Industry Briefs

Postpartum Depression Therapy Receives FDA Breakthrough Designation

Earlier this month, SAGE Therapeutics announced that its investigational drug for postpartum depression, SAGE-547, a GABAA modulator delivered intravenously, has been granted Breakthrough Therapy Designation by the Food and Drug Administration (FDA).

The FDA’s decision was based primarily on phase 2 studies with 21 patients who experienced severe postpartum depression within four weeks of delivery. Women taking the medication intravenously were found to have a significant reduction in their Hamilton Rating Scale for Depression scores compared with women administered placebo.

The effect of SAGE-547 was maintained through a 30-day follow-up period, and the medication was generally well tolerated.

FDA Approves Computerized Devices to Detect Head Injury–Related Cognitive Impairment

Last month, the FDA approved two computerized devices that are intended to assess cognitive function following a suspected brain injury or concussion. The devices—named the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric—are the first of their kind to be approved by the FDA.

The approval of ImPACT and ImPACT Pediatric was based on 250 peer-reviewed manuscripts that supported the validity and reliability of the devices, as well as their ability to detect evidence of cognitive dysfunction that might be associated with a concussive head injury. The devices are not meant to diagnose concussions or determine appropriate treatments, but rather to assess cognitive skills such as word memory, reaction time, and word recognition. Patients’ scores are compared with those from an aged-match control database or the patients’ pre-injury baseline scores, if available. ■