13 February 2017
Positive Results From 4th and Final Pivotal Phase 3 Trial of BAREMSIS™ for Rescue Treatment of PONV
Extensive Phase 3 programme demonstrates clinical potential of BAREMSIS in rescue treatment and prophylaxis of PONV – NDA to be submitted to the US FDA 1H 2017
Cambridge, UK – 13th February 2017: Acacia Pharma Group Ltd (“Acacia Pharma”), the supportive care company developing products for US and international markets, announces 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.
Dr Julian Gilbert, Acacia Pharma’s CEO commented: “We are delighted with these results demonstrating that BAREMSIS is safe and effective at rescuing patients who suffer PONV despite having received prior prophylaxis with standard anti-emetics. No other anti-emetic has a specific label for treating this significant unmet need and we intend to position BAREMSIS as the drug of choice for treating the 30-40% of surgical patients who suffer PONV despite prior prophylaxis, as well as for combination prophylaxis in high-risk patients.”
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 US 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.
PONV is distressing, can have a detrimental impact on surgical outcomes and significantly impede the post-operative recovery process. It can delay hospital discharge, lead to unanticipated readmissions increasing healthcare costs and give the patient a poor surgical experience. Better management of PONV can therefore decrease hospital costs and improve patient outcomes and satisfaction scores.
Surgical patients at moderate or high risk of PONV are given prophylactic antiemetics prior to surgery, with standard-of-care based upon 5HT3 antagonists and corticosteroids. However, up to 40% of these patients develop PONV and must be treated with an antiemetic from a different mechanistic class. BAREMSIS is a dopamine antagonist antiemetic and offers anaesthetists a drug that is able to fulfil this important unmet medical need and better manage PONV.
The Phase 3 rescue treatment trial compared two doses of BAREMSIS, a novel dopamine D2/D3 antagonist antiemetic, 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.