DGAP-News PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS
DGAP-News: PAION AG / Key word(s): Product Launch
PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS
- Approximately 40 million procedures take place annually in the U.S. that require the use of procedural sedation
- BYFAVO(TM) is the second Acacia Pharma product approved and launched in the U.S. in the last year and extends its portfolio of new products targeting unmet needs in anesthesia
Aachen (Germany), 28 January 2021 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that its U.S. BYFAVO(TM) (remimazolam) licensee Acacia Pharma (Acacia) has informed PAION today that BYFAVO(TM) has been launched and is now commercially available in the U.S. for order and delivery to customers through major wholesalers and specialty distributors.
BYFAVO(TM) was approved by the U.S. 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 U.S. Drug Enforcement Administration (DEA) on 6 October 2020, finalizing the approval process and clearing the way for final packaging and shipping to the U.S.
Acacia has built critical sales, marketing, medical education and operational support teams over the past two years to allow it to directly commercialize both BYFAVO(TM) and BARHEMSYS(R) in the U.S. through its own sales channels. Acacia'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(TM) and BARHEMSYS(R) target, respectively, that exist in the U.S. hospital market. The initial focus of the commercial team over the first year of launch is to ensure that BYFAVO(TM) is listed on hospital formularies, based on the unmet needs it can address and the health economic benefits it can deliver.