DEA Proposed Schedule IV Classification For Suvorexant Good News For Merck
The U.S. Drug Enforcement Administration (DEA) proposed last week that Merck’s insomnia drug Suvorexant be classified as a Schedule IV drug under the Controlled Substances Act (CSA) based on the FDA’s recommendation. The DEA decision might speed Suvorexant’s entry into the market should the FDA grant approval for the drug.
Suvorexant is an investigational orexin receptor antagonist intended for the treatment of patients with insomnia. The drug works by reducing wakefulness-promoting effects of orexins, thereby facilitating the sleep process in patients. Merck has already completed several Phase III trials for Suvorexant, but has yet to win approval from the FDA.
The FDA issued a Complete Response Letter in late 2013 after members of its Peripheral and Central Nervous System Drugs Advisory Committee and Merck disagreed about the proper dosage for Suvorexant. The company had sought a 15mg/20mg dosage for elderly and non-elderly patients respectively, but the committee pushed for a lower 10 mg dose. The ensuing disagreement resulted in the denial of approval by the FDA.
The DEA, however, made an early proposal to classify Suvorexant under the CSA. The DEA notice declared, “On June 27, 2013, the HHS provided the DEA with a scientific and medical evaluation document prepared by the FDA entitled “Basis for the Recommendation to Place Suvorexant in Schedule IV of the Controlled Substances Act. …In response, the DEA reviewed the scientific and medical evaluation and scheduling recommendation provided by the HHS, and all other relevant data, and completed its own eight-factor review document pursuant to 21 U.S.C. 811(c). …Based on these findings, the Deputy Administrator of the DEA concludes that suvorexant ([(7 R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl][5-methyl-2-(2 H-1,2,3-triazol-2-yl)phenyl]methanone), including its salts, isomers, and salts of isomers warrants control in schedule IV of the CSA. 21 U.S.C. 812(b)(4).”
Without the DEA approval, Suvorexant will not be allowed on the market even if the FDA gives its thumbs up. Some drugs such as Belviq, another Schedule IV drug, spent a year waiting for DEA scheduling even after it received FDA approval. Regulatory Focus says the DEA proposal signals a faster entry for Suvorexant should the FDA approves Merck’s application.
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