Hello and happy hump day, readers. Sage Therapeutics notched a pioneering victory on Tuesday when the Food and Drug Administration (FDA) approved its postpartum depression drug Zulresso. It’s the first ever treatment to be FDA approved for postpartum depression, the most common mental health condition faced by women who have given birth. The agency’s approval of Zulresso, the brand name for a therapy called brexanolone, was widely expected following favorable reviews from an advisory committee. But it doesn’t come without controversy. In fact, as the FDA explains, the drug’s marketing comes with a number of restrictions. “Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient,” wrote the FDA’s Tiffany Farchione in a statement. Zulresso must be administered via IV infusion by a doctor at a health care facility. The whole episode, however, reflects the complexity of developing effective depression treatments; these drug’s efficacy can vary depending on the individual. But Zulresso is also the second novel medication for a depression-associated disorder in the past few weeks. Earlier this month, the FDA approved Johnson & Johnson’s nasal spray for a version of ketamine to treat serious depression. That’s a different kind of disorder from the postpartum kind (with a significantly different action mechanism)—but the agency appears ready, and willing, to spur ahead treatments in a difficult field. Read on for the day’s news. |