The Drug Enforcement Administration has placed Sage Therapeutics’ recently-approved postpartum depression drug Zulresso (brexanolone) in Schedule IV of its controlled substances list.
The FDA approved Zulresso in late March as the first ever drug specifically for treatment of PPD. The treatment requires an IV infusion for 60 hours.
The agency flagged the drug’s similarities to Schedule IV sedatives like midazolam and alprazolam that make it a potential target for diversion, urging the DEA to list it in Schedule IV. HHS also cited the lack of information currently available about the injectable drug’s abusability and the fact that it is a new molecular entity.
After reviewing HHS’ scientific and medical evaluation, the DEA conducted an appraisal of its own and reached the same conclusions. When the drug becomes available, it’s “likely to pose a public health risk to a degree similar to schedule IV benzodiazepines,” the DEA said.