Somaxon Pharmaceuticals rolled snake eyes yesterday when its experimental drug to curb gambling failed to benefit patients in a midstage clinical trial.

The San Diego specialty drug maker said volunteers diagnosed as pathological gamblers who took one of two doses of the drug, nalmefene hydrochloride, did no better in controlling their addiction than those who took a dummy pill.

Secondary goals of the Phase 2/3 study were also not reached. Side effects included insomnia, nausea and dizziness, and some treated patients also had elevated liver enzymes, a condition associated with liver damage.

“It was always a higher risk development program largely because no drug has ever been approved for this impulse control disorder, though we did think it had a reasonable chance for success,” said Jeff Raser, senior vice president and a co-founder of Somaxon. “It's a disappointment.”

Raser said the company will analyse all of its nalmefene data before it decides what to do with the program. The company has also tested nalmefene in a Phase 2 study as an aid to stop smoking.

While the nalmefene results are a setback, Somaxon and its investors are focused more on the fate of the company's most advanced drug candidate, an experimental insomnia treatment called Silenor.

The company is awaiting results of a final Silenor Phase 3 study, which is expected this month. If the study is successful, as three other Phase 3 studies have been, Somaxon expects to seek Food and Drug Administration approval for the sleeping pill in the third quarter of next year.

Somaxon is one of a growing number of specialty pharmaceutical companies, which usually license late-stage experimental drugs developed by other firms, or find new uses for already approved drugs.

Silenor is no exception: It is a low-dose form of an already approved drug, doxepin, which is used to treat depression.

If approved as an insomnia treatment, Silenor would face competition in the crowded field of prescription sleeping pills, which include Ambien, Lunesta and Sonata.

Silenor's closest competitor would probably be Rozerem, a drug that was approved last year and is made by Takeda Pharmaceuticals. Like Rozerem, Silenor is considered to be free of narcoticlike effects and potential for abuse, and would not be listed as a controlled substance.

In July, Silenor hit a hitch when the FDA requested more preclinical data on the drug, including carcinogenicity studies that will take two years to complete and could delay a regulatory decision on the drug.

Somaxon said the FDA has indicated that it will allow the company to complete the carcinogenicity studies after the drug is approved, if other preclinical data already submitted proves adequate.

Somaxon, which employs 40, was founded in 2003 and went public last December. The company's shares fell 12 cents yesterday, to close at $14.07.

-- San Diego Union Tribune

Source: http://www.eog.com/news/full-article.aspx?id=13464