Cambridge (UK) and Indianapolis (US) – Acacia Pharma (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or chemotherapy, announces today that BARHEMSYS® (amisulpride injection) has been launched and is now commercially available in the US for order and delivery to customers through major wholesalers and specialty distributors. BARHEMSYS was approved by the US Food and Drug Administration (FDA) for the treatment and prevention of postoperative nausea & vomiting (PONV) on 26 February 2020.
“We are excited to announce today that BARHEMSYS is now available in the US for the millions of patients each year who suffer from PONV,” commented Mike Bolinder, Acacia Pharma’s CEO. “BARHEMSYS is the first and only antiemetic to be approved for the rescue treatment of PONV in patients who have failed prior prophylaxis with an agent of a different class using current standard of care and we estimate there are approximately 16 million such surgical patients each year in the US that go on to suffer from PONV despite receiving prophylaxis. We believe there will be strong demand for BARHEMSYS as US healthcare institutions seek to address surgical backlogs created by the coronavirus crisis and are very happy to make this new therapy available in the US.”
BARHEMSYS is now available for ordering in the US through the major wholesalers and selected specialty distributors, including Cardinal Health, Amerisource Bergen, Besse, McKesson, McKesson Medsurg, Morris and Dickson, and Curascript.
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 anesthetic gases and opioid painkillers and is particularly common following gynecological, abdominal, breast, eye, and ear operations, especially those lasting an hour or more. PONV has been ranked as the most undesirable of all surgical complications in some patient surveys, even worse than pain. Acacia Pharma estimates that approximately 65 million surgical procedures are conducted in the US each year that are eligible for antiemetic use to prevent PONV. Based on market research, Acacia Pharma estimates that the total market in the US for high-risk prophylactic and rescue treatment comprises an estimated 34 million patients annually.
BARHEMSYS is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist, which Acacia Pharma has developed and protected for the management of PONV. BARHEMSYS is indicated in adults for:
- treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis
- prevention of PONV, either alone or in combination with an antiemetic of a different class
Please click to access full Prescribing Information for BARHEMSYS. For more information, visit the company’s website www.BARHEMSYS.com
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 portfolio aims to address. Acacia Pharma’s first product, BARHEMSYS® (amisulpride injection) is available in the US for postoperative nausea & vomiting (PONV). BYFAVO™ (remimazolam) for injection, a very rapid onset/offset IV benzodiazepine sedative is approved in the US for use during invasive medical procedures in adults lasting 30 minutes or less, such as colonoscopy and bronchoscopy. BYFAVO is in-licensed from Paion UK Limited for the US market, and US launch is planned for 2H 2020. APD403 (intravenous and oral amisulpride), a selective dopamine antagonist for chemotherapy induced nausea & vomiting (CINV) has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.
Acacia Pharma is based in Cambridge, UK and its US operations are centred in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH. For more information, visit the company’s website at www.acaciapharma.com
About Gilde Healthcare
Gilde Healthcare is a specialized healthcare investor managing over €1.4 billion ($1.5 billion) across two fund strategies: venture & growth capital and private equity. Gilde Healthcare’s venture & growth capital fund invests in fast growing companies active in digital health, medtech and therapeutics. The venture & growth companies are based in Europe and North America. Gilde Healthcare’s private equity fund invests in profitable European lower mid-market healthcare companies with a focus on the Benelux and DACH region. The private equity fund targets healthcare providers, suppliers of medical products and service providers in the healthcare market. For more information, visit the company’s website at www.gildehealthcare.com.