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Heron Therapeutics Announces Initiation of Phase 3 Program for HTX-011 in Postoperative Pain Following Successful End-of-Phase 2 Meeting with FDA

SAN DIEGO--(BUSINESS WIRE)--Heron Therapeutics, Inc. (Nasdaq: HRTX) (the Company or Heron), a commercial-stage biotechnology company focused on developing novel, best-in-class treatments to address some of the most important unmet patient needs, today announced the positive outcome of a recent End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding the Company’s investigational agent, HTX-011, to prevent postoperative pain for the first 72 hours after surgery.

“We are pleased to announce the positive outcome of the End-of-Phase 2 meeting for HTX-011 and the recent initiation of patient enrollment in our Phase 3 program”

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General agreement was reached with the FDA on the design and key elements for HTX-011’s Phase 3 program that will be required to support a New Drug Application (NDA). The program includes two pivotal Phase 3 efficacy studies in bunionectomy and hernia repair, representing a bony model and a soft tissue model, respectively.

Heron recently initiated patient enrollment in the HTX-011 Phase 3 program and anticipates completing the Phase 3 program in the first half of 2018. Heron expects to file an NDA for HTX-011 in 2018.

The Phase 3 program is designed to achieve a broad indication for the reduction in postoperative pain for 72 hours following surgery. The primary endpoints of the Phase 3 efficacy studies will be the difference in mean area under the curve (AUC) of pain intensity scores through 72 hours compared with placebo. The first key secondary endpoints will be the difference in mean AUC of pain intensity scores through 72 hours compared with bupivacaine. Additional key secondary endpoints measuring reduction in opioid use and proportion of subjects who are opioid-free are included to support an opioid-sparing claim. In addition to the Phase 3 efficacy studies, approximately 200 patients will be enrolled in a Phase 3 safety and pharmacokinetics study to meet the target patient numbers established by the FDA and to provide further evidence of the broad utility of HTX-011 across multiple surgical models. Importantly, the FDA noted that, beyond the agreed-upon Phase 3 studies, no additional clinical work is needed to meet the “Combination Rule” for fixed-dose combination products.

“Inadequate pain management during the first 72 hours following surgery may lead to chronic post-surgical pain and an increased risk of opioid addiction. This places a greater economic burden on the healthcare system, and it potentially results in millions of opioids flooding our communities,” said Harold S. Minkowitz, MD, Diplomat American Board of Anesthesiology, Department of Anesthesiology, Memorial Hermann...