HTX-011 (bupivacaine and meloxicam) is an investigational drug that has not been approved by the FDA or other international regulatory authority. HTX-011 is an extended release dual-acting local anesthetic (DALA) and is a fixed-dose combination of the local anesthetic bupivacaine with the nonsteroidal anti-inflammatory drug (NSAID) meloxicam. Inclusion of low-dose meloxicam in HTX-011 reduces local inflammation which reverses the acidic environment caused by surgery, allowing enhanced penetration of bupivacaine into the nerves and thereby potentiating bupivacaine’s effect. HTX-011 is in development for application into the surgical site to reduce postoperative pain and the need for opioid analgesics for 72 hours. It was granted Fast Track Designation from the FDA in the fourth quarter of 2017 and Breakthrough Therapy Designation from the FDA in the second quarter of 2018. Positive Phase 3 Results for HTX-011 from the EPOCH 1 study (bunionectomy) and EPOCH 2 study (hernia repair) have been published in peer-reviewed scientific journals, and positive topline Phase 2b Results for HTX-011 in subjects undergoing total knee arthroplasty and breast augmentation have been released. A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry, manufacturing, and controls and non-clinical information. No issues related to clinical efficacy or safety were noted. The NDA for HTX-011 was resubmitted in September 2019 based on the outcome and final minutes of a Type A meeting with the FDA, which was conducted to obtain clarity on the CRL.
A Marketing Authorisation Application for HTX-011 was validated by the European Medicines Agency in March 2019 for review under the Centralised Procedure.