Methods for treating hypersomnolence
Inventors
Bäckström, Torbjörn • Doverskog, Magnus • Johansson, Maja • Wasling, Pontus
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10278977-B2
Publication Date
2019-05-07
Expiration Date
Abstract
There is provided a method of treatment of hypersomnolence comprising administering the steroidal compound 3α-ethynyl-3β-hydroxy-5α-androstan-17-one oxime, or a pharmaceutically acceptable salt thereof, to a subject in need of such treatment.
Core Innovation
The disclosed invention provides methods for treating hypersomnolence by administering a therapeutically effective amount of 3α-ethynyl-3β-hydroxy-5α-androstan-17-one oxime, or a pharmaceutically acceptable salt thereof, to a subject in need of such treatment. The treatment is framed around promoting wakefulness for hypersomnolence conditions.
Hypersomnolence includes idiopathic hypersomnia and other subtypes, and the document further includes conditions associated with GABA_A-receptor-mediated hypersomnia. The compound is connected to GABA_A receptor modulation, describing positive allosteric modulation and referencing an endogenous modulator in cerebrospinal fluid.
The description further provides embodiments involving pharmaceutically acceptable salts, including hydrochloride and sodium salt, and mentions isotopically labeled or deuterated compounds. The document includes formulation and route-of-administration embodiments and identifies evaluation approaches and endpoints such as Epworth Sleepiness Scale (ESS), Maintenance of Wakefulness Test (MWT), and Clinical Global Impression (CGI).
Claims Coverage
One independent claim is provided, with dependent claims refining the treated hypersomnolence condition set and specifying a mechanistic cause and a formulation context. Overall, the claim set centers on administration of 3α-ethynyl-3β-hydroxy-5α-androstan-17-one oxime (or a pharmaceutically acceptable salt) to treat hypersomnolence.
Treating hypersomnolence by administering the oxime or pharmaceutically acceptable salt
A method for the treatment of hypersomnolence comprising administering a therapeutically effective amount of 3α-ethynyl-3β-hydroxy-5α-androstan-17-one oxime, or a pharmaceutically acceptable salt thereof, to a subject in need of such treatment.
GABA_A-receptor-mediated hypersomnia treatment
The method further specifies that hypersomnolence is caused by GABA_A receptor-mediated hypersomnia.
Hypersomnolence disorder selection across multiple named disorders
The method applies to hypersomnolence disorders selected from idiopathic hypersomnia, recurrent hypersomnia, narcolepsy, shift work sleeping disorder, endozepine induced-recurrent stupor, and amphetamine-resistant hypersomnia.
Narcolepsy type 2 indication
The method applies to treating hypersomnolence disorder that is specifically type 2 narcolepsy.
Narcolepsy type 1 indication
The method is further limited to use for treating hypersomnolence disorder type 1 narcolepsy.
Pharmaceutical composition administration with optional adjuvants
The method further includes administering 3α-ethynyl-3β-hydroxy-5α-androstan-17-one oxime as part of a pharmaceutical composition, optionally mixed with pharmaceutically acceptable adjuvants, diluents, or carriers.
The independent claim covers treating hypersomnolence via administration of 3α-ethynyl-3β-hydroxy-5α-androstan-17-one oxime (or a pharmaceutically acceptable salt) to a subject. Dependent claims narrow coverage by specifying GABA_A-receptor-mediated hypersomnia, by selecting among particular hypersomnolence disorders, by restricting to narcolepsy type 1 or type 2, and by administering the oxime as part of a pharmaceutical composition with optional adjuvants, diluents, or carriers.
Stated Advantages
Promoting wakefulness for hypersomnolence treatment.
Documented Applications
Treatment of hypersomnolence, including idiopathic hypersomnia and other subtypes, in a planned double-blind randomized placebo-controlled crossover phase 2a clinical study with efficacy endpoints.
Interested in licensing this patent?