21 March 2016
Initiation Of Second Pivotal Phase 3 Treatment Trial With BAREMSIS® In PONV
NDA filing expected in second half of 2016
Cambridge, UK – 21st March 2016: Acacia Pharma Group plc (“Acacia Pharma”), the supportive care company developing products for US and international markets, announces the initiation of its second pivotal Phase 3 treatment study, investigating BAREMSIS® (amisulpride injection, formerly APD421) in surgical patients who develop post-operative nausea & vomiting (PONV), despite having received antiemetic prophylaxis before surgery.
International consensus guidelines recommend that surgical patients who develop PONV should be treated with an antiemetic with a different mechanism of action from any antiemetic given before surgery for the prevention of PONV. Currently two classes of antiemetics are predominantly given prophylactically in an attempt to prevent PONV. These are 5HT3 antagonists (usually ondansetron) and corticosteroids (usually dexamethasone). A safe and effective third antiemetic mechanism is therefore required to treat subsequent PONV and BAREMSIS, a dopamine antagonist antiemetic, could fulfil this need.
This second Phase 3 treatment trial compares two doses of BAREMSIS against placebo in post-surgical patients who develop PONV despite prior antiemetic prophylaxis. The study is taking place in leading institutions in the USA, Canada, France and Germany and aims to recruit around 560 patients. The primary endpoint is the successful resolution of the episode of PONV, with no recurrence of vomiting or requirement for further antiemetic rescue in the 24-hour period after treatment.
Dr Julian Gilbert, CEO said: “Up to 40% of surgical patients who receive a preventative antiemetic prior to surgery, still develop PONV which extends hospital stays, can lead to readmissions and subsequently increases healthcare costs. Unfortunately, the PONV treatment options currently available to anaesthetists for these patients are limited due to the extensive prophylactic use of 5HT3 antagonists and corticosteroids. We believe that BAREMSIS, a dopamine antagonist antiemetic that we have already shown to be safe and effective in preventing PONV, could provide the solution to this problem and this study is designed to investigate its use in treatment.”
A Phase 3 treatment study of BAREMSIS in around 560 surgical patients who develop PONV and who have not received prior prophylaxis is ongoing, and Acacia Pharma has already successfully completed two Phase 3 prophylaxis studies showing that BAREMSIS is safe and effective at preventing PONV, when given either alone or in combination with other antiemetics, prior to surgery. These three studies, along with the study we have announced the initiation of today, will complete the efficacy package Acacia Pharma aims to submit to the US FDA as part of its BAREMSIS New Drug Application (NDA) in the second half of 2016, looking to gain approval for the treatment and prophylaxis of PONV alone and in combination, a novel and unique label if approved.