Acadia Pharmaceuticals Announces Top-Line Results from Phase 2 Study Evaluating ACP-044 for the Treatment of Acute Postoperative Pain
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.
“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
Most 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.
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.
About Phase 2 Proof-of-Concept Bunionectomy Study
The 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 Scale (NRS), which scores pain on a scale of 0-10.
ACP-044 is a non-opioid, novel, first in class, redox modulator investigational drug in development for the treatment of acute and chronic pain.1 ACP-044 is an orally bioavailable small molecule with minimal brain distribution that is believed to function as a redox modulator of reactive oxygen species such as peroxynitrite. Reactive oxygen species arise from tissue injury and inflammation and are thought to intensify pain through a variety of different pathways.2,3,4,5,6 ACP-044’s mechanism of action is believed to modulate redox pathways involved in pain signaling by reducing increased levels of reactive oxygen and nitrogen species such as peroxynitrite.1 Downstream effects of increased reactive oxygen and nitrogen species levels may result in peripheral and central nerve sensitization, cytotoxicity, inflammation, and pain.2,3,4,7 Redox modulation represents a novel and promising approach to acute and chronic pain management. 2,3,4,5,6
About Acute Postoperative Pain
Pain is a major healthcare issue, with high prevalence, significant patient burden and substantial economic impact.8 A high unmet need remains in postoperative pain with more than 50 million surgical cases in the
Currently, opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are the leading treatment options for acute postoperative pain.11 Opioid overdose is the leading cause of death in the
Acadia is advancing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson’s disease psychosis. Our late-stage development efforts are focused on treating psychosis in patients with dementia, the negative symptoms of schizophrenia and Rett syndrome. Our early-stage development efforts are focused on novel approaches to pain management, cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn and Twitter.
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia’s annual report on Form 10-K for the year ended
1 Acadia. Data on file. 2021.
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9 ORManager.com; Can your hospital survive ASC,
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