US FDA approves Clinical Data's Viibryd to treat major depressive disorder

The US Food and Drug Administration on Friday approved Clinical Data’s (Nasdaq: CLDA) Viibryd (vilazodone hydrochloride) to treat major depressive disorder in adults. The news caused the firm’s shares to rise 14.7% to $17.24 in after hours trading that day.

The drug is licensed by the US company from Germany’s Merck KGaA, to whom it paid a $15.6 million milestone last when the FDA accepted the filing for vilazodone (The Pharma Letter May 25, 2010). Clinical Data is expected to seek additional approvals for other psychiatric conditions, such as anxiety disorders. Some analysts believe that, with additional indications cleared, Viibyrd could eventually generate annual sales in excess of $2 billion. In 2009, the market for antidepressants was worth $9.9 billion.

Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a person's lifetime, although some may experience only a single occurrence.