Avadel Pharmaceuticals has been granted a patent for modified release formulations of gamma-hydroxybutyrate (GHB) that enhance dissolution and pharmacokinetic properties. The patent includes a method for treating narcolepsy-related cataplexy or excessive daytime sleepiness using a specific GHB dosage regimen. GlobalData’s report on Avadel Pharmaceuticals gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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According to GlobalData’s company profile on Avadel Pharmaceuticals, was a key innovation area identified from patents. Avadel Pharmaceuticals's grant share as of June 2024 was 52%. Grant share is based on the ratio of number of grants to total number of patents.
Gamma-hydroxybutyrate formulations for treating narcolepsy symptoms
The granted patent US11986451B1 outlines a method for treating narcolepsy-related cataplexy or excessive daytime sleepiness in human patients using a gamma-hydroxybutyrate (GHB) formulation. The treatment begins with an initial oral dosage equivalent to 4.5 g of sodium oxybate, administered once per night. This formulation includes both immediate-release (IR) and modified-release (MR) components, which may contain the same or different GHB. The method involves a systematic up-titration of the dosage in increments of 1.5 g of sodium oxybate, with the patient maintaining each new dosage for at least one week before any further adjustments. The effective dosage range is specified to be between 6 g and 9 g of sodium oxybate per night, with specific claims detailing the maintenance of these dosages over several weeks.
Additionally, the patent claims emphasize the importance of not exceeding a nightly dosage equivalent to 9 g of sodium oxybate. The up-titration process can extend over a period of three to eight weeks, depending on the patient's response. The method also allows for the potential administration of a stimulant alongside the GHB formulation. The claims provide a structured approach to dosage initiation, titration, and maintenance, ensuring that patients receive a tailored treatment regimen aimed at alleviating symptoms associated with narcolepsy.
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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies
