Idorsia Files Petition with the Drug Enforcement Administration (DEA) Urging Them to De-Schedule Dual Orexin Receptor Antagonist Class of Insomnia Medications
RADNOR, Pa., April 4, 2023 /PRNewswire/ -- Yesterday, a Citizen Petition (CP) was filed on behalf of Idorsia Pharmaceuticals (SIX: IDIA), urging the 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.1
Chronic insomnia is a sleep disorder when a person has trouble falling or staying asleep. Insomnia impacts approximately 25 million American adults.2 Among the most commonly prescribed medicines that are approved to treat insomnia are benzodiazepines and Z-drugs (including zopiclone, eszopiclone, zaleplon and zolpidem).3 These drugs are only recommended for short-term use with frequent re-evaluation and due to the risk of dependance and misuse and abuse, are scheduled as Schedule IV under the Controlled Substances Act.4 The Schedule IV classification of the DORA class puts them in the same classification as benzodiazepines and Z-drugs; however, the DORA class works differently, blocking signals in the brain that stimulate wakefulness addressing chronic insomnia without creating dependence and with a negligible potential of abuse. 1
"Given the rising cases of substance abuse disorder with certain prescription medications in the United States, I'm pleased to see data from the DORA class, which shows the negligible abuse potential of DORAs when treating insomnia," said Vaughn McCall, MD, Professor and Case Distinguished Chair of the Department of Psychiatry and Health Behavior at Augusta University. "I am hopeful that the DEA will consider de-scheduling the DORA class as it is critical in preventing the overuse of other medications, which may be abused or misused, to treat insomnia."
The CP requests that the DEA Administrator initiate a rulemaking proceeding to remove the DORA class medications from scheduling under the Controlled Substances Act (CSA) based on the following three points:
"Idorsia is asking the DEA to de-schedule the DORA class as part of our continued commitment to treating insomnia." said Jean-Paul Clozel, MD, Chief Executive Officer of Idorsia. "As there is significantly more data and evidence on the DORA class today than when these drugs were first approved in 2014, we believe that the DEA should reconsider its decision to schedule these drugs, considering they have negligible abuse profiles and potential for abuse. 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."
DORAs block the activity of orexin, they "turn down" overactive wakefulness pathways, in contrast to insomnia treatments which act via general CNS sedation. DORAs specifically target the orexin system by competitively binding and antagonizing both orexin receptors, thereby reversibly blocking the activity of orexin. Blocking orexin receptors reduces the downstream activity of the wake-promoting neurotransmitters that are overactive in insomnia. As a result, orexin receptor antagonism targets the fundamental mechanism of insomnia and does not activate dopamine neurons, thus representing much lower risks of abuse, dependence, and overdose than conventional Schedule IV drugs used to treat insomnia.
A Citizen Petition can be filed to ask that a governing agency, like the DEA or US Food and Drug Administration, take or refrain from taking a particular action. Any person may file a Citizen Petition, and any person may comment on a petition that has been filed. Idorsia cannot predict when or if the DEA will respond to or otherwise take any action concerning the Citizen Petition filed.
To view the petition, click here.
Notes to the editor
Insomnia is a condition of overactive brain activity during sleep, and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia.
Insomnia is the most common sleep disorder, affecting more than 25 million adults in the US.2 Poor quality or insufficient sleep can affect many aspects of the daily lives of people with trouble sleeping including the ability to concentrate, mood and energy levels.4 In the long-term, insomnia is associated with numerous serious health conditions, such as psychiatric disorders, cardiovascular disease, type 2 diabetes, substance abuse and dementia.7,8,9
About Idorsia US
Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1'000 highly qualified specialists dedicated to realizing our ambitious targets.
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SOURCE Idorsia Pharmaceuticals U.S.
Company Codes: Swiss:IDIA