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Acadia Pharmaceuticals Announces Top-Line Results from Phase 2 Study Evaluating ACP-044 for the Treatment of Acute Postoperative Pain
SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line results from a Phase 2 randomized, double-blind,
About this update from Acadia Pharmaceuticals Inc.
[{"type":"text","content":" SAN DIEGO--(BUSINESS WIRE)--\nAcadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line results from a Phase 2 randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of ACP-044 for acute pain following bunionectomy surgery. The primary endpoint, a comparison of cumulative pain intensity scores over 24 hours between the ACP-044 1600 mg once daily, ACP-044 400 mg four times daily and placebo treatment arms, was not met.\n\nA trend favoring the ACP-044 400 mg once every six hours treatment group was observed on the primary endpoint, a difference of -10.5 points compared to placebo (p = 0.1683; effect size = 0.219). These numerical trends were consistently better than placebo, but not statistically significant, at 48 hours and 72 hours.\n\n“We are disappointed that the ACP-044 bunionectomy study did not meet its primary endpoint, especially given the significant need for novel, non-opioid treatment options for postsurgical pain. We will continue to analyze the totality of the data to best determine whether further development in acute pain is appropriate,” said Steve Davis, Chief Executive Officer. “We’d like to thank the study participants as well as the investigators and staff who contributed to this study.”\n\nMost adverse events were mild-to-moderate and there were no serious adverse events related to ACP-044. Fewer patients discontinued treatment in the ACP-044 arms than in the placebo group.\n\nAcadia is currently evaluating ACP-044 in an ongoing study in osteoarthritis, a model of chronic pain, which is expected to complete in the first half of 2023.\n\nAbout Phase 2 Proof-of-Concept Bunionectomy Study\n\nThe Phase 2 clinical trial design, evaluating the safety and efficacy of the investigational drug ACP-044 for the treatment of acute postoperative pain following orthopedic surgery (bunionectomy), was a multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical trial involving 239 patients undergoing bunion removal on one foot. Patients were randomized to one of the following three groups: 1600 mg of ACP-044 administered once daily (n=78), 400 mg every six hours (n=81), or placebo (n=80). Patients were first dosed prior to surgery and continued treatment for a total of four days. Patients self-reported their pain intensity using the Numeric Rating Sca...