Sage Therapeutics has pegged the wholesale acquisition price of the oral postpartum depression (PPD) drug Zurzuvae (zuranolone) at $15,900 for a 14-day course of the therapy. The drug, co-developed by Biogen, won the FDA green light in August. The companies plan on launching the drug in December. The DEA has classified zuranolone as Schedule IV,…
FDA approves zuranolone for postpartum depression but issues complete response letter for major depressive disorder
FDA’s approval of Zurzuvae for PPD could mark a significant shift in the fight against postpartum depression (PPD). On August 4, the agency gave the green light for the oral medication, although it declined its use for major depressive disorder (MDD), citing insufficient evidence of effectiveness. The former approval represents a milestone as the first ever…
Zuranolone shows promise in treating postpartum depression
Sage Therapeutics’ (NSDQ:SAGE) and Biogen’s (NSDQ:BIIB) experimental depression drug zuranolone fared well in a Phase 3 clinical trial comparing it to placebo in the treatment of postpartum depression. The investigational drug demonstrated meaningful improvements in terms of the baseline 17-item Hamilton Rating Scale for Depression (HAMD-17) score, the most common clinician-administered depression assessment scoring system.…