New Drug Application Accepted for Combined Bupivacaine/Meloxicam for Post-Operative Pain


The Food and Drug Administration (FDA) has accepted a new drug application (NDA) for fixed-dose combined bupivacaine/meloxicam (HTX-011; Heron Therapeutics, San Diego, CA), an investigational, extended-release nonopioid drug for management of postoperative pain combining a combination of the local anesthetic bupivacaine and the anti-inflammatory meloxicam. The FDA has granted priority review status for this NDA

The NDA for HTX-011 was submitted in October 2018 and contains data from both phase 2 and phase 3 clinical trials that included more than 1,000 patients who had 1 of 5 types of surgical procedures: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty, or breast augmentation.  Combined bupivacaine/meloxicam reduced pain significantly better than placebo or bupivacaine alone while reducing the need for opioids and an overall safety profile similar to bupivacaine solution, without evidence of meloxicam-related toxicities. 

"We are pleased to receive priority review designation for the HTX-011 NDA," said Barry D. Quart, PharmD, chief executive officer of Heron Therapeutics. "We believe that HTX-011 could have a considerable impact on the lives of patients by significantly reducing the proportion of patients who experience severe pain and receive opioids after surgery, especially at discharge. We look forward to continuing to work closely with the FDA during the review process with the goal of bringing this important product to patients in 2019."

"Despite ongoing efforts to prevent opioid abuse, patients continue to receive large quantities of opioids for postsurgical pain," said Jay Redan, MD, FACS, Medical Director of Minimally-Invasive General Surgery at Florida Hospital Celebration Health. "There is a significant need for safe, effective and nonaddictive options that can decrease opioid exposure and improve the patient recovery experience, as well as make an impact on the opioid epidemic by significantly reducing the amount of opioids necessary to take home for pain management."


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