Acacia Pharma Group Ltd, a pharmaceutical company developing
and commercialising hospital products for US and international
markets, announces that the New Drug Application (NDA)
for Baremsis (amisulpride injection, formerly APD421) for the
management of post-operative nausea & vomiting (PONV), has
been accepted for filing by the US Food and Drug Administration
(FDA). Under the Prescription Drug User Fee Act (PDUFA), the FDA
has set a target date of 5th October 2018 to complete its review.
The NDA submission includes data from four positive phase 3
studies, including the first ever randomised, controlled trial to show
successful treatment of active PONV in patients who have failed prior
prophylaxis. More than 3,300 surgical patients and healthy volunteers
were enrolled in the Baremsis clinical development programme.
Dr Julian Gilbert, Acacia Pharma's chief executive officer
commented: "We are delighted to have achieved this major
milestone for the Company. Our goal is for Baremsis to be the first
drug specifically approved for the treatment of PONV in patients
who have failed prophylaxis, an area of high unmet need, and to
become established as the new standard of care. The broad and
unique label we have targeted also includes prophylaxis of PONV,
alone and in combination with other anti-emetics. We are now
moving forward with our US commercialisation plans to deliver an
effective management option for the millions of patients each year
suffering from, or at risk of, PONV."
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