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Somaxon Pharmaceuticals Announces Positive Results in a Phase II Dose-Finding Study of Low-Dose Doxepin in Adults With Primary Sleep Maintenance Insomnia

Posted on: Thursday, 6 January 2005, 12:00 CST

Somaxon Pharmaceuticals Inc., a specialty pharmaceutical company focused on developing and marketing products for the treatment of neuro-psychiatric disorders, today announced that low-dose doxepin demonstrated statistically significant results in a Phase II dose-finding study in adults with primary sleep maintenance insomnia. There was no difference in adverse events or next day residual effects with low-dose doxepin versus placebo.

Results

-- Doxepin 3mg and 6mg demonstrated statistically significant improvement in the primary endpoint by polysomnography (PSG)-defined Wake Time During Sleep (WTDS) vs. placebo (3mg, p = 0.0004), (6mg, p=0.0025)

-- Doxepin 1mg, 3mg, and 6mg demonstrated statistically significant improvement in the secondary endpoints of PSG-defined Wake After Sleep Onset (WASO), Sleep Efficiency (SE) and Total Sleep Time (TST) vs. placebo.

-- Doxepin demonstrated statistically significant improvement in sleep efficiency in each third of the night vs. placebo.

-- Latency to Persistent Sleep (LPS) showed a dose-dependent reduction, though not statistically significant vs. placebo.

Somaxon President and Chief Executive Officer Ken Cohen stated, "We are pleased with the achievement of this important clinical milestone. This trial provides evidence that low doses of doxepin may be effective for sleep maintenance insomnia in adults. We are expecting the results from a similar Phase II study in the elderly in the first quarter of 2005, and we plan to initiate our pivotal Phase III trials by mid-year."

"Low-dose doxepin potentially represents an attractive alternative for the treatment of insomnia. Doxepin works via an entirely different mechanism of action than currently approved insomnia treatments and, unlike available hypnotics, it is not a Schedule IV controlled substance," commented Thomas Roth, Ph.D., Chief, Division Head of the Sleep Disorders & Research Center at Henry Ford Hospital.

Study Design

The Phase II study was a randomized, multi-center, double-blind, placebo-controlled, four-way cross-over, dose response study of 61 patients diagnosed with primary sleep maintenance insomnia. Three dose levels of doxepin (1 mg, 3 mg, 6 mg) were assessed in patients from 18-64 years of age. The primary endpoint was to evaluate the effect of various dose levels of doxepin on Wake Time During Sleep (WTDS). Other secondary endpoints as well as safety and tolerability were also measured.

Randomized patients reported greater than or equal to 3 months of DSM IV primary insomnia, greater than or equal to 60 minutes of Wake Time During Sleep (WTDS) and greater than or equal to 10 minutes of Latency to Persistent Sleep (LPS) confirmed by screening polysomnography (PSG). Each treatment period consisted of two consecutive nights of study dosing separated by a 5 or 12 day drug free interval.

About Doxepin

Doxepin HCL is a tricyclic compound currently approved for the treatment of depression. The recommended daily dose for the treatment of depression ranges from 75 mg to 300 mg. Somaxon licensed intellectual property surrounding the method of use of doxepin at low doses for the treatment of insomnia and is currently evaluating the product in Phase II clinical trials.

About Insomnia

Insomnia is a growing health problem in the United States. It is believed that more than 10 million people suffer from chronic insomnia and up to an additional 50 million people suffer from some form of insomnia each year. In a Gallup Sleep in America poll, 22 percent of adults surveyed reported difficulty falling asleep and 43 percent reported problems associated with waking up at night.

About Somaxon Pharmaceuticals

Somaxon Pharmaceuticals is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of neuro-psychiatric diseases and disorders and has several product candidates in development. Headquartered in San Diego, CA, Somaxon's lead clinical program is to evaluate low-dose doxepin for the treatment of insomnia. The Company also licensed North American rights to oral nalmefene hydrochloride, an opioid antagonist, for the treatment of pathological gambling. This product has completed Phase II clinical trials. In addition, the Company licensed world-wide rights to the use of acamprosate, a GABA-A agonist and NMDA antagonist, for the treatment of movement disorders and other conditions. The Company is initiating product development work on this compound. Somaxon intends to initiate Phase III clinical trials with low-dose doxepin for the treatment of insomnia and oral nalmefene for the treatment of pathological gambling in 2005.

Source: Business Wire

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