FDA AdCom smacks down Alkermes antidepressant drug, making approval unlikely
Briefing documents from the Psychopharmacologic Drugs Advisory Committee earlier this week had cast doubt on the chances of a positive vote.
Briefing documents from the Psychopharmacologic Drugs Advisory Committee earlier this week had cast doubt on the chances of a positive vote.
The Psychopharmacologic Drugs Advisory Committee will meet on Thursday to vote on whether to recommend the FDA approve the drug, ALKS 5461, an opioid for major depressive disorder.