Date: 2017-02-23
Type of information: Initiation of preclinical development
phase:
Announcement:
Company: Acacia Pharma (UK)
Product: Baremsis™ - APD421 (amisulpride - intravenous formulation of a currently marketed dopamine D2 antagonist for the new use of prevention and treatment of nausea & vomiting)
Action
mechanism: dopamine D2 antagonist.
Disease: post-operative nausea & vomiting (PONV)
Therapeutic area: Gastrointestinal diseases - Digestive diseases
Country: Canada, France, Germany, USA
Trial details:
Latest
news: * On February 13, 2017, Acacia Pharma announced positive results from its fourth and final pivotal Phase 3 study investigating Baremsis™ (amisulpride injection, formerly APD421) for the rescue treatment of patients who develop post-operative nausea & vomiting (PONV), despite having received prior antiemetic prophylaxis. Acacia Pharma has now completed four pivotal Phase 3 studies of Baremsis™ successfully, all meeting their primary endpoint, and these will form the basis of the efficacy and safety package which the Company aims to submit to the FDA as part of its New Drug Application (NDA) in 1H 2017. The Company will seek a broad and unique approval for Baremsis™ for the rescue treatment and prophylaxis of PONV, alone and in combination. The Phase 3 rescue treatment trial compared two doses of Baremsis™ against placebo in patients with established nausea and/or vomiting after surgery, who had previously received prophylactic antiemetics. The double-blind study, the first ever major study to investigate rescue with a different class of antiemetic, took place in leading institutions in the USA, Canada, France and Germany and recruited 2,285 patients, of whom 705 (31%) went on to experience PONV and were randomised into the trial. The primary endpoint was the successful resolution of the episode of PONV (no recurrence of vomiting or requirement for further antiemetic rescue) in the 24-hour period after rescue treatment, termed a complete response. The optimum dose of Baremsis™ significantly improved the complete response rate when compared to placebo (p=0.003); the magnitude of effect was consistent with the Company's previous Phase 3 trial results. Detailed data will be presented in due course at relevant scientific meetings and submitted for publication in a peer-reviewed journal.
