Heron Therapeutics has received a complete response letter (CRL) from the FDA for its painkiller combining two non-opioid therapeutics.
The long-acting treatment, HTX-011, combines bupivacaine, a local anesthetic, and meloxicam, a nonsteroidal anti-inflammatory. Last year, the FDA rejected Heron’s first application for the therapy, citing manufacturing chemistry concerns and other issues. This time around, Heron says the agency has raised questions about other non-clinical issues.
Of the four questions raised by the FDA, Heron said in a statement that “three relate to confirming exposure of excipients in preclinical reproductive toxicology studies, and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage.”
Because the active ingredients used in the treatment have already been approved by the FDA, Heron expressed confidence that the new CRL will not prevent HTX-011 from ultimately winning approval.
