Acacia Pharma Announces US FDA Approval of BARHEMSYS (amisulpride) for the Treatment and Prevention of Postoperative Nausea and Vomiting (PONV) - Seite 3

The most common side effects observed across the four pivotal studies, reported in at least 2% of adult patients who received BARHEMSYS and at a higher rate than placebo were: infusion site pain (6% vs 4% with placebo), chills (4% vs 3%), hypokalemia (4% vs 2%), procedural hypotension (3% vs 2%), and abdominal distension (2% vs 1%). Serum prolactin concentrations were measured in one prophylaxis study where 5% (9/176) of BARHEMSYS-treated patients had increased blood prolactin reported as an adverse reaction compared to 1% (1/166) of placebo-treated patients.

Acacia Pharma’s second product, Byfavo (remimazolam injection), was recently in-licensed from Cosmo Pharmaceuticals NV and an NDA is currently under review by FDA for use in procedural sedation in adults. The application has a target PDUFA action date of 5 April 2020. Subject to approval, the Company also intends to launch Byfavo in the US during 2020 and to commercialize Byfavo using the same sales and marketing infrastructure.

Conference Call Information

The Acacia Pharma management team will host a conference call today, Thursday 27 February 2020, at 10:00 am CET (09:00 am GMT). 

Please join the event conference 5-10 minutes prior to the start using the password Acacia Pharma and any of the phone numbers provided below.

Password: Acacia Pharma

Belgium                       0800 746 68
The Netherlands         0800 022 9132
United Kingdom          0808 109 0700
United States              1 866 966 5335
International                [phone]

The conference call presentation can be accessed prior to the call by visiting the investors section of the Company’s website (Financial Reports and Presentations) at www.acaciapharma.com. A recording of the conference call will be available in the same place for 30 days following the call.

Contacts

Acacia Pharma Group plc
Mike Bolinder, CEO
Christine Soden, CFO
[phone]
[e-mail]

Citigate Dewe Rogerson (Financial PR)
Mark Swallow, Frazer Hall, David Dible
[phone]
[e-mail]

About Acacia Pharma

Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer chemotherapy. The Company has identified important and commercially attractive unmet needs in these areas that its product pipeline aims to address.