FDA Relents, Approves Novel Antidepressant After Many Rejections
After multiple prior rejections, gepirone hydrochloride extended-release (ER; Exxua) gained FDA approval for the treatment of major depressive disorder (MDD) in adults, drugmaker Fabre-Kramer Pharmaceuticals announced. Gepirone ER is the first approved antidepressant that selectively targets the serotonin 1A receptor, which regulates mood and emotion. The drug was approved based on data from two 8-week […]
FDA Mulling Trial Design Issues for Long-Term Opioids in Chronic Pain
To evaluate the long-term efficacy and tolerability of a representative extended-release (ER)/long-acting (LA) opioid in a 12-month placebo-controlled trial, FDA staff are considering an enriched enrollment randomized withdrawal (EERW) study design, they noted in a briefing document ahead of an advisory committee meeting. On Wednesday, the Anesthetic and Analgesic Drug Products Advisory Committee will consider […]