The Food and Drug Administration announced Friday that it has approved the first oral treatment for postpartum depression. The drug, called zranolone, is a once-daily tablet marketed under the brand name Zurzubae by pharmaceutical companies Sage Therapeutics and Biogen.
Zranolone is approved for use in adults for: Treatment of postpartum depressionIt is an episode of major depression that can begin after childbirth or later in pregnancy and affects an estimated 15% of women in the weeks or months after childbirth.
“The availability of oral medications will be a beneficial option for many women coping with extreme and sometimes life-threatening emotions,” said Tiffany Falchione, M.D., director of psychiatry at the FDA’s Center for Drug Evaluation and Research. To tell. said in statement.
After taking the tablets for just two weeks, many patients see immediate relief, the company said.
“Women report rapid improvements in their depression as early as day three,” says Christina, who has previously led research on the drug and worked as a paid consultant for Sage and Biogen. Dr. Derjanidis said.
Postpartum depression can be severe and can last for months or even years in some women.
“This is not baby blues. This is not a normal, temporary hormonal fluctuation that affects your mood after giving birth and then goes away on its own,” Derjanidis said.
Prior to this, the only approved treatment for postpartum depression was also from Sage Therapeutics. Brexanolone, which is marketed as Zlesso and should be administered as an infusion.it was Approved by FDA First treatment in 2019 postpartum depression.
Similar to that drug, Sage and Biogen said they were considering zranolone the work As a fast-acting steroid that binds to GABA receptors in the brain, it effectively resets neurotransmitters released by patients suffering from depression.
“It may help restore brain function by rapidly rebalancing dysregulated neural networks in depressed patients. will target,” the companies said in a release. last year.
The Zuranolone label will release boxed products. caveat Patients should not drive or operate machinery for 12 hours after taking the drug. According to the FDA, the most common side effects include drowsiness, dizziness, diarrhea, fatigue, colds and urinary tract infections. Risk of suicidal ideation. The drug can harm an unborn baby, so women who take it should use contraception, the FDA said.
Sahar McMahon entered a clinical trial after developing depression and anxiety after giving birth to her second child.
“I felt like myself right away,” she told CBS News. “This will save many women and families.”
The drug must go through a 90-day Drug Enforcement Administration scheduling process, according to the companies. Saidbefore entering the market.
The companies have not yet disclosed how much the new drug will cost, according to the Associated Press.
Not approved for major depression
enterprise was advertising The once-daily pill is intended to be taken in as little as two weeks as part of a possible new “paradigm” for treating major depression soon.they sought FDA approval to treat both postpartum depression and major depressive disorder.
But with Friday’s decision, the FDA only officially approved a drug to treat postpartum depression.
Doctors can usually prescribe unapproved treatments, “unofficial” Therefore, without approval, pharmaceutical companies cannot market the tablets for such uses.
and releaseThe drug companies said the FDA had told them more research was needed because “they have not provided substantial evidence of efficacy to support the approval of zranolone” for the treatment of major depressive disorder.
and Recent clinical trialsThe researchers said a 14-day dose of zranolone tablets appeared to help prevent further depressive episodes in many patients for months before the next dose was required.
It differs from many common antidepressantsDrugs such as selective serotonin reuptake inhibitors and SSRIs take time to work and many patients may take them for the rest of their lives.
But these findings follow the company’s setback in 2019, when a pivotal Phase 3 trial of its treatment aims to outperform placebo in a “statistically significant reduction” in treating depression. This was after the pharmaceutical company revealed that it had not been able to achieve
At the time, Sage Therapeutics Said Their data showed that some patients in the study did not have measurable drug concentrations in their bodies, suggesting that they forgot doses and clouded the results.
“There is consistent improvement in depressive symptoms associated with zranolone compared to placebo. We have seen improvement,” said Dr. Maha Radhakrishnan, chief medical officer at Biogen. was saying december phone Both approaches outline plans to market the drug.
–Roxana Saberi contributed to this report.
