Date: 2014-10-07
Type of information: Results
phase: 3
Announcement: results
Company: Acacia Pharma (UK)
Product: APD421 (intravenous formulation of a currently marketed dopamine D2 antagonist for the new use of prevention and treatment of nausea & vomiting)
Action mechanism:
Disease: prevention of post-operative nausea & vomiting (PONV)
Therapeutic area: Gastrointestinal diseases - Digestive diseases
Country: France, Germany, USA
Trial
details: The Phase 3 studies are taking place in 19 major centres in France, Germany and the USA. They will recruit a total of 680 surgical patients at moderate to high risk of suffering PONV (patients with two or more of the four established “Apfel” risk factors for PONV). The trials compare the optimal dose of APD421 against placebo, the primary endpoint being no vomiting or retching and no requirement for anti-emetic rescue medication in the first 24 hours after surgery. The incidence and severity of nausea is also being studied. The studies are expected to complete in the first quarter of 2014.
Latest
news: * On October 7, 2014, Acacia Pharma announced 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). 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. The company has engaged J.P. Morgan Cazenove to advise the Board on its strategic options.
* On September 17, 2013, Acacia Pharma, a pharmaceutical company specialising in the development of drugs for supportive care, has announced the initiation of two pivotal Phase 3 studies of APD421 in the prevention of post-operative nausea & vomiting (PONV).
