Acacia Pharma announces positive results from its Phase II study of APD421, in the prevention of post-operative nausea & vomiting (PONV). The study showed that APD421 significantly reduced the incidence of nausea and vomiting compared to placebo in adult surgical patients at moderate-to-high risk of suffering PONV. Vomiting and especially nausea remain a major problem for patients after surgical operations, despite the availability of a number of approved anti-emetics.
APD421 comprises a completely new, patent-protected use of a currently marketed dopamine D2/D3 antagonist for the prevention and treatment of PONV.
The double-blind, Phase II study, comparing three doses of APD421 with placebo, was conducted in ten major centres in France, Germany and the USA, and 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. APD421 was highly significantly superior to placebo at preventing PONV, the optimal dose approximately halving the PONV rate, from 67% in the placebo group to 36%>
APD421 was very well tolerated at all three dose levels, with no significant difference in the frequency of any adverse event for any dose of APD421 compared to placebo, and no serious adverse reactions. No prolongation of the QT interval was seen with APD421 nor was there any evidence of sedation, psychological symptoms, extrapyramidal toxicity or gastrointestinal disturbance, a clear advantage over many other anti-emetics.
Acacia Pharma's CEO, Dr Julian Gilbert, commented: "We are delighted with these excellent results. 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."
Dr Gabriel Fox, Acacia Pharma's Chief Medical Officer, added: "This was a robust, well-conducted trial in leading European and US centres and has shown an unequivocal benefit for APD421 in patients who are the hardest to protect from post-operative sickness, those with multiple Apfel risk factors."