Zogenix new antiepileptic drugs reach the main end point of phase 3

Recently, zogenix company, which is committed to the development of rare disease therapy, announced that its oral fluoroamphetamine fintepla (zx008) reached the main research end point in the critical phase 3 trial for Lennox Gastaut syndrome (LGS) patients Compared with the placebo group, the frequency of seizures in the fintepla group was significantly lower than that at baseline LGS usually occurs between 3 and 5 years old There are many causes, including brain malformation, severe head injury, central nervous system infection, hereditary neurodegenerative diseases, or metabolic diseases Most LGS children have some degree of mental retardation, stunting and abnormal behavior LGS patients usually have a variety of seizure types, including spastic seizures, which lead to frequent falls and injuries Resistance to antiepileptic drugs (AEDs) is common in LGS patients They need new antiepileptics to manage seizures effectively The fintepla developed by zogenix is a liquid form of fluoroamphetamine It can reduce the frequency of epileptic seizures by regulating serotonin mechanism and sigma-1 receptor activity Previously, fintepla was awarded orphan drug qualification by FDA and European drug administration to treat LGS patients At present, the new drug application (NDA) of fintepla for the treatment of epilepsy related to Dravet syndrome has obtained the priority review qualification of FDA, and it is expected to receive the reply before March 25 this year The key phase 3 trial, called study 1601, was divided into two parts The first part aims to evaluate the safety and efficacy of fintepla in current antiepileptic therapy for LGS patients, involving 263 patients aged 2 to 35 years These patients have been treated with one or more antiepileptic drugs, but the disease has not been well controlled Their median baseline frequency of seizures was 77 per month Four weeks after the baseline attack frequency was determined, the randomized patients were adjusted to the treatment dose within the titration period of two weeks, followed by a fixed dose maintenance period of 12 weeks Patients who completed part 1 are eligible for Part 2 clinical trials The second part is a 12-month open label extension study to assess the long-term safety and effectiveness of fintepla ▲ study 1601 reached the main end point (picture source: reference [2]) The results of this trial showed that the frequency of seizures in LGS patients in the fintepla treatment group was significantly lower than that at baseline, the primary end point of this trial The median frequency of seizures was reduced by 26.5% in the 0.7 mg / kg / day fintepla group compared with 7.8% in the placebo group In addition, patients in the fintepla treatment group also showed improvement at multiple secondary endpoints reference material: [1] Zogenix Announces Positive Top-line Results from Global Pivotal Phase 3 Trial of FINTEPLA® for the Treatment of Lennox-Gastaut Syndrome，Retrieved February 07, 2020, from https://zogenixinc.gcs-web.com/news-releases/news-release-details/zogenix-announces-positive-top-line-results-global-pivotal-phase [2] Zogenix Conference Call to Discuss Positive Top-line Results from Global Pivotal Phase 3 Trial of FINTEPLA® for the Treatment of Lennox-Gastaut Syndrome，Retrieved February 07, 2020, from https://viavid.webcasts.com/viewer/event.jsp?ei=1283978&tp_key=4d9a85d74c Original title: express delivery significantly reduces seizure frequency, and new antiepileptic drugs reach the main end point of phase 3 Note: the original text has been deleted A kind of