Sage Therapeutics Wins First Postpartum Depression Drug Approval

The US Food and Drug Administration (FDA) handed out its first-ever approval for the treatment of postpartum depression (PPD) on Tuesday (March 19) to biopharmaceutical giant Sage Therapeutics (NASDAQ:SAGE).

Called Zulresso (generic name brenaxolone), the drug will be available as an IV injection to treat adult women with PPD, which impacts up to one in seven women, according to the American Psychological Association, and can even start during pregnancy.

In a press release issued by Sage Therapeutics, the company said Zulresso will be available towards the end of June, following scheduling by the US Drug Enforcement Administration, which should take place within 90 days of approval. However, the FDA said in its statement that the treatment will only be available as part of a restricted program, called the Zulresso REMS program, in which a healthcare provider administers the drug in a certified healthcare facility.

Similarly, the patient receiving the drug will be required to be enrolled in the program before being dosed with Zulresso, which will be given as a continuous IV infusion over a 60-hour period.

“PPD is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. PPD can also interfere with the maternal-infant bond,” Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in the FDA’s statement. “This approval marks the first time a drug has been specifically approved to treat PPD, providing an important new treatment option.”

The FDA’s approval of Zulresso is based on two Phase 3 trials in which patients aged 18 to 45 received the 60-hour IV infusion of the drug or a placebo. One of the studies evaluated patients with severe PPD, whereas the other included patients with moderate PPD. Symptoms were improved at the end of the first infusion, and Zulresso remained effective through to a 30-day follow up.

“We are proud to be a part of this important moment in mental health, creating the opportunity for an unprecedented change in the way PPD is thought about and treated moving forward,” Jeff Jonas, MD, CEO of Sage, said in the company’s release.

Symptoms of PPD include anxiety, mood swings, changes in appetite, excessive irritability, sadness, fear of not being a good mother and misery.

Up until Zulresso was approved, typical treatment options for PPD have been antidepressants. The FDA’s nod to Zulresso could potentially pave the way for further treatment options for those living with PPD.

According to ClinicalTrials.gov, there are currently 41 clinical trials underway for PPD options in Canada and the US that are at various stages in the trial process.

Sage Therapeutics is now studying the effectiveness of Zulresso on adolescent women aged 15 to 17. The trial, now in Phase 3, began in May of last year and is expected to be completed in September 2020.

Meanwhile, Marinus Pharmaceuticals (NASDAQ:MRNS) initiated a Phase 2 trial in June 2017 for its drug Ganaxolone for women with PPD. In December, the company revealed positivedata from the study, which indicated 50 percent of the patients who received the drug “achieved remission from depression” by day 34, while 33 percent of the patients’ symptoms were reduced by 60 hours after taking the drug. This trial is expected to be done towards the end of June 2019.

Moving ahead, driving PPD market growth will be an increase in awareness of people living with PPD,according to a Persistence Market Research report. While most treatment options are still antidepressants, the report says pharmaceutical companies working to develop drugs specific for PPD will push the market’s growth.

Following Sage Therapeutics’ announcement after hours on Tuesday, shares of the company jumped from US$156.10 to US$160.73 as of 10:00 a.m. EST on Wednesday (March 20). By Wednesday’s close, the stock had dipped to US$152.46, which is a 5-percent decrease over Wednesday’s trading period.

On TipRanks, Sage has an analyst rating of “strong buy” based off of 11 analysts with an average price target of US$200.64, a high of US$249 and a low estimate of US$90 over a 12-month period. Five analysts all reiterated their positions on Wednesday, each with a “buy” position.

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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.