FDA approves first drug exclusively intended for female postpartum depression
The FDA recently approved Zulresso, an IV injection that is a positive allosteric modulator of gamma-aminobutyric-acid type A receptors, for treatment of postpartum depression in women aged 18 to 45 years, according to a press release from its manufacturer.
Zulresso (brexanolone, Sage Therapeutics) is the first drug exclusively approved for postpartum depression, which affects one in nine women who have given birth, the release added.
“[This] approval represents a game-changing approach to treating [postpartum depression],” Samantha Meltzer Brody, MD, MPH, director of the perinatal psychiatry program at the University of North Carolina Center for Women’s Mood Disorders, said in the release.
“The potential to rapidly reduce symptoms in this critical disorder is an exciting milestone in women’s mental health. [Postpartum depression] 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,” she added.
Joshua A. Gordon, MD, PhD, director of the National Institute of Mental Health put the approval in some context in a blog on the institute's website.
"Treatment development in psychiatry still has a long way to go. The road from basic science discoveries to novel therapies is long and winding. But here we have evidence that it sometimes leads to success," he wrote. "And for many women, this [approval] is good news. Very good news indeed."
Brexanolone's eapproval was based on three multicenter, randomized, double-blind, parallel-group trials that assessed the safety and effectiveness of brexanolone in women with moderate and severe postpartum depression vs. placebo. Brexanolone reduced some symptoms within 24 hours, had a significant mean reduction vs. baseline score in the women’s Hamilton Rating Scale for Depression and maintained its effect through 30 days of follow-up, according to the press release. The most common adverse events in these studies were flushing, dry mouth and sleepiness, according to Sage Therapeutics.
During an FDA committee meeting in November 2018, FDA clinicians had expressed concerns regarding safety to both mother and child depending on where the drug would be administered. At the time of the hearing, there were no data to indicate what would happen if infusions were not stopped. The FDA provided details that addressed these safety concerns in its own press release that discussed brexanolone’s approval.
Zulresso will be available only through a restricted program called the Zulresso [Risk Evaluation and Mitigation Strategy (REMS)] Program that requires the drug be administered by a health care provider in a certified health care facility. The REMS requires that patients be enrolled in the program prior to administration of the drug. Zulresso is administered as a continuous IV infusion over a total of 60 hours (2.5 days),” the FDA release stated.
“Because of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring (monitors oxygen levels in the blood). While receiving the infusion, patients must be accompanied during interactions with their child(ren),” the FDA release continued, adding that a Boxed Warning will be included with brexanolone to justify the reasons for this distribution policy.
“Patients will be counseled on the risks of Zulresso treatment and instructed that they must be monitored for these effects at a health care facility for the entire 60 hours of infusion. Patients should not drive, operate machinery, or do other dangerous activities until feelings of sleepiness from the treatment have completely gone away,” according to the FDA.
Brexanolone should be available in mid-June, according to Sage Therapeutics’ press release. The company also stated that the initial list price for brexanolone in the United States will be $7,450 per vial, resulting in a projected average one-time course of therapy cost of $34,000 per patient before discounts.
Sage Therapeutics added it considered factors such as the high unmet need of the patient population, the impact of postpartum depression on patients and society, and the clinical value of a one-time treatment with the opportunity for a rapid, acute intervention for the treatment of postpartum depression, a condition where no therapy previously existed when setting the drug's price. – by Janel Miller
Disclosures: Healio Primary Care Today was unable to determine Brody’s relevant financial disclosures prior to publication. – by Janel Miller
Editor's Note: This story has been updated to include comments from Gordon and to provide information about the price for brexanolone.