Acadia 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.
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
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.”
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.
About ACP-044
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 U.S. annually and approximately 75% of
patients reporting postoperative pain as moderate, severe, or
extreme. 9,10
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 U.S.
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.
About Acadia Pharmaceuticals
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.
Forward-Looking Statements
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 December 31, 2021 as well as
Acadia’s subsequent filings with the Securities and Exchange
Commission. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
This caution is made under the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. All
forward-looking statements are qualified in their entirety by this
cautionary statement and Acadia undertakes no obligation to revise
or update this press release to reflect events or circumstances
after the date hereof, except as required by law.
1 Acadia. Data on file. 2021. 2 Grace PM, Gaudet AD,
Staikopoulos V, Maier SF, Hutchinson MR, et al. Nitroxidative
signaling mechanisms in pathological pain. Trends Neurosci.
2016;39:862-879. 3 Zahan OM, Serban O, Gharman C, Fodor D. The
evaluation of oxidative stress in osteoarthritis. Med Pharm Rep.
2020;93:12-22. 4 Fraunbeger EA, Scola G, Laliberte VLM, Duong A,
Andreazza AC. Redox modulations, antioxidants, and neuropsychiatric
disorders. Oxid Med Cell Longev. 2016;2016:4729192. 5 Janes K,
Neumann WL, Salvemini D. Anti-superoxide and anti-peroxynitrite
strategies in pain suppression. Biochim Biophys Acta.
2012;1822:815-821. 6 Little JW, Doyle T, Salvemini D. Reactive
nitroxidative species and nociceptive processing: determining the
roles for nitric oxide, superoxide, and peroxynitrite in pain.
Amino Acids. 2012;42:75-94. 7 Rosenberger DC, Blechschmidt V,
Timmerman H, Wolff A, Treede RD. Challenges of neuropathic pain:
focus on diabetic neuropathy. J Neur Transmis. 2020;127:589-624. 8
Duenas M, Ojeda B, Salazar A, Mico JA, Faille I. A review of
chronic pain impact on patients, their social environment and the
health care system. J Pain Res. 2016;9:457-467. 9 ORManager.com;
Can your hospital survive ASC, Aug 2020;
https://www.ormanager.com/can-hospital-survive-growing-dominance-ascs/
10 Chou R, Gordon et al Management of Postoperative Pain: A
Clinical Practice Guideline J Pain. 2016 Feb;17(2):131-57. doi:
10.1016/j.jpain.2015.12.008. 11 Wilson N, Karise M, Seth P, Smith H
IV, Davis NL. Drug and Opioid-Involved Overdose Deaths — United
States, 2017–2018. Murkily Rep 2020;69:290–297.
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Media Contact: Acadia Pharmaceuticals Inc. Deb Kazenelson (818)
395-3043 media@acadia-pharm.com
Investor Contact: Acadia Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
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