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Newton-based biotech company Clinical Data Inc. has found an anti-depression disorder drug candidate is delivering positive results and the company intends to file its New Drug Application this year.
Clinical Data (Nasdaq: CLDA) this week announced positive top-line results from the second of two Phase 3 trials of its product candidate vilazodone, which is intended to treat major depressive disorder. 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, Clinical Data claimed.
Moreover, the effects of vilazodone on sexual function were comparable to that of a placebo. This is important, according to the company, because many antidepressants cause or worsen sexual dysfunction. It also was “well tolerated” by the patients — only one patient out of the 240 patients participating in the study discontinued the trial from diarrhea, and three patients stopped the trial because of nausea, the company said.
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 NDA filing.
Last May, Clinical Data closed the acquisition of Maryland-based Avalon Pharmaceuticals Inc. for some $10 million in stock, the company announced .
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