Fintepla® (fenfluramine) oral solution is no longer listed as a controlled substance, according to the Drug Enforcement Administration (DEA).
Fintepla is approved for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older. The descheduling of the medication, which contains the amphetamine derivative fenfluramine, means that all federal controlled substance restrictions have been removed for the treatment. The change will allow prescribers to write prescriptions for a full year’s supply and send prescriptions electronically to pharmacies.
“We are pleased that Fintepla, which has a unique mechanism of action different from and complementary to other antiseizure medications, has been descheduled and can help even more patients and families living with Dravet syndrome and Lennox-Gastaut syndrome manage the impact and burden of seizures,” said Brad Chapman, Head of US Epilepsy and Rare Syndromes, UCB. “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.”
The DEA change in scheduling for Fintepla is immediate. The company has filed a labeling supplement with the Food and Drug Administration to remove the Schedule IV designation from the Fintepla prescribing information.
This article originally appeared on MPR
References:
UCB announces Fintepla® (fenfluramine) oral solution is now descheduled and is no longer listed as a controlled substance. News release. UCB. Accessed April 17, 2023. https://www.prnewswire.com/news-releases/ucb-announces-fintepla-fenfluramine-oral-solution-is-now-descheduled-and-is-no-longer-listed-as-a-controlled-substance-301798777.html.