DEA places new narcolepsy drug Orzeyful in Schedule IV, saying its abuse potential resembles phentermine's
The interim rule took effect on November 12, putting Takeda's oveporexton in the same federal drug schedule as phentermine. Comments are due December 14.
What it means for you
- An interim final rule effective November 12 places oveporexton, sold as Orzeyful, in Schedule IV of the Controlled Substances Act.
- FDA approved Orzeyful on August 5, 2026, to treat narcolepsy type 1 in adults. DEA says no other drug that works the same way is listed under the law.
- HHS and DEA concluded that its abuse potential is similar to that of phentermine, based on animal studies and a study in recreational drug users given doses above the prescribed range.
- Patients who have a lawful prescription do not need to register with DEA, but prescriptions must follow the federal rules for controlled substances.
- Comments and hearing requests are due by December 14, 2026. DEA must then issue a final rule.