Clinical Data Wins Approval for New Antidepressant

Clinical Data Inc. won U.S. approval to sell a new type of antidepressant that may not affect sexual function, a side effect of older treatments. The shares surged in extended trading.

The Food and Drug Administration cleared three doses of tablets with the medicine vilazodone, the agency said today in a statement. Clinical Data, of Newton, Massachusetts, licensed global rights to the drug from Darmstadt, Germany-based Merck KGaA (MRK) and plans to market it under the brand name Viibryd.

Depression is one of the most common mental illnesses. About 6.7 percent of U.S. adults have had major depression in the past 12 months, including about a third of whom had severe cases, according to the National Institute of Mental Health. Vilazodone is the first new type of medicine to treat depression in more than a decade, according to the company.

“Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression,” said Thomas Laughren, director of the FDA’s division of psychiatry drugs, in the statement.

Clinical Data gained $2.21, or 15 percent, to $17.24 at 5:53 p.m. New York time before extended trading was halted on the Nasdaq Stock Market. The company’s options had surged to a record earlier this week as investors bet ahead of the FDA’s decision, with the most-traded contracts today being February puts to sell the stock for $12.50.

Sexual Function

Vilazodone was shown to have a similar effect on sexual function as a placebo pill in data presented in November. Clinical Data owes Merck two payments in stock valued at 9.5 million euros ($12.9 million) each after approval and marketing of vilazodone, according to the companies’ licensing agreement. Merck is also entitled to royalties from sales.

Antidepressants were the third-most popular type of drug in the U.S. in 2009 with 168.7 million prescriptions, according to IMS Health Inc., a Norwalk, Connecticut research firm. Depression medicines generated $9.9 billion in sales that year, making them the fourth best-selling category of drugs. Treatments include Cymbalta, from Indianapolis-based Eli Lilly & Co. (LLY) and Lexapro, from New York-based Forest Laboratories Inc. (FRX)

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.

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