Acacia Pharma announces positive Phase 3 results with APD421 for the management of post-operative nausea & vomiting (PONV). The data generated demonstrated a statistically significant reduction in the incidence of PONV with APD421 compared to placebo in adult surgical patients at moderate to high risk of suffering PONV (PONV is defined as any episode of emesis or use of antiemetic rescue medication in the first 24 hours after surgery). This condition is a clinically significant problem despite the availability of a range of antiemetic medications. In particular, there remains a clear need for improved options for combination prophylaxis in the highest risk patients, and rescue therapy.
Two double-blind, placebo controlled, Phase 3 studies were conducted in 19 major centres in the US, France and Germany, and recruited a total of 689 surgical patients with two or more of the four validated "Apfel risk factors" for PONV, of whom 626 were evaluable per protocol. APD421 was significantly superior to placebo (p=0.005), giving a relative risk reduction (RRR) of 19.4% in the incidence of PONV. There was no significant difference in the rate of adverse events between APD421 and placebo. Detailed data from these studies will be presented at an upcoming scientific meeting and/or submitted for publication in a peer-reviewed journal.
Acacia Pharma's CEO, Dr Julian Gilbert, commented: "A significant number of patients suffer from PONV despite routine use of prophylactic antiemetics, predominantly 5HT3s and corticosteroids, increasing healthcare costs and reducing patient satisfaction. There is a clear need for an efficacious, safe antiemetic with a different mechanism of action for use in combination prophylaxis in the highest risk patients, and to rescue patients who suffer PONV despite receiving prophylaxis. Our clinical data indicate APD421 is an effective dopamine antagonist antiemetic, which has the potential to become a mainstay of therapy, contributing greatly to the well-being of patients following surgery."
Dr Gabriel Fox, Acacia Pharma's CMO, added: "Dopamine antagonists were a popular and very efficacious option for anaesthetists seeking to prevent PONV, until the emergence of safety concerns such as heart rhythm disturbances and movement disorders. Acacia Pharma set out to develop an effective and safe dopamine antagonist to add back into the armamentarium of antiemetics for the management of PONV. We believe we are on the way to achieving this goal, having completed three studies with many of the world's leading experts in PONV, providing statistically significant evidence of the benefit of APD421 in PONV without the safety issues previously seen with this class of drugs."
The company has engaged J.P. Morgan Cazenove to advise the Board on its strategic options.
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