Fenfluramine No Longer Listed as Controlled Substance for Seizure Disorders

The US Drug Enforcement Administration (DEA) published a final rule stating that fenfluramine oral solution (Fintepla; UCB, Atlanta, GA), which is used to treat seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older, is no longer subject to the Controlled Substances Act (CSA).

The DEA rule means that all federally controlled substance restrictions have been removed for fenfluramine. The manufacturer of the drug will now begin the process of updating the compendia in states where it holds licensure. When this process is completed, in most cases prescribers will be able to write a prescription for a full year’s supply of the drug instead of 6 months, the current amount allowed.  

“Physicians will now have the option to issue an electronic prescription for Fintepla rather than requiring patients to obtain a written prescription to access this important therapy, which may be simpler and a better experience for all involved,” said Brad Chapman, Head of US Epilepsy and Rare Syndromes, UCB. “It is vitally important that our patient community has easy access to medicines that potentially reduce life-threatening and deadly seizures,” said Mary Anne Meskis, Executive Director, Dravet Syndrome Foundation.

Fenfluramine was approved by the Food and Drug Administration for the treatment of DS in patients 2 years of age and older in June 2020, and for the treatment of LGS in patients 2 years of age and older in March 2022. UCB provides important safety information in a black box warning about flenfluramine, noting that problems with the valves in the heart (valvular heart disease) and high blood pressure in the arteries of the lungs (pulmonary arterial hypertension) have been associated with fenfluramine.