Impact of Serada on SleepThe second abstract assessed the impact of Serada on two measures of sleep – the Insomnia Severity Index (ISI) Score and the daily sleep interference (S/I) score. At baseline, women had an ISI Score of >17 indicating moderate insomnia (17.54, Serada and 17.33, placebo) and an S/I score of >7 indicating moderate-to-severe sleep disturbance (7.3, Serada and 7.4, placebo).
After 12 weeks of treatment, Serada produced clinically meaningful improvement in ISI scores (-8.7 vs. -6.3 placebo, p=0.0044) and in S/I scores (-3.6 vs. -2.8 placebo, p=0.0056). These reductions were maintained throughout week 24: ISI score change of -8.6 vs. -6.2 placebo, p=0.0056; and S/I score change of -3.9 vs. -3.0 placebo, p=0.0084).
"Hot flashes can impact many aspects of a woman's quality of life, especially her ability to sleep. In fact, insomnia typically worsens with the severity of hot flashes," said
, M.D., investigator of the sleep study at the Jordan Research and Education Institute (REDI) at Alta Bates Summit Medical Center, and Clinical Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences,
University of California
, San Francisco. "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."
BREEZE 3 Trial Design
BREEZE 3 is a randomized, double-blind, placebo-controlled study of approximately 600 post-menopausal women experiencing 7 or more moderate-to-severe hot flashes each day. Patients were randomized into one of two treatment arms, with patients receiving either placebo or a total dose of 1800mg of Serada dosed as 600mg in the morning and 1200mg in the evening. The co-primary efficacy endpoints in the study were 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.
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 can impact women's overall quality 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 source of 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 profuse sweating or severe chills that would not affect a person with a properly functioning thermoregulatory mechanism.
Serada is a non-hormonal, non-antidepressant investigational treatment for hot flashes that involves an extended-release formulation of gabapentin in combination with Depomed's proprietary Acuform
drug delivery technology. By combining gabapentin with the Acuform technology, Serada is absorbed slowly into the upper gastrointestinal tract over several hours rather than immediately to ensure a steady release of medication and to help reduce potential side effects. Serada is not approved to treat any condition.
Depomed, Inc. is a specialty pharmaceutical company with three approved and marketed products. Gralise
(gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Zipsor
(diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults. Glumetza
(metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the
. Depomed formulates its products and product candidates with its proven, proprietary Acuform
drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website,
"Safe Harbor" Statement
under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to our regulatory filings and potential benefits of our product candidates and other risks detailed in the company's Securities
and Exchange Commission filings, including the company's Annual Report on Form 10-K for the year ended December 31, 2011 and the Quarterly Report on Form 10-Q for the quarter ended June 30, 2012. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
August J. Moretti