A newly approved antidepressant’s formula for success has a little something to do with S-E-X.
Vilazodone, which is marketed by Clinical Data Inc. under the brand name Viibyrd, reportedly causes minimal interference with users’ sexual desire, a side effect endemic among other depression medication. The drug was cleared for use by the Food and Drug Administration on Friday, marking the beginning of what could be a multibillion-dollar windfall for Clinical Data.
The drug is effective for the treatment of major depressive disorder, mitigating symptoms within one week of use, according to a study published in the Journal of Clinical Psychology in 2009. The FDA approved the drug for use in 10-, 20- and 40-milligram doses.
Clinical Data expects that the drug will be a blockbuster. Major depression is the number one cause of disability among individuals ages 15-44 in U.S. and affects nearly 15 million American adults, according to the National Institute of Mental Health. While medication has proven effective at curbing the effects of the disorder, many users abandon treatment after the onset of undesirable side effects such as reduced sexual desire and obesity.
"We're going to be extremely well positioned in a category where under 50 percent of individuals get satisfaction on their first line therapy," Clinical Data Chief Executive Drew Fromkin told Reuters in an interview last year.
"I absolutely believe that this drug can be north of a $1 billion drug," Fromkin said.
The drug still caused increased risk of suicide in adults ages 18-24, but the side effect tapers off among users older than 24 and actually decreases suicidal tendencies in users over the age of 65.
Market interest in Clinical Data, the company that owns the rights to the drug, exploded after news of the approval hit.
The pharmaceutical company’s shares thrust north of $17 on the Nasdaq during after-hours trading, up nearly 15 percent since the exchange closed Friday evening.