Clinical Data Inc. has found an antidepressant drug candidate that has met the main goal in a second late-stage study. The new drug candidate is called vilazodone.
Clinical Data this week announced positive results from the second of two Phase 3 clinical trials of its product candidate vilazodone. The new drug will be used to treat major depression if approved by the FDA. Phase 3 clinical trials are the final phase of research required by the FDA before it can consider a drug for approval.
Vilazodone has a new dual approach as a selective serotonin reuptake inhibitor and a partial agonist of the 5-1a receptor.
In the study, vilazodone offered statistically significant results on the primary endpoint and secondary efficacy endpoints, said Clinical Data in its news release.
Moreover, the effects of vilazodone on sexual function were comparable to that of a placebo.
The sexual side effects of the new drug are important because many antidepressants cause or worsen sexual dysfunction.
However, the study failed to replicate a proprietary lead biomarker. This is a test that predicts response to treatment which had been identified in the first late-stage trial as potentially associated with response to vilazodone.
The company also noted that the new drug was “well tolerated” by patients, with only one patient out of the 240 subjects in the study discontinuing the drug because of diarrhea. Three additional patients stopped taking the drug because of nausea.
Doctors and patients alike are looking for treatments for major depressive disorder, noted Carol Reed, executive vice president and chief medical officer of Clinical Data. The positive results from this study, along with the results of the prior Phase 3 and long-term safety studies, will provide a basis for the company’s New Drug Application (NDA) filing with the U.S. Food and Drug Administration by the end of 2009.
Source: Clinical Data Inc. news release