In the U.S., the FDA (U.S. Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.
In January 2020, Cosmo Pharmaceuticals (Cosmo) sublicensed BYFAVOTM U.S. rights to Acacia Pharma (Acacia). In July 2020, after market approval of BYFAVOTM, PAION, Cosmo and Acacia agreed to assign the BYFAVOTM license agreement signed in 2016 between Cosmo and PAION to Acacia. The terms of the license agreement remain unchanged but will now be between PAION and Acacia, with Cosmo no longer being a party to the agreement.
Acacia plans to launch BYFAVOTM in the U.S. in the second half of 2020. As a prerequisite, BYFAVOTM will need to be classified by the Drug Enforcement Administration (DEA) under the so-called Controlled Substances Act. The drug classification schedule classifies drugs into groups based on risk of abuse. Midazolam, for example, is included in Schedule IV. Substances in this schedule have a lower potential for abuse relative to substances in Schedule III. PAION expects that remimazolam will receive the same classification as midazolam.