It took a few years and three tries, but Heron Therapeutics Inc. finally got its pain drug, HTX-011, now branded Zynrelef, over the FDA finish line. Even so, the approval comes with a less broad label than Heron would have liked. Zynrelef (bupivacaine and meloxicam), which had a May 12 PDUFA date, is approved for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.
The FDA came through at last for Athlone, Ireland-based Innocoll Holdings Ltd., greenlighting the drug-device combo Xaracoll (bupivacaine HCl) for acute postsurgical pain relief for up to 24 hours in adults after open inguinal hernia repair.