Clinical Data ($CLDA) has elbowed its way into the crowded market for antidepressants, winning FDA approval for a new drug it in-licensed from Merck KGaA. Regulators signed off on three doses of vilazodone for major depressive disorder, which will now head to the pharmacy under the name Viibryd, touting data that the drug is less likely to hinder patients' sex life.
Antidepressants target a growing $10 billion market in the U.S. and providers like to have a long list of potential therapies to pick from, as patients often have to go through several prescriptions before finding a drug that works for them. Clinical Data is hoping that patients will prefer Viibryd over other therapies will unsettling side effects, such as a weakened libido.
"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." Merck has earned two packages of Clinical Data stock worth $25 million, along with royalties on sales.
In its press release on Friday Clinical Data acknowledged that the exact mechanism of action for Viibryd isn't fully understood, "but is thought to be related to its enhancement of serotonergic activity in the central nervous system through selective inhibition of serotonin reuptake. Viibryd is also a partial agonist at serotonergic 5HT1A receptors."
"Viibryd is the only antidepressant that is a selective serotonin reuptake inhibitor and 5HT1A receptor partial agonist," said Drew Fromkin, president and CEO of Clinical Data. "It is also the first drug that the company has developed, and to have received marketing approval from the FDA on its first review is a significant milestone for Clinical Data."
- here's Clinical Data's release