FDA again rebuffs Heron Therapeutics' postoperative pain therapy HTX-011

Shares in Heron Therapeutics plunged up to 32% on Monday after the company reported that the FDA issued a complete response letter (CRL) regarding its resubmitted marketing application for HTX-011 to help manage postoperative pain. Last year, the FDA had rejected the investigational non-opioid drug, which consists of a fixed-dose combination of the local anaesthetic bupivacaine plus the anti-inflammatory meloxicam, with the agency asking for additional chemistry, manufacturing and controls (CMC) and non-clinical information.

The filing included data from the Phase EPOCH1 and EPOCH2 trials showing that HTX-011 had significantly reduced pain and the need of opioids versus bupivacaine following surgery.

Heron noted that the FDA did not identify any clinical safety, efficacy or CMC issues this time around, but has requested more non-clinical information. There are four non-clinical issues cited in the latest CRL, with the company noting that none are tied to any toxicity issues. Specifically, three of the issues relate to confirming exposure of excipients in preclinical reproductive toxicology studies, while the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage.

No 'significant barriers' to approval

The company said it does not consider these issues to be "significant barriers to ultimate approval, as all of the excipients have extensive histories of use in pharmaceuticals and the specification can be revised." Meanwhile, CEO Barry Quart indicated that Heron is looking to resubmit a filing "as soon as possible to bring this…non-opioid analgesic to patients."

HTX-011 was previously granted both breakthrough therapy and fast-track designations by the FDA for use in postoperative pain management.

Meanwhile, Pacira Pharmaceutical's non-opioid drug Exparel (bupivacaine liposome injectable suspension), which is priced at $180.35 for a 10-ml dose and $334.18 for the 20-ml dose, is indicated in the US for single-dose infiltration in adults to produce postsurgical local analgesia. The FDA expanded Exparel's label in 2018 to include administration via interscalene brachial plexus block to produce postsurgical regional analgesia.

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