The FDA has approved FINTEPLA® (fenfluramine) oral solution, CIV, for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age and older. FINTEPLA is already approved as a treatment for Dravet syndrome in patients 2 years of age and older.
Please note that FINTEPLA is available only through the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program due to the risk of valvular heart disease and pulmonary arterial hypertension.
Please see additional IMPORTANT SAFETY INFORMATION, including Boxed Warning, below.
Zogenix Central’s patient-focused model of care offers every family and their healthcare provider a dedicated Care Coordinator—a nurse trained in Dravet syndrome, Lennox-Gastaut syndrome, and FINTEPLA—who will remain constant throughout their entire FINTEPLA treatment journey. In addition, caregivers have 24/7/365 access to our Zogenix Central pharmacy team.
- Please see the UCB press release regarding FDA-approval and FINTEPLA® Prescribing Information
- For additional safety and efficacy information, click https://www.fintepla.com/about-fintepla/results-with-fintepla/
- If an eligible patient or caregiver is looking for financial assistance, please visit Fintepla affordability resources
For more information, please contact Zogenix Central at 1-888-ZOGENIX (1-888-964-3649) or visit the website: Zogenix Central | Fintepla
FINTEPLA has demonstrated efficacy in the most difficult to treat seizure types, including drop seizures, which cause a person to suddenly lose muscle tone, become limp, and fall to the ground, with a high likelihood of injury. FINTEPLA has a mechanism of action different from and complementary to current seizure medications, and it can be used with no disruptions to current antiseizure regimens. In the global placebo-controlled Phase 3 clinical study, there were numerically greater improvements on the Clinical Global Impressions scale (CG-I) in patients living with LGS when taking FINTEPLA.