•BYFAVO expected to be commercially available in the US before the end of the year
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
Cambridge, UK and Indianapolis, US – 6 October 2020: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (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, today announced that the US Drug Enforcement Administration (DEA) has designated its procedural sedative BYFAVO™ (remimazolam injection) as a Schedule IV medicine. This designation is the schedule for drugs with a low potential for abuse and low risk of dependence and is consistent with that granted to many other benzodiazepine drugs, including midazolam and diazepam (Valium®).
BYFAVO received approval from 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. Scheduling by DEA represents the final requirement for BYFAVO to be marketed in the US, with launch expected by the end of 2020.
“We are grateful to DEA for its timely determination of the scheduling of BYFAVO and are excited to bring this novel product to the US market,” commented Mike Bolinder, Acacia Pharma’s CEO. “We will start the process of labeling and packaging our stock of commercial product immediately so that we can make BYFAVO available to patients as soon as possible. We anticipate the product being available for sale in the US prior to the end of the year. Our first product, BARHEMSYS® (amisulpride injection) for postoperative nausea & vomiting, was launched in August and we are already registering product sales. We are delighted to be able to provide these two medicines to physicians and their patients in the United States.”