Therapy Areas: Central Nervous System
Acadia Pharmaceuticals Posts Top-Line Results from Phase 2 Study Evaluating ACP-044 for the Treatment of Acute Postoperative Pain
20 April 2022 - - US-based Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) has provided 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 company said.

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.

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.

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, 400 mg every six hours, or placebo.

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, 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.

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.

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.

Downstream effects of increased reactive oxygen and nitrogen species levels may result in peripheral and central nerve sensitization, cytotoxicity, inflammation, and pain.

Redox modulation represents a novel and promising approach to acute and chronic pain management. 

Pain is a major healthcare issue, with high prevalence, significant patient burden and substantial economic impact.

A high unmet need remains in postoperative pain with more than 50m surgical cases in the US annually and approximately 75% of patients reporting postoperative pain as moderate, severe, or extreme.

Currently, opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are the leading treatment options for acute postoperative pain.

Opioid overdose is the leading cause of death in the US for people aged 18 to 45 years and in 2021, led to an average of 128 overdose deaths each day, per CDC estimates.

As such, there is a great need for additional effective and safe treatment options as part of a multimodal treatment strategy.

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.

The company has developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson's disease psychosis.

Its late-stage development efforts are focused on treating psychosis in patients with dementia, the negative symptoms of schizophrenia and Rett syndrome.

Acadia's early-stage development efforts are focused on novel approaches to pain management, cognition and neuropsychiatric symptoms in central nervous system disorders.
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