Brexanolone safe for postpartum depression: US FDA

January 14, 2019 0 By FM

US FDA advisory panel recommended brexanolone (Zulresso) for postpartum depression.

The Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly voted 17-1 in favour of the injectable treatment, brexanolone, which aims to treat major episodes of depression during pregnancy or within four weeks of delivery.

Brexanolone is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor.

The decision came after FDA staff reviewers raising safety concerns over the loss of consciousness in certain patients who were on the treatment.They, however, recommended implementing a risk evaluation and mitigation strategy (REMS) programme to improve the safety of the product.

Brexanolone is administered as a 60-hour intravenous infusion. The drug targets hormonal changes in new mothers, differentiating it as a drug for postpartum depression rather than “regular” depression.

Brexanolone injection has completed Phase 3 clinical development for postpartum depression and a New Drug Application is currently under review with the USFDA.

Brexanolone for the treatment of PPD has been granted Breakthrough Therapy Designation by the FDA and PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA).