Acacia Pharma nearer to Byfavo launch as it gets DEA scheduling

Shares of Acacia Pharma (Euronext: ACPH) closed up 4.5% at 2.22 euros today, as the UK company revealed 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). Analysts have forecast peak sales of around $125 million for Byfavo, but that was before the favorable DEA scheduling was announced.

Byfavo, in-licensed for the US market from Italy’s Cosmo Pharmaceuticals, received approval from the US Food and Drug Administration on July 2, 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 USA, with launch expected by the end of 2020.