Sage Therapeutics has secured the US Food and Drug Administration (FDA) approval for its Zulresso (brexanolone) injection to treat postpartum depression (PPD).
PPD is known to affect one in nine women. Despite being termed postpartum, symptoms sometimes begin during pregnancy as well as after childbirth. The condition is characterised by sadness and anxiety, with many patients reporting thoughts of self harm and trouble bonding with their babies.
Existing treatments include standard antidepressants, psychotherapy and even shock therapy.
Zulresso is the first FDA-approved drug specific for PPD. The medicine is an allosteric modulator of synaptic and extrasynaptic GABAA receptors. Allosteric modulation results in various degrees of desired activity rather than a complete activation or inhibition of the targeted receptors.
Sage Therapeutics CEO Jeff Jonas said: “Not only do we believe Zulresso will address an important need for women’s mental health, the impact of PPD is multi-generational, and we look forward to bringing Zulresso to patients in urgent need of a new treatment option.”
“We believe ZULRESSO will be a catalyst in starting a new dialogue emphasizing the importance of women’s mental health, and the importance of diagnosing and treating PPD.”
The FDA approval comes after review of findings from three clinical trials that assessed the safety and effectiveness of the drug in moderate to severe PPD patients aged 18 and 45 years.
Data from all the three trials showed that all doses of Zulresso met the primary endpoint with a significant mean decrease in the Hamilton Rating Scale for Depression (HAM-D) total score from baseline, compared to placebo, at 60 hours.
The improvement in depression symptoms was maintained till the end of the 30-day follow-up period. The most common adverse events in the trials were sleepiness, dry mouth, loss of consciousness and flushing.
Due to serious risks, such as excessive sedation or sudden loss of consciousness, associated with the drug, it will be made available through a restricted distribution programme that requires monitoring of patient at certified health care facilities.
The drug is expected to be commercially launched in June this year.
According to Reuters, the company would list price the product at $7,450 per vial, which could lead to a projected average cost of $34,000 per patient before discounts.