Postpartum Depression Pill Authorized by the FDA

The postpartum depression (PPD) pill in adults was authorized by the U.S. Food and Drug Administration on August 4.

The drug, zuranolone, is given twice daily for two weeks in 50 mg dosages. In two clinical trials, including women who suffered from severe postpartum depression, the medication reduced symptoms as early as three days after the first dose, including anxiety, trouble sleeping, loss of pleasure, poor energy, guilt, or social isolation.

It is the first oral medication approved by the FDA, aside from an intravenous injection authorized in 2019. The injection process required patients to stay two and a half days in the hospital.

The trial's participants were pregnant women with PPD whose symptoms began in the third trimester or within four weeks after birth and who met the DSM-IV criteria for a major depressive episode.

For 14 days, participants in Study one received a 50 mg dose of Zurzuvae or a placebo once daily in the evening. In Study two, participants were given a placebo or a different zuranolone substance that was equivalent to 40 mg of Zurzuvae for 14 days. Following the 14-day treatment, patients in both studies were observed for at least four weeks.

The primary endpoint of all studies was the change in depressive symptoms using the total score from the 17-item Hamilton depression rating scale (HAMD-17), measured on day 15.

Patients in the Zurzuvae groups showed a marked improvement in their symptomatology compared to those in the placebo groups. On Day 42, four weeks following the last dosage of Zurzuvae, the therapeutic impact was still apparent.

What is postpartum depression (PPD)?

Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness — even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child's physical and emotional development.

- Tiffany R. Farchione, Director of the Division of Psychiatry at FDA

She said that for many of these women dealing with intense, occasionally life-threatening emotions, having access to oral medicine will be a phelpful alternative.

PPD is marked by melancholy, a lack of interest in once-loved hobbies, and a decreased aptitude for enjoyment, much like other types of depression. A few signs include cognitive impairment, inadequate or hopeless feelings, weariness, or even suicidal thoughts.

As postpartum depression can lead to other serious illnesses, it is crucial to seek appropriate help. Zurzuvae successfully treats PPD in adults, according to two randomized, double-masked, placebo-controlled, multi center studies.

What are some adverse effects of the oral pill?

Drowsiness, dizziness, diarrhea, weariness, nasopharyngitis, and urinary tract infection are the most prevalent adverse effects of the postpartum depression pill. Zurzuvae usage may result in suicidal thoughts and conduct. It also has the potential to damage a fetus. Women should utilize effective contraception while taking Zurzuvae and for one week afterward.

According to the labeling, Zurzuvae can impair a person's ability to drive and conduct other potentially dangerous tasks. Those taking the pill may also be unable to judge their level of impairment.

The agency advises patients not to go or operate heavy machinery for at least 12 hours after taking Zurzuvae to limit the risk of damage.