Sage Therapeutics announced on May 30 that the FDA has accepted a new drug marketing application (NDA) for brexanolone (SAGE-547) intravenous injection to treat postpartum depression and granted priority review status. The PDUFA is scheduled to expire on December 19, 2018.
Brexanolone is an allosteric modulator of the gamma-aminobutyric acid type A receptor (GABAA receptor) and is capable of modulating the functions of GABAA receptors located within synapses and outside of the synapse simultaneously, restoring the intracerebral GABAA receptor and The balance between NMDA receptor (N-methyl-D-aspartate receptor) activity has the potential to treat mental disorders including depression.
Sage Therapeutics’ submission of the listing application is based on data from two randomized, double-blind, parallel-grouped, placebo-controlled phase III studies (Study 202B and Study 202C) conducted in the United States on the Hummingbird project. Both studies evaluated the efficacy and safety of brexanolone in women aged 18-45 years with severe postpartum depression. When the patient entered the group, the time of delivery was less than 6 months. The time of depression was not earlier than the 3rd pregnancy and not later than 1 month after childbirth.
The results showed that all doses of brexanolone in both studies were significantly more degraded than baseline in the HAM-D scale score after 60 h of injection, and were well tolerated and had similar rates of adverse events.
Brexanolone intravenous injection has received the FDA’s breakthrough drug qualification and EMA’s priority drug approval for the indication of postpartum depression. If approved, brexanolone will be the first drug to treat postpartum depression and will be Sage Therapeutics’ first commercialized product.
Postpartum depression is the most common complication of childbirth and usually occurs during the third trimester or the first month after childbirth. In the United States, about 8%-20% of women giving birth during the first delivery will experience post-production depression. Postpartum depression is manifested by marked dysfunction, depressive emotions, loss of interest in newborns, and associated depressive symptoms such as loss of appetite, sleep disturbance, lack of concentration, malaise, lack of self-confidence, and suicidal tendencies. It is the primary cause of postpartum suicide for pregnant women. At present, there is not yet any drug that specifically targets this disease.