The U.S. Food and Drug Administration (FDA) has approved Clinical Data Inc. (NASDAQ:CLDA)’s Viibryd tablets for the treatment of major depressive disorder (MDD) in adults.
Viibryd is manufactured by CLDA’s PGxHealth unit and the drug will be available in 10, 20 and 40 milligram tablets.
Clinical Data plans to make Viibryd available in U.S. pharmacies in the second quarter of this year. The company holds exclusive worldwide rights to Viibryd from Merck KGaA, Darmstadt, Germany.
The company said it is also advancing its late-stage drug candidate, Stedivaze, a pharmacologic stress agent in Phase III development for use during myocardial perfusion imaging.
According to the FDA, the most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.
MDD 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.
The World Health Organization estimates that MDD affects around 18 million people in the U.S. More than 212 million prescriptions were written for antidepressants in 2009.
“Major depressive disorder is disabling and prevents a person from functioning normally,” said Thomas Laughrens of the FDA’s Center for Drug Evaluation and Research. “Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression.”
Shares of Clinical Data, which closed Friday's regular trading 1.3 percent higher at $15.03, surged 48.70 percent to $22.35 in the pre-market trading on Monday.