U.S. health regulators on Friday approved Clinical Data Inc's (CLDA.O) antidepressant vilazodone under the brand name Viibyrd, a potential multibillion-dollar seller that may not interfere with sexual desire as seen with some rival drugs.
The Food and Drug Administration approved Viibyrd at doses of 10 milligrams, 20 mg, and 40 mg for major depressive disorder, or major depression. Clinical Data shares rose nearly 15 percent in extended trading.
Like other antidepressants, Viibyrd will carry a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.
The warning also says data did not show the increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior.
Clinical Data believes its drug's dual mechanism of action and side effect profile will differentiate it from a crowded field.
In clinical trials, vilazodone use did not cause significant weight gain or the negative impact on sexual desire or function seen with many other antidepressants that lead many patients to abandon their medicine.
"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 company is expected to seek additional approvals for other psychiatric conditions, such as anxiety disorders.
Some analysts believe that with additional approvals Viibyrd could eventually garner annual sales in excess of $2 billion.
"Major depressive disorder is disabling and prevents a person from functioning normally," Thomas Laughren, the FDA's, director of the Division of Psychiatry Products, said in a statement.
"Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression," Laughren said.
Clinical Data owns full rights to the drug with Germany's Merck KGaA (MRCG.DE) getting some royalties on sales.
Clinical Data shares rose 14.7 percent to $17.24 in after-hours trading from their Nasdaq close at $15.03. (Reporting by Bill Berkrot; editing by Carol Bishopric)
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