U.K.-based specialty pharmaceutical firm Acacia Pharma reported positive data from a fourth pivotal study with its antiemetic drug Baremsis™ (amisulpride injection, or APD421). The firm said it anticipates filing an NDA with FDA during the first half of 2017.
Baremsis is a dopamine D2/D3 antagonist in development for rescue therapy of patients who develop post-operative nausea and vomiting (PONV) despite having previously received prophylactic antiemetics. “No other antiemetic 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,” commented Julian Gilbert, Ph.D., Acacia Pharma's CEO. The firm said it will look for broad approval of Baremsis for rescue treatment and prophylaxis of PONV, both as monotherapy and as combination therapy.
The reported Phase III placebo-controlled rescue therapy recruited 2285 patients in North America and Europe, 705 (31%) of whom went on to experience PONV and were randomized into the trial. The results showed that the optimum dose of Baremsis successfully resolved PONV in the 24-hour period after administration. All four Phase III Baremsis studies have met their primary endpoints.
Acacia is focused on developing treatments to support post-surgical or post-cancer therapy care. The firm’s clinical pipeline includes APD403, which contains the same active ingredient as Baremsis. APD403 is in Phase II development, both as an intravenous injection given before chemotherapy to help prevent acute chemotherapy-induced nausea and vomiting (CINV) and as a tablet to prevent delayed CINV. Acacia’s oromucosal liquid bethanechol formulation APD515 is also in Phase II development for the treatment of xerostomia (dry mouth). A fourth clinical candidiate, APD209, has successfully completed a Phase IIa study for managing cancer cachexia. ADP209 is an oral, fixed-dose combination of megestrol and formoterol.
