Nippon Shinyaku to Market Fintepla in Japan for Treatment of Dravet Syndrome Seizures

Zogenix‘s investigational therapy Fintepla (ZX008) to treat epileptic seizures associated with Dravet syndrome will be marketed in Japan by pharmaceutical company Nippon Shinyaku.

Fintepla is a low-dose oral solution of fenfluramine hydrochloride, a compound derived from the stimulant amphetamine. Patients take it with other epileptic treatments to reduce the frequency of seizures. Zogenix is also investigating Fintepla for the treatment of Lennox-Gastaut syndrome (LGS).

“Nippon Shinyaku’s expertise and commitment to rare diseases make the company an attractive strategic distribution partner for Fintepla,” Stephen J. Farr, PhD, president and CEO of Zogenix said in a press release.

“Given the current limited available treatments for Dravet syndrome and LGS in Japan, we look forward to working with Nippon Shinyaku to advance Fintepla as a potential new treatment option for patients and their families,” Farr added.

Previous clinical data from a prospective, post-hoc analysis of two identical Phase 3 studies — ZX008-1501 and ZX008-1502 — showed that treatment with Fintepla over a period of 14 weeks led to a substantial reduction in convulsive seizure frequency in children and young adults with Dravet syndrome when compared with a placebo.

Also, results from the Phase 3 Study 1504 (NCT02926898) showed that after 14 weeks of treatment with Fintepla, patients achieved meaningful improvements in behavior, emotion, and cognitive regulation compared with those on placebo.

Data from an ongoing Phase 3 open-label extension study (NCT02823145) testing the safety of long-term tretament with Fintepla (for up to 21 months) has shown that the therapy is tolerable and safe over extended periods of time, with no patients developing cardiac or pulmonary complications associated with the treatment.

“Intractable and rare diseases is one of our most important areas of focus. We look forward to further contributing to the well-being of patients and their families, and addressing unmet medical needs in Dravet syndrome and LGS by working with Zogenix to bring Fintepla to market in Japan,” said Shigenobu Maekawa, president of Nippon Shinyaku.

Zogenix will continue to lead the therapy’s clinical development program, including the ongoing Phase 3 open-label extension study.

The company recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application to the European Medicines Agency (EMA) for Fintepla to treat seizures associated with Dravet syndrome. New drug applications are also planned in Japan for Dravet syndrome and LGS. EMA is currently reviewing the NDA and an FDA decision is expected soon.

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