FDA rejects Heron's non-opioid painkiller

Shares in US biotech Heron Therapeutics were sharply down yesterday after the FDA rejected its post-operative painkiller, saying additional manufacturing and non-clinical information is needed to approve it.

In a statement the San Diego biotech said that the FDA had issued a dreaded Complete Response Letter (CRL) for HTX-011, a long-acting extended-release formulation of the local anaesthetic bupivacaine, in a fixed-dose combination with the anti-inflammatory drug meloxicam.

The formulation works by delivering sustained levels of a potent anaesthetic and a local anti-inflammatory agent directly to the site of tissue injury after an operation.

The rejection comes at a time when the FDA is trying to find alternatives to potentially addictive and lethal opioids, implicated in the deaths of tens of thousands of Americans as a result of over-prescription and illegal supply.

HTX-011 has been designed to deliver better pain relief while reducing the need for painkillers and their potentially risky side-effects.

According to Heron, the FDA said in its rejection letter that it is unable to approve HTX-011 in its present form and needs additional Chemistry, Manufacturing and Controls (CMC) and non-clinical information.

However the FDA did not identify any clinical safety or efficacy issues, and required no further expensive and time-consuming clinical studies or data analyses.

Last year, Heron released data for HTX-011 showing it hit all primary and key secondary endpoints in two phase 3 trials, which cut requirements for opioids to treat pain.

The FDA had even granted a priority review for the drug, lasting only six months instead of the standard 10 months, and had given it Breakthrough Designation indicating it could be a significant improvement over previously-approved drugs.

In the past, manufacturers have managed to resolve such matters fairly quickly, and while Heron has given no timeline for how long talks with the FDA will take, it looks unlikely that the drug will be on the market this year.

Barry Quart, president and CEO of Heron Therapeutics, said: "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 (filing) as soon as possible.”

Shares in Heron were down 18% on the Nasdaq at close of trade following the announcement.