Acacia Pharma Announces Supportive Cardiac Safety Data For BARHEMSYS™
Cambridge, UK and Indianapolis, US – 22 January 2019: Acacia Pharma Group plc (“Acacia Pharma”, the “Company”) (EURONEXT: ACPH) announces results from its latest study of BARHEMSYS™ (intravenous amisulpride), its anti-emetic currently under FDA review for the management of post-operative nausea & vomiting (PONV).
The study did not find a significant risk for heart rhythm disturbances (arrhythmias) at the highest proposed dose of BARHEMSYS, given alone or in combination with intravenous ondansetron, a widely used PONV therapy with a known effect on the heart trace.
Commenting on the results, Dr Gabriel Fox, Acacia Pharma’s Chief Medical Officer, said: “These latest data give us increased confidence that a single 10 mg dose of BARHEMSYS, which has previously been shown to reduce PONV in clinical trials, will not have a clinically significant effect on the QTc interval, part of the ECG trace which is an important indicator of cardiac risk, even when given with ondansetron. If approved, BARHEMSYS is likely to be given to many patients also receiving ondansetron and it is therefore encouraging that no cardiac or other safety signals were identified with the combination.”Back to News