Heron Therapeutics announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on April 30, 2019 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 CMC and non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues, and there is no requirement for further clinical studies or data analyses.
"We plan to request a meeting with the FDA to obtain its agreement on our approach to resolve the issues outlined in the CRL and resubmit the NDA as soon as possible," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics.
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HTX-011, which utilizes Heron's proprietary Biochronomer® drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine solution in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, and total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the FDA in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted an NDA to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December of 2018. A CRL was received from the FDA regarding the NDA for HTX-011 on April 30, 2019. An MAA for HTX-011 was validated by the EMA in March 2019 for review under the Centralised Procedure.