Gamma-Hydroxybutyrate Compositions Having Improved Pharmacokinetics In The Fed State
Patent No. US10925844 (titled "Gamma-Hydroxybutyrate Compositions Having Improved Pharmacokinetics In The Fed State") was filed by Rtw Investments Lp on Aug 7, 2020.
What is this patent about?
’844 is related to the field of pharmaceutical compositions, specifically those used to treat narcolepsy, cataplexy, and excessive daytime sleepiness. Current treatments, like immediate-release sodium oxybate (Xyrem®), require strict adherence to dosing schedules relative to meals, as food significantly reduces the drug's bioavailability. This creates challenges for patients, impacting compliance, efficacy, and safety, and potentially increasing the risk of abuse.
The underlying idea behind ’844 is to formulate a gamma-hydroxybutyrate composition that can be administered less than two hours after eating without compromising its effectiveness. This is achieved through a modified-release mechanism that minimizes the impact of food on the drug's absorption, allowing for a more flexible dosing schedule and improved patient outcomes. The key is to control the release of the drug so that food intake has a minimal effect on the overall bioavailability.
The claims of ’844 focus on an oral pharmaceutical composition containing gamma-hydroxybutyrate in a unit dose designed for administration less than two hours after eating. The independent claims cover the composition itself, emphasizing its suitability for use without the strict meal-timing constraints of existing treatments. This includes formulations where the absorption of the active ingredient is not substantially changed by the presence of food.
The invention works by utilizing a combination of immediate-release and modified-release components. The immediate-release portion provides an initial dose, while the modified-release portion delays the release of the remaining drug until it reaches the small intestine, where food has less of an impact on absorption. This approach aims to maintain a consistent pharmacokinetic profile regardless of meal timing, improving the drug's predictability and effectiveness.
This formulation differs from prior approaches, such as Xyrem®, which requires a strict two-hour fasting period before dosing. By mitigating the food effect, ’844 offers a more convenient and reliable treatment option for patients with narcolepsy and related conditions. The goal is to achieve a similar or improved bioavailability compared to existing treatments, even when administered shortly after eating, while also potentially reducing adverse events due to a more controlled release profile and a single daily dose.
How does this patent fit in bigger picture?
Technical landscape at the time
In the late 2010s when ’844 was filed, modified release formulations were at a time when achieving specific pharmacokinetic profiles was typically implemented using various combinations of excipients and coatings. Oral drug delivery systems commonly relied on immediate release or extended release mechanisms rather than complex multi-phasic release profiles. Hardware or software constraints made precise control over drug release rates non-trivial.
Novelty and Inventive Step
The claims were rejected in a non-final office action. The examiner provisionally rejected claims under 35 U.S.C. 101 for double patenting over a copending application. Claims 1 and 6 were rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2011/119839 A1. Claim 7 was rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2018/015563 A1. The prosecution record does NOT describe the technical reasoning or specific claim changes that led to allowance.
Claims
This patent contains 29 claims, with independent claims 1 and 29 directed to an oral pharmaceutical composition comprising gamma-hydroxybutyrate in a unit dose suitable for administration less than two hours after eating. The dependent claims generally elaborate on the characteristics of the composition, such as its administration timing, release properties, pharmacokinetic profiles, and comparisons to existing formulations.
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Date
Description
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US10925844
- Application Number
- US16987510
- Filing Date
- Aug 7, 2020
- Status
- Granted
- Expiry Date
- Feb 28, 2040
- External Links
- Slate, USPTO, Google Patents