FDA approves brexanolone to treat post-partum depression

March 21, 2019 0 By FM

US FDA approved brexanolone to treat post-partum depression in women.
Marketed under the brand name Zulresso, brexanolone becomes the first-ever drug to receive FDA approval to treat women suffering from the condition, according to Sage Therapeutics,a Massachusetts-based biopharmaceutical company.

The treatment of brexanalone is administered as a single 60-hour intravenous (IV) drip and may involve mild side effects including headache, dizziness or excessive sleepiness.

The FDA announced that the drug will now be available only through a restricted programme called Zulresso Risk Evaluation and Mitigation Strategy (REMS) program that requires the drug to be administered by a health care provider in a certified health care facility, said a company release announcing the approval.

Post-partum depression is a serious mental illness that impacts 1 in 9 new mothers after childbirth. Without any treatment, it can persist for months to even years, according to the National Institute of Mental Health.

Treatment options for postpartum depression used to include counseling or therapy with a mental health professional and resorting to antidepressant medications. No antidepressant medication has been specifically approved by the FDA to treat postpartum depression and they generally did not provide immediate relief of symptoms leading to prolonged reliance on the medication.

Brexanolone had received its “breakthrough therapy designation” from FDA for the treatment of postpartum depression in 2016. Results from two phase III trials of brexanolone, conducted across 30 clinical research centers and specialized psychiatric units in the US were published in the journal The Lancet in August 2018. The studies showed brexanolone to be effective regardless of when postpartum depression symptoms began.

“There are no FDA approved antidepressants for postpartum depression, so approval of the first medication of its kind is a breakthrough for patients,” said Dr. Kristina Deligiannidis, the director of Women’s Behavioral Health at Northwell Health’s Zucker Hillside Hospital in New York, who was involved in two of the drug’s clinical trials as a researcher.

Dr. Jeff Jonas, CEO of Sage Therapeutics, announced that the medication will be available in June, according to a press release. The company confirmed that the drug will likely be priced around $20,000 to $30,000 per treatment.