The application was accepted under priority review status, according to the Cambridge, Mass.-based company. If approved, the drug would be the first therapy specifically indicated to treat postpartum depression – the most common medical complication of childbirth.
The company’s drug is an allosteric modulator of synaptic and extrasynaptic GABA-A receptors. As an allosteric modulator, it works to indirectly regulate the activity of neurotransmitter receptors, rather than simply turning them on or off.
Sage’s NDA included data from two Phase III trials that evaluated the safety and efficacy of brexanolone in women ages 18 to 45 with moderate and severe postpartum depression. At all doses in both trials, brexanolone demonstrated a significant mean reduction from baseline in the Hamilton Rating Scale for Depression score after 60 hours compared to placebo. The most common adverse events across all treatment groups were headache, dizziness and somnolence, according to Sage.
Because Sage’s drug is a new molecular entity with a new mechanism of action, the FDA plans to hold an advisory committee meeting to discuss the company’s application. The regulatory agency is slated to make a decision regarding Sage’s NDA by December 19.