FT218 (Sodium oxybate), Emerging Drug Insight and Market Forecast - 2032

“FT218 (Sodium oxybate), Emerging Drug Insight and Market Forecast - 2032” report provides comprehensive insights about FT218 (Sodium oxybate) for Excessive Daytime Sleepiness (EDS) in the 7MM. A detailed picture of the FT218 (Sodium oxybate) for Excessive Daytime Sleepiness (EDS) 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 FT218 (Sodium oxybate) for Excessive Daytime Sleepiness (EDS) . 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 FT218 (Sodium oxybate) market forecast, analysis for Excessive Daytime Sleepiness (EDS) in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in Excessive Daytime Sleepiness (EDS) .

Drug Summary

Avadel's FT218 is an investigational, once-nightly formulation of sodium oxybate using a proprietary micropump technology for extended-release oral suspension in treating Excessive Daytime Sleepiness (EDS) and cataplexy in patients suffering from narcolepsy. Sodium oxybate is indicated for the treatment of EDS and cataplexy in patients with narcolepsy. The currently marketed product, an immediate-release (IR) sodium oxybate, is required to be taken twice nightly: at bedtime and 2.5-4 h later, thus requiring patients to awaken in the middle of the night.

Once-nightly FT218 has been granted Orphan Drug designation by the US FDA for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that once-nightly FT218 might be clinically superior to a sodium oxybate formulation already approved by the FDA for the same indication. In particular, once-nightly FT218 may be safer due to ramifications associated with the dosing regimen of the previously-approved, twice-nightly product. Avadel has patent protection till 2037.

In April 2020, the company announced the topline data from the Phase III clinical trial. Among the three co-primary endpoints of the study, FT218 demonstrated statistically significant and clinically meaningful results in EDS, the clinician's overall assessment of the patient's functioning, and a reduction in cataplexy attacks for all three evaluated doses when compared to placebo. Avadel is currently evaluating the long-term safety and tolerability of FT218 in the open-label RESTORE clinical study, and the NDA is under FDA review.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the FT218 (Sodium oxybate) description, mechanism of action, dosage and administration, research and development activities in Excessive Daytime Sleepiness (EDS).
• Elaborated details on FT218 (Sodium oxybate) regulatory milestones and other development activities have been provided in this report.
• The report also highlights the FT218 (Sodium oxybate) research and development activity in Excessive Daytime Sleepiness (EDS) in detail across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around FT218 (Sodium oxybate).
• The report contains forecasted sales of FT218 (Sodium oxybate) for Excessive Daytime Sleepiness (EDS) till 2032.
• Comprehensive coverage of the late-stage emerging therapies for Excessive Daytime Sleepiness (EDS).
• The report also features the SWOT analysis with analyst views for FT218 (Sodium oxybate) in Excessive Daytime Sleepiness (EDS).

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by a 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.

FT218 (Sodium oxybate) Analytical Perspective

In-depth FT218 (Sodium oxybate) Market Assessment

This report provides a detailed market assessment of FT218 (Sodium oxybate) in Excessive Daytime Sleepiness (EDS) 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.

FT218 (Sodium oxybate) Clinical Assessment

The report provides the clinical trials information of FT218 (Sodium oxybate) in Excessive Daytime Sleepiness (EDS) covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

• In the coming years, the market scenario for Excessive Daytime Sleepiness (EDS) 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 FT218 (Sodium oxybate) dominance.
• Other emerging products for Excessive Daytime Sleepiness (EDS) are expected to give tough market competition to FT218 (Sodium oxybate) 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 FT218 (Sodium oxybate) in Excessive Daytime Sleepiness (EDS).
• Our in-depth analysis of the forecasted sales data of FT218 (Sodium oxybate) from 2022 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the FT218 (Sodium oxybate) in Excessive Daytime Sleepiness (EDS).

 

Key Questions Answered

• What is the product type, route of administration and mechanism of action of FT218 (Sodium oxybate)?
• What is the clinical trial status of the study related to FT218 (Sodium oxybate) in Excessive Daytime Sleepiness (EDS) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the FT218 (Sodium oxybate) development?
• What are the key designations that have been granted to FT218 (Sodium oxybate) for Excessive Daytime Sleepiness (EDS)?
• What is the forecasted market scenario of FT218 (Sodium oxybate) for Excessive Daytime Sleepiness (EDS)?
• What are the forecasted sales of FT218 (Sodium oxybate) in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What are the other emerging products available in Excessive Daytime Sleepiness (EDS) and how are they giving competition to FT218 (Sodium oxybate) for Excessive Daytime Sleepiness (EDS)?
• Which are the late-stage emerging therapies under development for the treatment of Excessive Daytime Sleepiness (EDS)?