Idorsia seeks DEA review of insomnia drug scheduling

A Citizen Petition (CP) has been filed on behalf of Swiss biotech Idorsia Pharmaceuticals (SIX: IDIA), urging the USA’s Drug Enforcement Administration (DEA) to de-schedule the dual orexin receptor antagonist (DORA) class of chronic insomnia medications based on a review of evidence from available data, including post-marketing surveillance data.

The CP to de-schedule the DORA class outlines scientific and medical evidence demonstrating that the DORA class has a negligible abuse profile and potential for abuse, lacks non-medical use in the community, lacks physical and psychological dependence, and therefore, should not be a scheduled class under the Controlled Substances Act.

Idorsia's Quviviq (daridorexant), a DORA sleeping pill for those with insomnia, was approved by the Food and Drug Administration (FDA) in January last year, but the company had to wait until May that year before it received DEA scheduling.