- Acadia Pharmaceuticals Inc (NASDAQ:ACAD) announced topline results from a Phase 2 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.
- A 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.
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- "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," said CEO Steve Davis.
- Most adverse events were mild-to-moderate, and there were no serious adverse events related to ACP-044.
- Acadia 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.
- ACP-044 is a non-opioid, redox modulator investigational drug in development to treat acute and chronic pain.
- Price Action: ACAD shares are down 7.72% at $20.68 during the premarket session on the last check Tuesday.
