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Heron resubmits application to US FDA seeking approval of non-opioid pain drug

Heron Therapeutics Inc. said it refiled an application with the U.S. Food and Drug Administration seeking approval of its non-opioid pain drug HTX-011 following an initial rejection in April.

The San Diego-based biotechnology company's latest application contains additional nonclinical information as requested by the U.S. regulator to review the medicine.

Heron President and CEO Barry Quart said the medicine has the potential to be a new pain management option that can reduce the need for opioids. The company expects a six-month review period by the FDA.

HTX-011 is a formulation of local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for managing post-operative pain.

HTX-011 — which is under review by the European Medicines Agency — in combination with certain painkillers has shown to help patients recover without opioids after undergoing hernia repair surgery.