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Acacia Pharma Group plc have announced 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, pictured, said: “These latest data give us increased confidence that a single 10mg 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.”
In 30 healthy volunteers, the average maximum effect on the QTc interval of a single 10 mg dose of BARHEMSYS, infused over one minute, was 5.2 milliseconds (90 per cent confidence interval 3.53-6.96 milliseconds). When a standard 4 mg dose of IV ondansetron was given at the same time, the average maximum effect was 7.3 milliseconds (90 per cent confidence interval 5.48-9.16 milliseconds). The internationally agreed threshold level of regulatory concern for serious arrhythmias, such as torsade de pointes, is a mean effect on QTc of 10 milliseconds.
The randomised, double-blind, placebo-controlled, cross-over study, conducted in a specialist Phase 1 trials unit in London, UK, also demonstrated that a second 10 mg dose of BARHEMSYS, given two hours after the first, had a similar pharmacokinetic profile and did not significantly affect the QT or clinical safety profile of the drug. No serious adverse events were reported in the trial and there was no material difference in safety profile between BARHEMSYS (with or without concomitant ondansetron) and placebo.
The most common adverse events were infusion site pain/discomfort, which occurred in eight subjects (28 per cent) with BARHEMSYS alone, nine subjects (30 per cent) with BARHEMSYS plus ondansetron and 12 subjects (40 per cent) with placebo; and headache, which occurred in four subjects (14 per cent) with BARHEMSYS alone, three subjects (10 per cent) with BARHEMSYS plus ondansetron and two subjects (7 per cent) with placebo.
BARHEMSYS is currently under review by FDA for the proposed indications of the treatment of established PONV, whether or not prior prophylaxis was given, and the prevention of PONV, alone or in combination with other antiemetics, with a target action date of May 5, 2019.
For more information, visit: www.acaciapharma.com
