Heron Therapeutics Inc. has received a complete response letter from the FDA for HTX-011 for the management of postoperative pain, according to a company press release.
The FDA was unable to approve the new drug application and issued the complete response letter on the need for additional chemistry manufacturing and control and non-clinical information. The FDA found no clinical safety or efficacy issues and there is no requirement for further clinical studies or data analyses, according to the release.
“We are committed to resolving the non-clinical issues outlined in the CRL [complete response letter] with the FDA and resubmitting an NDA as soon as possible to bring this important non-opioid analgesic to patients,” Barry Quart, PharmD, president and CEO of Heron Therapeutics, said in the release.
HTX-011 is an investigational non-opioid that delivers an extended-release formulation of bupivacaine with meloxicam. The company will request a meeting with the FDA to obtain agreement on their approach as soon as possible, according to the release.