Heron Therapeutics (HRTX) Resubmits NDA to FDA for HTX-011 for Treatment of Postoperative Pain

November 13, 2020 8:33 AM EST

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Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain.

The NDA for HTX-011 was resubmitted based on the outcome and final minutes of a Type A End-of-Review meeting with the FDA in September, which was conducted to obtain clarity on the information needed to address the Complete Response Letter (CRL) issued by the FDA in June 2020. The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information. There are four non-clinical issues in the CRL, 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. Since receiving the CRL, Heron generated data showing that peak plasma levels (Cmax) of excipients in reproductive toxicology studies are >50- to >200-fold higher than the levels observed in patients receiving the highest dose of HTX-011. These results provide validation of the previously submitted animal studies. At the Type A End-of-Review meeting in September, the FDA agreed with the change to the manufacturing specification proposed by Heron to address their concern. The FDA indicated at the Type A End-of-Review meeting that the submission will be classified as a Class 2 resubmission, which means that the FDA can take up to 6 months to review the new information included in the NDA resubmission.

"We are pleased to have resubmitted the NDA for HTX-011, which we believe fully addresses the CRL based on advice from the FDA," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "In our resubmission, we provided compelling evidence responding to the issues identified in the CRL that should provide the basis for the approval of the HTX-011 NDA. Heron remains committed to bringing HTX-011 to patients and we look forward to working with the FDA to achieve this goal."



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