After Nearly a Year in Regulatory 'Black Hole,' Arena Gets DEA's Approval for Weight Loss Pill Belviq
Posted 07 May 2013 | By
After a lengthy wait, the Drug Enforcement Administration (DEA) has announced the classification of lorcaserin, better known as Arena Pharmaceuticals' weight loss drug Belviq, as a Schedule IV controlled substance under the Controlled Substances Act (CSA).
The announcement comes after months of waiting by Arena. When Belviq was approved in June 2012, it was heralded as the start of a sea change in the regulatory paradigm for obesity drugs. Prior to its approval, no obesity drug had been approved in 13 years.
But despite that approval-which came with at least six postmarketing studies meant to assess the drug's potential to cause heart attack and stroke-the drug has been stuck in limbo, unable to get to market without first obtaining DEA approval.
That's because the drug has "central nervous system hallucinogenic properties," DEA explained in its Federal Register posting. Just days after the drug's 2012 approval, the US Department of Health and Human Services (DHHS) recommended that the drug be placed into Schedule IV of the CSA-the second-least restrictive of the scheduling classes and one that reflects a relatively minor potential for abuse.
Such substances meet three criteria: The drug has a low potential for abuse, has a clear medical use, and abuse of the drug has relatively minor adverse health effects.
But despite DHHS' recommendation, the Belviq decision was left to stagnate for the better part of a year. In an interview in The Pink Sheet Dailyin April 2013, Eisai CEO Lonnel Coats, whose company is also involved in the marketing of Belviq, said the DEA scheduling process amounted to a "black hole."
"We have very little insight into that hole," Coats added. That process, he explained, stands in opposition to that of the US Food and Drug Administration, which he said had more favorable levels of transparency in the form of timelines and set expectations.
DEA's approval of Belviq was based on an eight-factor analysis of its abuse potential, the agency said in its Federal Register posting, as well as 71 comments on its proposed rule. The vast majority of those comments favored the proposed scheduling classification for the drug, the agency noted.
Petitioners to DEA: Hurry Up
Interestingly, 32 comments received by the agency were unrelated to the scheduling classification itself, but rather expressed their opinion that DEA was taking too long.
"Generally, the commenters indicated that the scheduling action should be expedited due to epidemic levels of obesity in the United States and the absence of any weight loss drugs on the market with lorcaserin's novel mechanism of action. Some commenters stated that the review conducted by FDA was sufficient to justify that lorcaserin be controlled expeditiously," DEA explained.
An additional eight commenters said that in light of the delays, DEA should allow Belviq to be marketed as soon as the final scheduling rule was posted in the Federal Register. Those petitioners are likely to be disappointed, as DEA has announced that its approval of Belviq will take place 30 days after the notice's publication in the Federal Register.
"DEA believes that providing 30 days for this rule to become effective is both expeditious and sufficient to allow handlers to apply for registration with DEA and to comply with regulatory requirements for handling Schedule IV controlled substances," the agency explained. "DEA believes that the clinical indications for lorcaserin do not support the waiver of the 30-day period."
Under Schedule IV, Arena will have to make sure the drug is appropriately packaged, kept track of through inventory and records and subject to appropriate prescribing. Criminal liabilities also exist for the drug.
The DEA decision hasn't been the only setback to Arena. The company withdrew its Belviq marketing authorization application (MAA) in the EU on 3 May 2013, citing the inability to resolve what it called "major objections" from the Committee for Medicinal Products for Human use.
DEA Scheduling Decision on Belviq