Magazine article Clinical Psychiatry News

Antidepressant Gets Nod; Dual Action Cited

Magazine article Clinical Psychiatry News

Antidepressant Gets Nod; Dual Action Cited

Article excerpt

The Food and Drug Administration's approval of vilazodone hydrochloride in late January for the treatment of major depressive disorder in adults adds another drug to the already large group of antidepressants, though this one could offer a better side effect profile through a novel combined mechanism of action.

"Unlike other antidepressants, Viibryd [vilazodone hydrochloride] is the first and only drug that is both a potent selective serotonin reuptake inhibitor and serotonin 1A [5-[HT.sub.1A]] receptor partial agonist in one single molecule," Clinical Data Inc.'s CEO Drew Fromkin said during a call with analysts and investors on Jan. 24.

Clinical Data's PGxHealth division acquired the rights to develop Viibryd from Merck KGaA. The drug will be marketed under the trade name Viibryd.

"The net effect [of vilazodone] is that it's boosting serotonin ... so it's enhancing serotonin and, at the same time, boosting the serotonin signal for one of the receptors," Dr. Norman Sussman, a professor of psychiatry at the NYU Langone Medical Center, said in an interview.

Vilazodone will be available in 10-, 20-and 40-mg tablets, and the company expects the drug to be available in the second quarter of 2011. As with all other antidepressants, Viibryd will have a boxed warning on the label and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults aged 18-24 during initial treatment.

Based on the result of two 8-week placebo-controlled studies including 861 patients with MDD and a 52-week open-label study including 599 patients, the company believes that the drug is associated with decreased sexual dysfunction, which is something of an Achilles' heel for selective serotonin reuptake inhibitors (SSRIs).

"The problem that you have with serotonin reuptake inhibitors ... is that there are certain quality of life side effects that are associated, like sexual dysfunction and weight gain, that have mitigated the benefits provided in the treatment of anxiety and depression," Dr. Sussman said.

"From my reading, it has most of the same side effects as the SSRIs. It causes nausea and diarrhea. It causes insomnia ... the only thing that didn't come up in the 8-week studies was sexual dysfunction," he said. …

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