FDA rejects Heron's opioid alternative for pain over CMC issues

FDA Building
The FDA has issued a complete response letter for Heron Therapeutics' pain drug candidate that offers an alternative to using opioids. (FDA)

Heron Therapeutics’ pain drug candidate got both a breakthrough designation and a priority review that hastened FDA consideration. No surprise, given the FDA’s urgency to find alternatives to opioids for treating pain. But sometimes speed can cause delays, such as a complete response letter tied to questions that might have been answered if the FDA had more time.

The San Diego-based drugmaker Wednesday announced it had received a complete response letter asking for additional chemistry manufacturing and controls info. CEO Barry Quart in a call with investors emphasized the agency did not identify any clinical safety or efficacy issues for what is still called HTX-011.

But the CEO did say the company was “extraordinary disappointed” that the issues, which Heron believes are easily addressed, were not resolved during the six-month priority review period. He said the company will seek a meeting with the FDA and resubmit its NDA as soon as possible.

“I can't speak for the FDA. The only thing I can obviously point to is this is a very fast review period,” Quart said in response to an analyst’s question about why, if the issues are small, they weren’t addressed in the review.  “I don't think that is good excuse but that is the only explanation that I have. Obviously we will make our displeasure known when asking for them to be quick about timing of a follow-up meeting and review of what should be a very small amount of information,” the CEO said.   

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HTX-011 is a long-acting formulation of bupivacaine solution combined with the anti-inflammatory medication meloxicam. In several trials, the drug significantly reduced pain intensity and decreased opioid use for 72 hours after surgery.

The drug is administered using the company’s proprietary biochronomer delivery technology, which the company also uses in its two approved injectable therapies, Sustol and Cinvanti, each of which address one of the primary mechanisms of chemo-induced nausea and vomiting.

Heron's stock closed Wednesday down more than 18%, while shares at Pacira Biosciences, whose pain treatment Exparel would be challenged by the Heron drug, were up 14%. 

Heron’s issues came on the same day another company, Nabriva, announced that it received an FDA complete response letter for its new infection fighter Contempo because of issues related to one of its contract manufacturers.