Sage May Be Forced To Simplify Brexanolone Dosing Regimen
Advisory committee members warned of dosing errors and other potential problems with the titration/taper regimen used in the clinical trials, arguing a simpler dosing schedule also could increase patient access.
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.
After an advisory committee recommended approval for the postpartum depression treatment if administered under a REMS program at certified centers, Sage submitted a proposed REMS, causing the agency to extend the PDUFA date three months.
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.