Date: 2015-05-06
Type of information: Results
phase: 2
Announcement: results
Company: Acacia Pharma (UK)
Product: APD403 (amisulpride)
Action
mechanism: dopamine D2 antagonist. APD403 contains the currently marketed dopamine D2 /D3 antagonist amisulpride for the new, patent-protected, use of management of CINV. The active ingredient is also being developed as APD421 for the prevention of post-operative nausea & vomiting (PONV), with two pivotal Phase III clinical studies having been initiated recently. APD403 is a novel and proprietary product containing the dopamine antagonist amisulpride, which Acacia Pharma is also developing as APD421 for the prevention and treatment of post-operative nausea & vomiting (PONV).
Disease: chemotherapy-induced nausea & vomiting (CINV)
Therapeutic area: Cancer - Oncology
Country: Denmark, Germany, UK, USA
Trial
details: The Phase II study is taking place in around 25 major centres in the UK, Denmark, Germany and the USA and aims to recruit 315 cancer patients receiving highly emetogenic chemotherapy (HEC). The trial compares 3 doses of APD403 against placebo in the delayed phase of CINV. The primary endpoint is no vomiting or retching and no requirement for anti-emetic rescue medication for 5 days after the start of chemotherapy administration. The incidence and severity of nausea is being studied as a secondary endpoint.
Latest
news: * On May 6, 2015, Acacia Pharma, a specialty pharmaceutical company developing supportive care products for post-surgical and cancer patients in the US and international markets, announced positive results from its Phase 2 study of APD403 in the prevention of chemotherapy-induced nausea & vomiting (CINV).The randomised, double blind, Phase 2 study was conducted in 342 cancer patients receiving HEC (either high-dose cisplatin, or cyclophosphamide and an anthracycline for breast cancer). The trial compared 3 doses of APD403 against placebo in the delayed phase of CINV. All patients received the same acute-phase anti-emetic prophylaxis. The primary endpoint was complete response (no vomiting or retching and no requirement for anti-emetic rescue medication) in the period 24-120 hours after the administration of chemotherapy. APD403 was significantly superior to placebo at preventing delayed CINV, with the optimal dose improving the complete response rate by 26% (p=0.002) and significantly (p<0.05) reducing the incidence of both nausea and vomiting, compared to placebo. Complete response in the overall phase (0-120 hours) was also significantly improved (p=0.015). The safety profile was excellent, with fewer adverse events reported in each of the APD403 arms than in the placebo arm. Detailed data from this study will be presented at an upcoming scientific meeting and submitted for publication in a peer-reviewed journal.
