2019-03-21| R&DTrials & Approvals

FDA Approves New Drug for Specific Treatment of Postpartum Depression

by Rajaneesh K. Gopinath
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By Rajaneesh K. Gopinath, Ph.D.

Sage therapeutics’ Brexanolone became the first drug to be developed and approved for this condition. It will be marketed as an intravenous (IV) injection under the name ZULRESSOTM.

Postpartum depression (PPD) is a crippling obstacle faced by women after childbirth and is often characterized by anxiety, a feeling of ineptitude and a sense of doom. Sometimes experienced even during pregnancy, this mood disorder often gets in the way of new mothers bonding with their babies. Without proper screening, the condition gets undiagnosed and lasts for years. In some extreme cases, it leads to physical harm to either the mother or newborn.


ZULRESSO – the First of its Kind

Sage Therapeutic Inc., a biopharmaceutical company based in Cambridge, Massachusetts developed a novel drug called Brexanolone to address this issue. It is a synthetic form of allopregnanolone, a hormone whose natural production in the body decreases post pregnancy, thereby leading to PPD. The drug acts as an allosteric modulator of both synaptic and extrasynaptic GABAA receptors, to control the depression. After moving in the right direction, receiving priority review and breakthrough therapy designation, on March 19th, the USFDA announced the approval of ZULRESSO, making it the first and only treatment for PPD. The news positively impacted the stocks of Sage Therapeutics, raising it by 5 percent.


Clinical Trial Data

The approval was based on the results yielded from three multicenter, randomized, double-blind, placebo-controlled trials, involving women in the age group of 18 and 45 years suffering from moderate to severe PPD. In comparison to placebo, the drug recorded a significant reduction in the Hamilton Rating Scale for Depression (HAM-D) total score, when delivered as a single infusion over the course of 60 hours. A reduction of symptoms was also seen at 24 hours. The most common adverse reactions were excessive sedation, sleepiness, dry mouth, loss of consciousness and flushing.

Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research voiced her views regarding the approval. “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. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option,” she said. “Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient” she added.

The drug is currently expensive with a single dose costing about $34,000 but Sage is in talks with insurance companies to ensure that it becomes affordable for low income families.




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