DEA petitioned to de-schedule dual orexin receptor antagonist insomnia medications

Idorsia Pharmaceuticals announced that a citizen petition was filed on its behalf, asking the DEA to de-schedule the dual orexin receptor antagonist class of chronic insomnia medications.

According to a release from Idorsia, the request was based on review of data that demonstrate the dual orexin receptor antagonist (DORA) class of insomnia medications has a negligible abuse profile and potential for abuse, lacks nonmedical use and physical and psychological dependence, and should no longer be placed under the Controlled Substances Act. The DORA class is currently classified as Schedule IV.

A citizen petition can be filed to ask that a governing agency, such as the DEA or FDA, take or refrain from taking a particular action. Idorsia’s petition included three key points:

• Nearly a decade’s worth of post-marketing surveillance data suggest that the DORA class has insignificant potential for abuse and risk for abuse profile, lack of nonmedical use in the community and lack of physical or psychological dependence.
• Based on the federal surveillance systems, including FDA’s Adverse Events Reporting System, rates of abuse and dependence-related reports, serious adverse events and events requiring hospitalization associated with the DORA class are low incidence and substantially lower than other Schedule IV benzodiazepines and related drugs.
• Secondary analysis of the eight factors of the Controlled Substances Act, which is required during the scheduling process, supports removal of the DORA class from scheduling under the CSA.

“Idorsia is asking the DEA to de-schedule the DORA class as part of our continued commitment to treating insomnia,” Jean-Paul Clozel, MD, CEO of Idorsia, stated in the release. “Access to the DORA class of medicines for insomnia should not be limited by the constraints put in place to manage and restrict the use of scheduled drugs or controlled substances.”

Per the release, DORAs specifically target the orexin system by competitively binding and antagonizing both orexin receptors, thereby reversibly blocking the activity of orexin and reducing downstream activity of wake-promoting overactive neurotransmitters in insomnia. By targeting the fundamental mechanism of insomnia and not activating dopamine neurons, orexin receptor antagonism has a much lower risk for abuse, dependence and overdose reported with other Schedule IV drugs used to treat insomnia.

It is unclear whether the DEA will respond to, or take any related action on, the filed petition, the release stated.