Delisted "old drug" gets new FDA approval for breakthrough therapy to treat rare childhood epilepsy

26, Zogenix announced that the U.SFDA has approved the listing of an oral solution for Fintepla (fenfluramine, fenfluramine) to treat seizures associated with Dravet syndrome in patients 2 years and olderFenfluramin was developed as an appetite-suppressing weight-loss drug back in the 1960s and was approved for sale in the United States in 1973However, subsequent studies have found that the drug is associated with primary pulmonary hypertension and heart valve disease in a small number of patientsAs a result, the drug was withdrawn from the U.Smarket in 1997Yesterday's approval allowed the "old medicine" to complete the "life-to-life" journeyDravet syndrome is a rare childhood seizure characterized by frequent and severe refractive seizures, associated hospitalizations and medical emergencies, significant developmental and motor disorders, and an increased risk of unexpected sudden deathThe Fintepla developed by Zogenix is a liquid form of low-dose fenfluraminIt can reduce the frequency of seizures by regulating the serotonin mechanism and sigma-1 receptor activityIt has been granted orphan drugs in the United States and the European Union, and has been awarded breakthrough therapies by the FDAThe FDA's approval is based on data from two randomized, double-blind, placebo-controlled Phase 3 clinical trials published in The Lancet and JAMA PfizerThe safety data comes from an open-label extended trial in which many patients receive Fintepla treatment for up to three yearsIn patients who failed to adequately control seizures with one or more anti-epileptic drugs, Fintepla significantly reduced the frequency of seizures per month compared to placeboData from the long-term open label extension trial, released in April, showed that more than 37 percent of patients had more than 75 percent fewer seizures when the median treatment lasted 445 daysIn addition, long-term safety studies did not detect primary pulmonary hypertension and heart valve disease in patientsDr Stephen J Farr, President and CEO of Zogenix, said, "FDA approval of Fintepla is an important milestone and we are proud to celebrate with patients and families with Dravet syndrome Fenfluramin has different pharmacologies than all other anticonvulsants We would like to thank our patients, their families and all those who have supported Fintepla's rigorous research and development program "
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