Viibryd approved in US for treating major depressive disorder

The US regulator FDA has given Clinical Data green light for its new drug Viibryd (vilazodone HCl tablets) as a treatment for major depressive disorder (MDD) in adults. Vilazodone was approved by the FDA for use in the United States in 10mg, 20mg, and 40mg doses. Clinical Data said the drug is the first selective serotonin reuptake inhibitor (SSRI) and partial 5HT1A receptor partial agonist to achieve approval in the U.S.  However, the company admited the exact mechanism of action of combined SSRI and partial 5HT1A antagonism effected by Viibryd is not yet fully understood. The drug firm in-licensed Viibryd from Merck KGaA.

“Viibryd is the only antidepressant that is a selective serotonin reuptake inhibitor and 5HT1A receptor partial agonist,” commented Drew Fromkin, president and CEO of Clinical Data. “It is also the first drug that the company has developed, and to have received marketing approval from the FDA on its first review is a significant milestone for Clinical Data.”

The efficacy of Viibryd was established through two eight-week multicenter placebo-controlled clinical trials in adults who met the criteria for MDD. Compared with patients given placebo, those receiving Viibryd experienced significant improvements in depressive symptoms measured by the Montgomery-Asberg Depression Rating Scale.

Antidepressants target a growing $10 billion market in the U.S. and providers like to have a long list of potential therapies to pick from, as patients often have to go through several prescriptions before finding a drug that works for them. Clinical Data is hoping that patients will prefer Viibryd over other therapies will unsettling side effects, such as a weakened libido.