Fenfluramine Hydrochloride 2.2 mg/mL, 5 mg/mL Suppliers & Bulk Manufacturers

Available Forms: Oral Solution

Available Strengths: 2.2 mg/mL, 5 mg/mL

Reference Brands: Fintepla (USA, EU)

Category: Neurology

Fenfluramine hydrochloride is an antiepileptic medication used for the treatment of seizures associated with Dravet syndrome and Lennox–Gastaut syndrome in patients aged two years and older. It works by modulating serotonergic activity in the brain, helping reduce the frequency and severity of seizures. Fintepla is available as an oral solution in 2.2 mg/mL and 5 mg/mL strengths, with dosing customized to patient needs under strict monitoring programs.

Product Description:

Fenfluramine is a serotonin-releasing agent with additional activity at sigma-1 receptors. As an appetite suppressant it was withdrawn worldwide in 1997 after it was linked to cardiac valvulopathy and pulmonary arterial hypertension. It returned at much lower doses as an oral solution for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome, where controlled trials showed large reductions in convulsive seizure frequency in children whose epilepsy had resisted several other drugs.

Because of that history, echocardiography is required before treatment and at regular intervals during it and after stopping, and in the US it was launched under a restricted distribution programme. No valvulopathy or pulmonary hypertension was seen in the epilepsy trials at these doses, but monitoring remains mandatory. Decreased appetite and weight loss are common, as is somnolence. Stiripentol, commonly co-prescribed in Dravet syndrome, raises exposure, and the dose ceiling is lower when the two are combined.

Sourcing notes. The oral solution is an originator orphan product under exclusivity, with no generic. Fenfluramine was removed from US federal control in 2022, but it remains a Schedule IV psychotropic under the 1971 UN Convention and is controlled in many national lists, so import and export authorisations may apply. Supply is typically through authorised distribution or named-patient routes.