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news.Acacia Pharma has reported positive results from its Phase II study of APD421 in post-operative nausea and vomiting (PONV).
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The study demonstrated that PD421 significantly reduced the incidence of nausea and vomiting compared to placebo in adult surgical patients.
Acacia CEO Julian Gilbert said anaesthetists seek a safe dopamine antagonist for the prevention and treatment of PONV and APD421 appears to meet this profile.
"We therefore believe that it has the potential to become a mainstay of anti-emetic therapy and contribute greatly to the well-being of patients undergoing surgery," Gilbert added.
The double-blind study, comparing three doses of APD421 with placebo, recruited 223 surgical patients with two or more of the four established Apfel risk factors for PONV.
The primary endpoint was protection against PONV, defined as no vomiting or retching and no requirement for anti-emetic rescue medication in the first 24 hours after surgery, the company said.
APD421 was very well tolerated at all dose levels, with no significant difference in the frequency of any adverse event for any dose of APD421 compared to placebo.