Acacia Pharma launches BYFAVO™ in the United States for procedural sedation in adults undergoing medical procedures lasting 30 minutes or less

  • Approximately 40 million procedures take place annually in the US that require the use of procedural sedation
  • BYFAVO is the second Acacia Pharma product approved and launched in the US in the last year and extends its portfolio of new products targeting unmet needs in anesthesia

Cambridge (UK), Indianapolis (US) and Utrecht (the Netherlands) - Acacia Pharma (EURONEXT: ACPH), 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, announces today that BYFAVO™ (remimazolam) has been launched and is now commercially available in the US for order and delivery to customers through major wholesalers and specialty distributors.

BYFAVO was approved by the US Food and Drug Administration (FDA) on 2 July 2020 for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. It received its Schedule IV designation from the US Drug Enforcement Administration (DEA) on 6 October 2020, finalizing the approval process and clearing the way for final packaging and shipping to the US.

Acacia Pharma has built critical sales, marketing, medical education and operational support teams over the past two years to allow it to directly commercialize both BYFAVO and BARHEMSYS® in the US through its own sales channels. The company’s experienced commercial team is focused on addressing the combined large market opportunities for procedural sedation and prevention and treatment of post-operative nausea & vomiting (PONV), which BYFAVO and BARHEMSYS target, respectively, that exist in the US hospital market. The initial focus of the commercial team over the first year of launch is to ensure that BYFAVO is listed on hospital formularies, based on the unmet needs it can address and the health economic benefits it can deliver.

BYFAVO 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.

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 marketed in the US for the management of postoperative nausea & vomiting (PONV).

BYFAVO™ (remimazolam) for injection, a very rapid onset/offset IV benzodiazepine sedative is approved and launched 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.
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 has its US headquarters in Indianapolis, IN and its R&D operations are centered in Cambridge, UK. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH.

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