FDA approves first pill to treat postnatal depression in US women

The Food and Drug Administration (FDA) has given approval for the zuranolone to be used as a pill to treat postnatal depression becoming a potential alternative to the only existing treatment done through intravenous injection.

The drug which is sold under the brand name Zurzuvae has been advised by the FDA to be taken by patients as a once-daily pill for two weeks and, according to drug manufacturers Sage Therapeutics and Biogen, the pill is expected to be available later this year.

However, no price has been announced officially.

The FDA suggests that postnatal depression or postpartum depression (PPD) can be similar to other forms of clinical depression as its symptoms can include sadness, loss of energy, suicidal thoughts, decreased ability to feel pleasure or cognitive impairment.

According to research, one in seven women in the US experience symptoms of postnatal depression.

"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," said Tiffany Farchione, head of psychiatry in the FDA's Center for Drug Evaluation and Research.

"And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child's physical and emotional development.

"Access to oral medication will be beneficial for many women "coping with extreme, and sometimes life-threatening, feelings", she added.

Based on clinical trials, Zurzuvae significantly reduced depressive symptoms within three days, with the FDA stating that the medication maintained its effect four weeks after the last dose.

Meanwhile, common side effects of the drug include drowsiness, dizziness, diarrhoea, fatigue, the common cold, and urinary tract infection, the BBC reported.

Additionally, the agency warned that patients of postnatal depression should not drive or operate heavy machinery for at least 12 hours after taking it and said that the drug's labelling features a boxed warning which also notes that Zurzuvae can affect a person's ability to drive and perform other potentially hazardous activities.

Sage Therapeutics and Biogen sought approval for zuranolone for major depressive disorder (MDD), but the FDA rejected the medication's effectiveness due to insufficient evidence.

While the companies are evaluating their next steps, Sage Therapeutic said that it was "highly disappointed for patients, particularly amid the current mental health crisis and millions of people with MDD struggling to find symptom relief."