Rescue Tx for Post-Op Nausea/Vomiting Effective in Pivotal Trial
Acacia has announced positive results from its final pivotal Phase 3 study investigating BAREMSIS (amisulpride injection, formerly APD421) for the rescue treatment of patients who develop post-operative nausea and vomiting (PONV), despite having received prior antiemetic prophylaxis.
BAREMSIS, a novel dopamine D2/D3 antagonist antiemetic, was tested against placebo in patients with established nausea and/or vomiting after surgery, who had received prophylactic antiemetics. A total of 705 patients who experienced PONV were randomized to receive placebo or BAREMSIS.
The primary endpoint of complete response rate – successful resolution of the PONV episode – in the 24-hours after rescue treatment was shown to be significantly greater with BAREMSIS treatment when compared to placebo (P=0.003). These findings are in line with the results from the previous four Phase 3 trials of BAREMSIS.
“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,” said Dr. Julian Gilbert, CEO of Acacia. The company will seek a broad and unique approval for BAREMSIS for the rescue treatment and prophylaxis of PONV. They aim to submit their New Drug Application (NDA) to the Food and Drug Administration in 1H 2017.
For more information visit Acaciapharma.com.