West Coast Editor
About two months after starting a Phase III study with its pain drug bicifadine, DOV Pharmaceutical Inc. has launched another, as promised - this time with its anti-anxiety agent ocinaplon.
The Hackensack, N.J.-based company's stock (NASDAQ:DOVP) closed Tuesday at $17.69, down 40 cents.
Officials could not be reached, but DOV said the ocinaplon study will be carried out at about 45 centers, enrolling some 375 outpatients with generalized anxiety disorder (GAD), with a primary endpoint of statistically significant improvement as measured by the Hamilton Anxiety Rating Scale.
After a seven-day placebo lead-in, qualifying patients will be randomized into one of three groups and dosed over a 28-day period with one of three regimens: placebo, 30 mg of ocinaplon twice a day or 60 mg of ocinaplon once a day.
In two Phase II studies in which ocinaplon was administered for either 14 or 28 days, GAD patients given ocinaplon showed less anxiety to a statistically significant degree after one week. After four weeks, the magnitude of reduction was more than yielded in earlier studies with benzodiazepines, serotonin reuptake inhibitors or serotonin/norepinephrine reuptake inhibitors - all commonly prescribed for anxiety.
What's more, ocinaplon patients had no more daytime drowsiness than those on placebo, nor did their anxiety rebound when the drug was stopped, thus dropping the risk of dependency seen in some patients taking benzodiazepines. Ocinaplon selectively modulates a specific subset of GABAa (gamma-amino butyric acid) receptors that DOV believes are involved in anxiety mediation.
GAD is just the first indication among anxiety disorders for which DOV is going after marketing approval. It's also the most common, with a lifetime prevalence of about 5 percent and about 15 million people afflicted in the U.S.
DOV said preclinical studies show ocinaplon produces an anti-anxiety effect at doses 20 times to 40 times lower than doses that produce sedation and muscle relaxation, and 10 times lower than doses that produce amnesia. The compound also was "15 times less likely than Valium to potentiate the sedating effects of alcohol," the company said.
This fall, DOV began the first of four pivotal trials of bicifadine, testing the drug in about 480 patients with moderate to severe acute pain following surgery to have their bunions removed. A new drug application filing is targeted for late 2006. (See BioWorld Today, Sept. 27, 2004.)
A previous member of the DOV portfolio was the subject of a success report this week. San Diego-based Neurocrine Biosciences Inc. said it submitted an NDA for the insomnia drug indiplon, licensed from DOV in 1998. The NDA is for modified-release tablets. Neurocrine submitted the application for immediate-release capsules in October. (See BioWorld Today, Oct. 20, 2004.)