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Pharmaceuticals / Regulatory Affairs

Heron Therapeutics Takes Shot at FDA After CRL Stalls Anti-Pain Treatment

May 8, 2019
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Heron Therapeutics said the company was sandbagged by federal regulators who issued a complete response letter for its experimental anti-pain medicine.

The FDA flagged concerns over Heron’s supply chain for the candidate drug HTX-011, an extended-release combination of the local anesthetic bupivacair and the anti-inflammatory meloxicam, designed to treat patients coming out of surgery.

“We believe that all of the issues raised could have been resolved during the review had we been given the chance to discuss them with the FDA. Unfortunately, the FDA did not provide us with the opportunity due to the rapid nature of a priority review,” Heron President and CEO Barry D. Quart said. “It’s very discouraging.”

The letter is a blow to Heron because HTX-011 is its only drug candidate in clinical trials. A separate pain candidate, HTX-034, is at the pre-clinical stage.

An FDA spokesperson declined to comment, citing FDA policy not to discuss pending applications.

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