The Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) from Heron Therapeutics for HTX-011, a long-acting, fixed-dose combination of the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug meloxicam, for postoperative pain management.
The Company had initially submitted the NDA back in October 2018, however the FDA had issued a Complete Response Letter requesting additional information regarding chemistry, manufacturing, and controls; issues relating to clinical efficacy or safety were not noted in the CRL.
The NDA, which was resubmitted in September 2019, includes data from 7 clinical studies involving 5 bony and soft tissue procedures involving ≥1000 patients. “The recently reported topline results from Study 306 in patients undergoing knee replacement surgery who received HTX-011 as part of a common multimodal analgesic regimen showed that patients maintained an average pain score in the mild range for 72 hours after surgery with only 25% receiving a prescription for opioids upon hospital discharge,” said Barry Quart, PharmD, President and Chief Executive Officer of Heron. “These results provide additional evidence that even in large painful surgical procedures HTX-011 can help to reduce both pain and the amount of opioid pills going out into society.”
HTX-011 was previously granted Breakthrough and Fast Track designations by the FDA. The treatment is designed to deliver pain relief directly to the site of tissue injury, thereby potentially reducing the need for systemically-administered pain medications. A Prescription Drug User Fee Act (PDUFA) date of March 26, 2020 has been set for the NDA.
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