FINTEPLA Drug Insight

“FINTEPLA Market Size, Forecast, and Drug Insight – 2032” report provides comprehensive insights about FINTEPLA for Developmental and Epileptic Encephalopathy in the 7MM. A detailed picture of the FINTEPLA for Developmental and Epileptic Encephalopathy in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2019–2032 is provided in this report along with a detailed description of the FINTEPLA for Developmental and Epileptic Encephalopathy. The report provides insight about mechanism of action, dosage and administration, as well as research and development activity including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the FINTEPLA market forecast, analysis for Developmental and Epileptic Encephalopathy in the 7MM, descriptive analysis such as SWOT, analysts’ views, comprehensive overview of market competitors, and brief about emerging therapies in Developmental and Epileptic Encephalopathy.

Drug Summary

FINTEPLA (formerly known as ZX008) is an oral medication that is a low-dose solution of fenfluramine hydrochloride. It prevents the entry of calcium ions into nerve cells, lowering their over excitability and reducing seizure episodes. It also activates serotonin receptors, which contributes to the overall antiepileptic action.

Zogenix is evaluating the therapeutic drug in the Phase III stage of development after the successful completion of the Phase II clinical study. ZX008 for the treatment of LGS has previously been designated as an Orphan Drug by both the FDA and the European Commission. In February 2020, the company reported positive top-line results from the global Phase III clinical trial (Study 1601) of FINTEPLA for the treatment of LGS. FINTEPLA has been approved by the FDA, the EMA and got recently approved in Japan for the treatment of seizures associated with Dravet syndrome. The drug has been launched in Germany in Februray 2021. In addition, the company also intends to evaluate ZX008’s potential to treat additional indications in other rare pediatric-onset epileptic encephalopathies and related medical conditions in the future. The company is collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for rare genetic epilepsies.

In March 2022, Zogenix announced that new data from the company’s research and development program for FINTEPLA in LGS would be presented at the hybrid American Academy of Neurology (AAN) Annual Meeting 2022. Data from eight abstracts were presented at the American Epilepsy Society (AES) in December 2021.

In March 2019, Zogenix entered into an exclusive distribution agreement with Nippon Shinyaku to support the sales and distribution of the product in Japan. Additionally, the company evaluates FINTEPLA in other rare epileptic syndromes and diseases in Phase II and investigator-initiated Studies.

Dosage and Administration

•  The initial starting and maintenance dosage is 0.1 mg/kg twice daily, which can be increased weekly based on efficacy and tolerability.
•  Patients not on concomitant stiripentol: The maximum daily maintenance dosage of FINTEPLA is 0.35 mg/kg twice daily (maximum daily dosage of 26 mg).

Patients taking concomitant stiripentol plus clobazam: The maximum daily maintenance dosage of FINTEPLA for patients taking these medications is 0.2 mg/kg twice daily (maximum daily dosage of 17 mg).

Scope of the Report

The report provides insights into:

•  A comprehensive product overview including the FINTEPLA description, mechanism of action, dosage and administration, research and development activities in Developmental and Epileptic Encephalopathy.
•  Elaborated details on FINTEPLA regulatory milestones and other development activities have been provided in this report.
•  The report also highlights the FINTEPLA research and development activity in Developmental and Epileptic Encephalopathy details across the United States, Europe and Japan.
•  The report also covers the patents information with expiry timeline around FINTEPLA.
•  The report contains forecasted sales of FINTEPLA for Developmental and Epileptic Encephalopathy till 2032.
•  Comprehensive coverage of the late-stage emerging therapies for Developmental and Epileptic Encephalopathy.
•  The report also features the SWOT analysis with analyst views for FINTEPLA in Developmental and Epileptic Encephalopathy.

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

FINTEPLA Analytical Perspective by DelveInsight

• In-depth FINTEPLA Market Assessment

This report provides a detailed market assessment of FINTEPLA in Developmental and Epileptic Encephalopathy in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides forecasted sales data from 2022 to 2032.

• FINTEPLA Clinical Assessment

The report provides the clinical trials information of FINTEPLA for Developmental and Epileptic Encephalopathy covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights 

•  In the coming years, the market scenario for Developmental and Epileptic Encephalopathy is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.  
•  The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence FINTEPLA dominance.
•  Other emerging products for Developmental and Epileptic Encephalopathy are expected to give tough market competition to FINTEPLA and launch of late-stage emerging therapies in the near future will significantly impact the market.
•  A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of FINTEPLA in Developmental and Epileptic Encephalopathy.
•  Our in-depth analysis of the forecasted sales data of FINTEPLA from 2022 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the FINTEPLA in Developmental and Epileptic Encephalopathy.

Key Questions

•  What is the product type, route of administration and mechanism of action of FINTEPLA?
•  What is the clinical trial status of the study related to FINTEPLA in Developmental and Epileptic Encephalopathy and study completion date?
•  What are the key collaborations, mergers and acquisitions, licensing and other activities related to the FINTEPLA development?
•  What are the key designations that have been granted to FINTEPLA for Developmental and Epileptic Encephalopathy?
•  What is the forecasted market scenario of FINTEPLA for Developmental and Epileptic Encephalopathy?
•  What are the forecasted sales of FINTEPLA in the 7MM, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan? 
•  What are the other emerging products available in Developmental and Epileptic Encephalopathy and how are they giving competition to FINTEPLA for Developmental and Epileptic Encephalopathy?
•  Which are the late-stage emerging therapies under development for the treatment of Developmental and Epileptic Encephalopathy?