The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zynrelef (bupivacaine and meloxicam), from Heron Therapeutics, intended for the treatment of post-operative pain.
Zynrelef will be available as prolonged-release wound solutions (60 mg / 1.8 mg, 200 mg / 6 mg and 400 mg / 12 mg). Bupivacaine works as a local anaesthetic and meloxicam enhances the efficacy of bupivacaine. The benefits with Zynrelef are its ability to relieve post-operative pain. The most common side effect was dizziness.
Comment: In June 2020, Heron Therapeutics received a Complete Response Letter from the FDA regarding its New Drug Application (NDA) for HTX 011 for the management of postoperative pain. The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues or CMC issues.