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Regulatory News | 27 August 2014 | By Alexander Gaffney, RAC
The US Drug Enforcement Administration (DEA) has given a final and long-awaited approval to Merck to market its new insomnia drug Belsomra (suvorexant) as a Schedule IV drug.
Belsomra is an orexin receptor antagonist intended to treat insomnia in patients. While its sponsor, Merck, has already obtained FDA approval to market the drug, it has been awaiting scheduling by DEA as a controlled substance under the Controlled Substances Act (CSA).
In February 2014, DEA released a rule which proposed classifying suvorexant as a Schedule IV drug based on an eight-factor analysis conducted by FDA. That analysis had determined that the drug, which works by reducing wakefulness, could be abused in a manner similar to other sedatives such as Ambien (zolpidem), which is also a Schedule IV drug.
Under the CSA's rating system, Schedule IV drugs are those with a low but present potential for abuse, a clear medical use and minimal health effects associated with abuse of the drug. The classification means that refills on the drug will be limited so as to limit abuse, and the drug will be subject to tighter labeling, registration, packaging and other requirements.
As Focus explained at the time, the timing of DEA's scheduling decision could actually be construed as positive for Merck. Other companies, such as Arena Pharmaceuticals, have described the DEA scheduling process as a regulatory "black hole" after their FDA-approved drugs were put on hold pending a final DEA scheduling decision.
Without receiving final approval from DEA, a drug isn't allowed to be marketed—something some legislators are now attempting to fix.
Now DEA has given its final and widely expected approval to Merck to market its drug under the Schedule IV controls of the CSA.
In a 27 August 2014 final rule, DEA said it had placed suvorexant, "including its salts, isomers and salts of isomers" into Schedule IV of the CSA.
"This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule IV controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities, or possess), or propose to handle suvorexant," DEA said.
The final rule will go into effect in 30 days, at which time Merck will be allowed to market the drug. FDA's approval notice for Belsomra had already described the drug as a Schedule IV substance.
In a 13 August 2014 statement, Merck said it expects the drug to be available in "late 2014 or early 2015."
Tags: Merck, Suvorecant, Belsomra, DEA, Schedule IV, CSA, Controlled Substances Act