Sodium oxybate ER is under clinical development by Avadel Pharmaceuticals and currently in Phase III for Type 2 Narcolepsy (Narcolepsy without Cataplexy). According to GlobalData, Phase III drugs for Type 2 Narcolepsy (Narcolepsy without Cataplexy) does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Sodium oxybate ER LoA Report. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Sodium oxybate ER overview
Sodium oxybate (Lumryz) is a central nervous depressant. It is formulated as extended release solution for oral administration. sodium oxybate for is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. The drug candidate is administered orally. The drug candidate is formulated as extended release suspension.
Sodium oxybate is under development for the treatment of cataplexy or EDS in the pediatric narcolepsy population, type 1 and type 2 narcolepsy and idiopathic hypersomnia. The drug candidate is administered through oral route as a suspension. It acts by targeting (gamma-aminohydroxybutyric acid-B) GABAB receptor. The development of the drug candidate is based on Micropump platform technology.
Avadel Pharmaceuticals overview
Avadel Pharmaceuticals (Avadel) is a biopharmaceutical company that focuses on the development of products for the treatment of narcolepsy. Its marketed product Lumryz, is an FDA-approved, once-at-bedtime oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. The company’s products are developed on its proprietary polymer-based technologies: Micropump, an oral sustained release microparticles platform, LiquiTime, a Micropump – derived platform for liquid oral products, and Medusa that enables controlled release of injectables. It sells products in the US and Ireland. The company operates in St. Louis, Missouri in the US. Avadel is headquartered in Dublin, Ireland.
For a complete picture of Sodium oxybate ER’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
