The U.S. Food and Drug Administration today approved Sage Therapeutics compound Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.
“Today’s approval of ZULRESSO represents a game-changing approach to treating PPD,” said Samantha Meltzer Brody, primary investigator of the ZULRESSO clinical trials in a press release. “The potential to rapidly reduce symptoms in this critical disorder is an exciting milestone in women’s mental health. PPD is recognized to have a significant and long-term impact on women and their families, but with ZULRESSO we may finally have the opportunity to change that.”
Zulresso can be received through a restricted program called the Zulresso REMS Program that requires a health care provider administer the drug in a certified health care facility. Zulresso is administered to the patients as a continuous IV infusion over a total of 60 hours (2.5 days). Patients are monitored continuously and should not drive, operate machinery, or do other dangerous activities until feelings of sleepiness from the treatment have completely gone away.
The approval of ZULRESSO is based on the results of three multicenter, randomized, double-blind, parallel-group, placebo-controlled trials, designed to evaluate the safety and effectiveness of ZULRESSO in women with moderate and severe PPD, aged between 18 and 45 years who were ≤6 months postpartum at screening and who had onset of symptoms no earlier than the third trimester and no later than the first four weeks following delivery.
“We are proud to be a part of this important moment in mental health, creating the opportunity for an unprecedented change in the way postpartum depression is thought about and treated moving forward,” said Jeff Jonas, M.D., chief executive officer of Sage.
Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond. A major depressive episode occurs following childbirth, although symptoms can start during pregnancy. It is characterized by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure and may present with symptoms such as cognitive impairment, feelings of worthlessness or guilt, or suicidal ideation.
Zulresso was judged under Priority Review by FDA and given Breakthrough Therapy designation in the year 2016. It is the first medicine for the treatment of postpartum depression, is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor. The FDA approval is for the treatment of PPD in adults, pending DEA scheduling. The drug has been granted PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA).