FDA Requests More Non-Clinical Information for HTX-011

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Heron Therapeutics for the New Drug Application (NDA) of HTX-011 for the management of postoperative pain.

HTX-011 is an investigational non-opioid, dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam.

The drug represents the first and only extended-release local anesthetic to demonstrate on phase 3 studies to significantly reduce pain and opioid use through 72 hours compared to a bupivacaine solution.

In the letter, the FDA states they are unable to approve the drug application based on the need for additional non-clinical data.

However, the agency did not identify any clinical safety or efficacy issues or CMC issues with the new drug.

There are currently 4 non-clinical problems outlined in the letter, none of which relate to any observed toxicity with 3 relating to confirming exposure of excipients in preclinical reproductive toxicology studies.

The fourth issue relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage.

The FDA does not believe any of the issues represent significant barriers that would prevent an eventual approval because all of the excipients have extensive histories of use in pharmaceuticals and the specification can be revised.

Heron is expected to request a Type A meeting to obtain an agreement with the FDA and resubmit the NDA.

"We are committed to resolving the non-clinical issues outlined in the CRL with the FDA and resubmitting an NDA as soon as possible to bring this important non-opioid analgesic to patients," Barry Quart, Pharm.D., President and Chief Executive Officer of Heron, said in a statement.