US FDA's Internal Debate On Sage's Brexanolone Spills Into Open During Panel Review
Bob Temple and Ellis Unger discuss feasibility of studies for postpartum depression drug as advisory committee members wait to discuss the dosing questions they had been convened to consider.
You may also be interested in...
US FDA wants Sage Therapeutics to explore Zulresso use in alternative settings in a postmarketing trial. A successful study could expand access to the new approved brexanolone, whose administration is now long, complicated, and restricted to certified healthcare facilities.
Advisory committee strongly favored approval of postpartum depression therapy, but many members suggest it should be administered in a facility with trained medical staff to avoid potential safety concerns.
US FDA is recommending a REMS requiring continuous monitoring during the 60-hour infusion and no home use, a potential problem for commercial marketing.