Experts Worry About Price of New Postpartum Pill for Depression

The newly approved postpartum depression treatment pill, Zurzuvae, has been hailed as a medical milestone, but the price will still be controversial, according to Axios.

The first pill specifically intended to treat severe depression after childbirth, a condition that affects an estimated 400,000 people each year, received Food and Drug Administration approval last week.

The pill, whose generic name is zuranolone, is a version of Sage Therapeutics’ infused drug that was approved in 2019 but proved too costly and difficult to administer.

The medication was not approved for treating the more common condition of major depressive disorder, or MDD, so its use will be limited to postpartum depression.

Sage Therapeutics, which partnered with Biogen on the new pill, saw its share price plummet when the FDA denied its approval for treating MDD. Company officials said they are “committed” to ensuring the drug remains accessible to the public, but pointed out that since it cannot be prescribed for the much larger patient population that suffers from MDD, several factors will affect its ultimate price to the public.

The National Institute of Mental Health estimated that in 2021, about 14.5 million adults in the U.S. had at least one major depressive episode with severe impairment. Zuranolone was approved as a once-daily pill to be taken for two weeks only for those suffering with severe depression after giving birth, says Axios. In clinical trials, the drug showed benefits for many patients within three days, making it faster acting than most antidepressants currently on the market.

Mental health experts say they welcome the rapid treatment provided by zuranolone, but suggest patients may want to use it in conjunction with a more traditional psychiatric drug and then transition to something longer term, given the study lasted for only 45 days and researchers are not aware of how long treatment is sustainable beyond that point.

However, the pharmaceutical companies haven’t thrown in the towel and will likely reapply to the FDA.

“We and our collaborators Biogen had been preparing wholeheartedly” to launch zuranolone with both postpartum and MDD indications,” said Sage Therapeutics’ CEO Barry Greene. “We now have to go back given the results (from the FDA stance) and re-engage payers.” The company also announced plans for a “pipeline prioritization and a workforce reorganization” after the FDA rejection that saw its stock plummet 50%, says Endpoints.

“Progress in treating depression is not keeping pace with the accelerating prevalence and burden of this debilitating disease,” added Greene. “Despite current treatment options, people with depression continue to struggle. A change in the treatment paradigm and approved of novel options is desperately needed.”

It’s expected that zuranolone will launch in the fourth quarter of this year after being scheduled by the Drug Enforcement Administration.