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Positive Phase III data for APD 421 in Nausea-Acacia Pharma

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Last updated:8th Oct 2014
Published:8th Oct 2014
Source: Pharmawand

Acacia Pharma announces positive Phase III results with APD 421 for the management of post-operative Nausea & Vomiting (PONV). The data generated demonstrated a statistically significant reduction in the incidence of PONV with APD 421 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).

Two double-blind, placebo controlled, Phase III 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. APD 421 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 APD 421 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.

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