Depomed, Inc. announced that it has completed enrollment of Breeze 3, the company's pivotal phase III clinical trial evaluating Serada (extended release gabapentin tablets) for the non-hormonal treatment of menopausal hot flashes.

“We are pleased to reach this important milestone in Serada's development. We continue to expect Breeze 3 will be successful based on our study design, and look forward to reporting results in the fourth quarter of this year,” said Carl A Pelzel, president and chief executive officer of Depomed.

“We appreciate the efforts of all the investigators and others who have made this possible,” added Dr Mike Sweeney, Depomed's vice president, Research and Development.

Breeze 3 is a randomized, double-blind, placebo-controlled study of approximately 600 patients. Patients have been randomized into one of two treatment arms, with patients receiving either placebo or a total dose of 1800mg of Serada dosed 600mg in the morning and 1200mg in the evening.

The co-primary efficacy endpoints in the study will be 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. The treatment duration of the study will be 24 weeks, to address the FDA's view that an effective drug should also demonstrate persistence of efficacy at 24 weeks.

Breeze 3 is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. An SPA is an agreement with the FDA that a proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support a product candidate's regulatory approval.

Hot flashes, which affect 32 million women in the US 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 profuse 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.

Depomed, Inc. is a specialty pharmaceutical company with one approved product on the market and has developed another approved product. Gralise (gabapentin) is a once-daily treatment approved in the United States for management of Post-Herpetic Neuralgia (PHN) and has been licensed to Abbott Products, Inc.