Avadel Pharmaceuticals has patented a modified release formulation of gamma-hydroxybutyrate for treating narcolepsy-related cataplexy or excessive daytime sleepiness. The method involves oral administration of specific dosages with immediate-release and modified-release portions. GlobalData’s report on Avadel Pharmaceuticals gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on Avadel Pharmaceuticals, was a key innovation area identified from patents. Avadel Pharmaceuticals's grant share as of May 2024 was 52%. Grant share is based on the ratio of number of grants to total number of patents.
Patent granted for modified release ghb formulation for narcolepsy
A recently granted patent (Publication Number: US11986451B1) discloses a method for treating narcolepsy-related cataplexy or excessive daytime sleepiness in human patients using a gamma-hydroxybutyrate (GHB) formulation. The method involves initiating treatment with a specific dosage of the GHB formulation, which includes both immediate-release (IR) and modified-release (MR) portions. The dosage is then up-titrated in increments equivalent to 1.5 g of sodium oxybate per night, with a maintenance period of at least a week before further adjustments. The treatment protocol emphasizes reaching an effective dosage range of 6 g to 9 g of sodium oxybate per night and ceasing any further up-titration upon achieving the desired effect.
Furthermore, the patent outlines a structured dosing regimen that involves increasing the once per night dosage over several weeks to reach optimal therapeutic levels. The method specifies maintaining each up-titrated dosage for a defined period before progressing to the next level, ensuring a gradual and controlled adjustment process. Additionally, the patent includes provisions for administering a stimulant to the patient and sets limits on the maximum dosage of sodium oxybate that can be administered. The method aims to provide a systematic approach to treating narcolepsy-related symptoms, focusing on individual patient needs and response to the GHB formulation.
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