The U.S. Food and Drug Administration is expected to announce a decision Friday on the first pill to treat postpartum depression, experts say luck I spoke with my fingers firmly crossed for approval.
Zranolone, a steroid drug that rapidly repairs dysregulated neural networks in the brain, is the second drug approved for the condition, thought to affect one in seven women. The other is Zurlesso (brexanolone). Approved by FDA in 2019. However, this drug is not available to many women because it is administered over time and requires hospitalization.
No such barrier exists for Zranolone, a tablet taken at home once daily for two weeks. For many women, one to two courses of medication per year are sufficient to enter and maintain remission. Dr. Christina Derigiannidis—Director of Women’s Behavioral Health and Principal Investigator of New Drug Clinical Trials at Zucker Hillside Hospital in Queens, N.Y.—said. luck.
Improved in just 3 days
Zranolone “provided rapid relief of depressive symptoms as early as day 3 after two doses of the drug, with continued improvement up to day 15,” said Derjiannidis, which lasts for 45 days. added.
The drug’s fast-acting and transient nature contrasts with standard-of-care antidepressants that may otherwise be prescribed. These drugs—usually selective serotonin reuptake inhibitors (SSRIs) and related drugs that raise serotonin levels in the brain—can take four to six weeks to become fully effective, Dr. Derjanidis said. It will take 2-3 months to appear.
A woman with postpartum depression can’t wait months for her symptoms to subside, she says, even though she’s busy preserving a new life, her own, and possibly the lives of other children. says. It’s a life-saving option. “
“It’s like the Z-Pak for depression,” says medical director Dr. Craig Chepke. Excel Psychiatry Associates He lives in Huntersville, North Carolina, and is an occasional consultant to Sage Therapeutics, creators of Zranolon, he told Fortune.
He refers to azithromycin, a five-day fast-acting tablet often prescribed by general practitioners for bacterial infections such as bronchitis and pneumonia.
“This is exactly how primary care providers want to treat depression,” Zranoron said. “It fits the model that they’re used to. They’ll feel more comfortable that it’s like treating a urinary tract infection or a sinus infection, and they’ll say, ‘I can do this.'”
Major depressive disorder can be treated with drugs
The FDA may choose whether to approve it for use in patients with postpartum depression, major depressive disorder, or both.
Until now, depression meds have typically been different, “like different flavors of vanilla,” Chepke said.
“Do you want French vanilla or vanilla beans?” he asks rhetorically. “When the treatments are so similar, it’s like falling off a cliff if you don’t start responding quickly to the first or his second.”
Zranolone works differently and works much more quickly, so it “gives a lot of hope to people who have had trouble before,” he says.
By 2021, an estimated 8% of American adults, or 21 million people, will have experienced at least one major depressive episode. This means the drug has the potential to save millions of people in the United States alone, transforming the depression paradigm from a chronic condition that requires lifelong medication to, for many, occasional short-term flare-ups. It can turn into an acute illness that requires intermittent medication. .
Many people with depression “don’t want the stigma or burden of basically taking daily medicine forever. That’s what most people do.” [with diagnosed depression] That’s how it ends up,” Chepke says.
No weight gain, decreased libido, test results
Another bonus: clinical trials showed that patients taking zranolone did not experience weight gain or decreased libido (an SSRI-specific side effect that is often a “deal killer” for patients).
“And even if there are side effects, they don’t last longer than two weeks, because you’re only taking it for two weeks,” Chepke said of Zranolone. “It changes the math for many who would otherwise have stopped taking medication.”
When the FDA approves a new drug that is a controlled substance, the U.S. Drug Enforcement Administration has 90 days to assign a schedule to the new drug.Chepke predicts that it will be designated Schedule IV Drugs or drugs with a low potential for abuse or dependence such as Xanax, Valium, Ativan, Ambian.
From there, he expects it will soon be in the hands of desperately needed prescribers and patients.
Depression is still widely considered to be a nasty disease that “gets down at times but bounces back on its own,” he said. “Even within the church, there is this idea of ’too good to be stressed.’ Is required.”
Derijiannidis said Friday’s FDA approval was encouraging words, along with reports encouraging new mothers to seek the help they deserve, for themselves and for their children. waves are surging in.
“Depression can increase the risk of poor birth outcomes,” she says, and such negative outcomes can continue after delivery. Postpartum depression can “affect a mother’s bonding with her baby, forming an attachment, and affecting her child’s growth and development.”
“For the sake of mothers, babies and families, we want women to talk to a trusted health care provider about their symptoms as soon as possible.”
