Heron Therapeutics announces agreement with FDA for HTX-011's Phase 3 program
Heron Therapeutics announced the positive outcome of a recent End-of-Phase 2 meeting with the FDA regarding the Company's investigational agent, HTX-011, to prevent postoperative pain for the first 72 hours after surgery. 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, or 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.