by the FDA to treat neuropathic pain and epilepsy.
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