Acacia Pharma announces BYFAVO™ (remimazolam), its Newly Approved Product for Procedural Sedation, Clears Final Hurdle on Path to Commercial Launch in the US

Acacia Pharma Group plc (“Acacia Pharma” or the “Company”), 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.

Mike Bolinder, Acacia Pharma’s CEO commented “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, 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.”

About BYFAVO™

BYFAVO (remimazolam) for injection is a very rapid onset/offset intravenous benzodiazepine sedative for use during invasive medical procedures in adult patients lasting 30 minutes or less, such as during colonoscopy and bronchoscopy. Approximately 25 million such procedures take place annually in the US, of which around 90% use moderate sedation. 

Cosmo in-licensed the US rights to BYFAVO from Paion AG in 2016 and together they have progressed the product candidate through to registration. BYFAVO is now approved in the US and is indicated for the induction and maintenance of procedural sedation in adults lasting 30 minutes or less.

Important Safety Information for BYFAVO™ (remimazolam) Injection

Indications

BYFAVO is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.

Important Safety Information

WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS

Personnel and Equipment for Monitoring and Resuscitation

  • Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO. 
  • Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. 
  • BYFAVO has been associated with hypoxia, bradycardia, and hypotension. Continuously monitor vital signs during sedation and during the recovery period.
  • Resuscitative drugs, and age- and size-appropriate equipment for bag-valve-mask–assisted ventilation must be immediately available during administration of BYFAVO.

Risks From Concomitant Use With Opioid Analgesics and Other Sedative-Hypnotics

Concomitant use of benzodiazepines, including BYFAVO, and opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative effect of intravenous BYFAVO can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation.

Contraindication                                                                 

BYFAVO is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40.

Personnel and Equipment for Monitoring and Resuscitation

Clinically notable hypoxia, bradycardia, and hypotension were observed in Phase 3 studies of BYFAVO. Continuously monitor vital signs during sedation and through the recovery period. Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO. Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. Resuscitative drugs, and age- and size-appropriate equipment for bag-valve-mask–assisted ventilation must be immediately available during administration of BYFAVO. Consider the potential for worsened cardiorespiratory depression prior to using BYFAVO concomitantly with other drugs that have the same potential (e.g., opioid analgesics or other sedative-hypnotics). Administer supplemental oxygen to sedated patients through the recovery period. A benzodiazepine reversal agent (flumazenil) should be immediately available during administration of BYFAVO.

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