BARHEMSYS™ (formerly APD421) is an intravenous formulation of amisulpride, a selective dopamine antagonist, which has completed Phase 3 clinical development for the prophylaxis and treatment of PONV, alone and in combination with other antiemetics. A New Drug Application (NDA) seeking marketing approval for BARHEMSYS™ in these indications has been accepted for review by the FDA. Under the Prescription Drug User Fee Act (PDUFA), FDA has set a target date of 5 October 2018 to complete its review.
Four pivotal Phase 3 clinical trials investigating BARHEMSYS™ for the management of PONV have been successfully completed. Two investigated the treatment of established PONV (one in patients who had received prior prophylaxis with standard antiemetics, and one in patients who had not received any prophylaxis) and two investigated the prophylaxis (prevention) of PONV alone, or in combination with standard antiemetics.
PONV is a common complication of surgery, occurring in approximately 30% of surgical patients and up to 80% of high-risk patients. It is associated with the use of anaesthetic gases and opioid pain-killers and is particularly common following gynaecological, abdominal, breast, eye and ear operations, especially those lasting an hour or more.
The Group estimates that approximately 65 million surgical procedures are conducted in the US each year that require injectable analgesia and are eligible for antiemetic use to prevent PONV. Based on market research, Acacia Pharma estimates that the total market in the US for prophylactic and rescue treatment comprises an estimated 34 million treatment events annually.
PONV has been ranked as the most undesirable of all surgical complications by patients and contributes significantly to patient anxiety and distress. PONV can delay hospital discharge; result in re-admission after in-patient procedures; and lead to day-case patients being admitted to hospital, all of which can result in significantly increased healthcare costs.
In addition, The Patient Protection and Affordable Care Act of 2010 (“Affordable Care Act”) in the US has linked quality of care and patient satisfaction to reimbursement. Appropriate management of PONV is key to improving patient satisfaction scores, and therefore BARHEMSYS™ could provide opportunities for reimbursement as well as for reducing healthcare costs.