Classified as a Schedule IV controlled substance, Idorisia’s potentially game-changing insomnia treatment Quviviq is under tight control by the Drug Enforcement Agency (DEA), just like virtually every other medication for the condition.
But Idorsia—a Swiss spinout of Johnson & Johnson subsidiary Actelion—is anxious to get rid of its “controlled substance” label, filing (PDF) a Citizen Petition (CP) with the agency this week.
Idorsia is not only angling to clear Quviviq from the Schedule IV list, the petition requests de-scheduling for all drugs in its dual orexin receptor (DORA) class.
Quviviq, which was approved in January of last year. is the third DORA on the market for insomnia—after Merck’s Belsomra and Eisai’s Dayvigo—but is considered the only one with blockbuster potential because of its unique ability to both induce sleep and keep patients alert during the day.
In its petition, Idorsia cites eight years of post-marketing surveillance data which provides evidence that the DORA class has negligible potential to be abused. Idorsia points to the lack physical and psychological dependence from DORA drugs and no evidence of non-medical use of them.
“We are a completely different drug, without this risk,” Idorsia CEO Jean-Paul Clozel said in an interview. “This scheduling should be taken away.”
Many medicines commonly prescribed for insomnia are benzodiazepines and Z-drugs—including zopiclone, eszopiclone, zaleplon and zolpidem. These are only recommended for short-term use with frequent re-evaluation and due to the risk of dependance and misuse and abuse, are classified as Schedule IV under the Controlled Substances Act.
But DORA class drugs work differently, blocking signals in the brain that stimulate wakefulness, addressing insomnia without creating dependence, Idorsia says.
Clozel said that when his company pursued approval in the United States, there was little it could do to challenge that it would be considered a controlled substance.
"We discussed it with the FDA and they said, since the two previous of the class had been classified like that, therefore we are going to do it," Clozel said. "Without giving any scientific reason, there was no real discussion."
Getting DORA drugs off schedule would bring much more clarity to prescribers and patients, separating them from those drugs that are classified as controlled substances, Idorsia says.
“One consequence of this scheduling is that today the biggest prescribed drug for sleep in the U.S. is Tazodone, which is not indicated for sleep,” Clozel said. “People use a side effect of this anti-depressant simply because it is not scheduled.”
Quviviq was in development for 25 years under the husband-wife team of Clozel and his wife Martine, who is Idorsia’s Chief Scientific Officer. After launching in May of last year, Quviviq generated $6.5 million in sales.
Besomra, which was approved in 2014, had sales of $258 million last year, a 27% fall from the previous 2021. Dayvigo, which was approved in 2019, had sales of $67 million in 2021.