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Antiemetic Drug APD421 Shows Promise in Postoperative Setting
Positive findings have been announced from a phase III study of APD421, an investigational dopamine antagonist antiemetic, in the management of postoperative nausea and vomiting (PONV).
The new data demonstrated a statistically significant reduction in the incidence of PONV after treatment with APD421 compared with placebo in adult surgery patients at moderate to high risk of PONV (defined as any episode of emesis or the 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 need for improved options for combination prophylaxis in the highest risk patients, as well as rescue therapy.
Two double-blind, placebo-controlled, phase III trials were conducted in the U.S., France, and Germany. The studies recruited a total of 689 surgical patients with two or more of the four validated Apfel risk factors for PONV. Of these patients, 626 were evaluable per protocol.
APD421 was shown to be significantly superior to placebo (P = 0.005), providing a relative risk reduction of 19.4% in the incidence of PONV. There was no significant difference in the rate of adverse events between APD421 and placebo.
According to the drug’s developer (Acacia Pharma), APD421 was designed to avoid the safety concerns seen with other dopamine antagonists, such as heart-rhythm disturbances and movement disorders.
Source: Acacia Pharma; October 7, 2014.