DEA Proposes Reclassifying QUVIVIQ and Other Dual Orexin Receptor Antagonists from Schedule IV to Schedule V in the US – Idorsia

Idorsia Ltd announces that the US Drug Enforcement Administration (DEA) will publish a proposed rule to reclassify dual orexin receptor antagonists (DORAs) from Schedule IV to Schedule V under the Controlled Substances Act (CSA).

 

 

The proposal will be open to public comment for a duration of 30 days from publication.

The DEA’s proposed rule follows a scientific and medical evaluation and scheduling recommendation from HHS, considering the statutory eight factors, which the DEA then reviewed in its own eight-factor analysis.

“We view the recommendation to reclassify to the least restrictive schedule V as an important first step. The proposed reclassification recognizes the favorable profile of daridorexant compared with traditional sedative-hypnotics. While we believe that the available evidence supports full descheduling, we will now analyze the proposal in detail and provide comments through the appropriate forum. We hope the continued removal of restrictions paves the way for more patients to benefit from the DORA class.” – Jean-Paul Clozel, MD, Chairman and interim CEO of Idorsia.

Next steps

The DEA will accept public comments on the proposed rule before issuing a final decision.