DEA lifts Fintepla’s Schedule IV controlled substance status

UCB to ask FDA to strike Schedule IV designation from therapy's label

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by Steve Bryson, PhD |

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Note: This article was updated April 21, 2023, to reflect that Fintepla was originally classified a Schedule IV controlled substance due to its low risk of abuse or misuse. A risk evaluation and mitigation strategy established by Zogenix that limits Fintepla’s access due to links with cardiovascular-related side effects remains in place.

Fintepla (fenfluramine), an add-on anti-seizure therapy for Dravet syndrome, is no longer considered a Schedule IV controlled substance by the U.S. Drug Enforcement Administration (DEA).

UCB, which markets the medicine, has now asked the U.S. Food and Drug Administration (FDA) to remove the designation from the therapy’s label.

According to the DEA, Schedule IV drugs are placed due to “low to potential for abuse or dependence.” This designation limited access to the FDA-approved medication for patients with Dravet and with Lennox-Gastuat syndrome. FINTEPLA is no longer considered a controlled substance. Separate from descheduling, the FDA-required REMS program for FINTEPLA, including ongoing cardiac monitoring, remains in place.

Once the change is made, Fintepla can be prescribed for an entire year instead of six months, as it is now. The DEA ruling also allows prescriptions to be sent to pharmacies electronically.

“We are pleased that Fintepla, which has a unique mechanism of action different from and complementary to other anti-seizure 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,” Brad Chapman, UCB’s head of U.S. epilepsy and rare syndromes, said in a press release. “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.”

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Frequent and lasting seizures beginning in infancy are the most common symptom of Dravet, a rare form of epilepsy. Other symptoms include developmental, behavioral, and motor challenges, which severely impact the quality of life for patients, families, and caregivers.

Fintepla was initially developed by Zogenix before being acquired by UCB in 2022 and is intended to be taken with other anti-epileptic treatments to reduce the frequency of seizures.

Its approval was based on data from Phase 3 clinical studies and an open-label extension study that showed it significantly reduced the number of monthly seizures not controlled by existing anti-seizure medications. The most common side effects reported were diarrhea, fever, nose and throat inflammation, and reduced appetite.

Soon after its approval, Zogenix established an FDA-required risk evaluation and mitigation strategy (REMS) program for Fintepla due to its association with serious side effects, including valvular heart disease and pulmonary arterial hypertension.

This safety program required that patients receiving the medication be enrolled in REMS and those prescribing it and pharmacies distributing it be certified. Patients taking Fintepla must be monitored for heart abnormalities — an echocardiogram before treatment, every six months during treatment, and three to six months after stopping.

With the DEA’s ruling, all federally controlled substance restrictions have now been removed from the medication and the process of updating pharmaceutical listings in the states holding licenses has begun.

“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 of the Dravet Syndrome Foundation. “We are pleased to hear of the descheduling of Fintepla, which will remove roadblocks to access and ease caregiver burden.”