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Sublingual administration of riluzole

A technology of riluzole and drug administration, which is applied in the field of sublingual administration of riluzole, to achieve the effect of reducing side effects and weakening abnormal liver function

Inactive Publication Date: 2018-02-23
BIOHAVEN PHARMA HLDG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is currently no sublingual formulation of riluzole or the use of riluzole, although it has been used for more than 20 years

Method used

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  • Sublingual administration of riluzole
  • Sublingual administration of riluzole
  • Sublingual administration of riluzole

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] A 51-year-old man received four doses of riluzole.

[0089] (1) Riluzole in a normal oral administration form was used as a comparator. A standard 50 mg riluzole tablet (not a tablet of the present invention) was crushed and administered into the oral cavity for 40 seconds to allow transmucosal and / or oral absorption. This is not sublingual or buccal administration. No acute or chronic effects on the neuropsychiatric field. More specifically, there was no effect on mood, anxiety or behaviour. Prominent oral numbness was noted. Within the first minute, numbness spreads throughout the mouth, including the back of the tongue and lips, causing perioral paresthesias. The effect is moderate and peaks within 4 minutes. The effect lasts for up to 80 minutes. The effect started to decline after 15 minutes, was considered mild after 40 minutes, and minimal after 80 minutes. All effects are limited to the aforementioned local oral sensations.

[0090] (2) In addition, the ...

Embodiment 2

[0096] A 43-year-old man took riluzole twice.

[0097] (1) Oral administration: about 50 mg of uncrushed riluzole tablets (not the formulation of the present invention) were placed on the tongue of the subject. But no psychotropic effects were reported after immediate application, and subjects reported numbness in the area of ​​topical application that spread rapidly throughout the oral cavity. The numbness lasted 20 minutes. No sense of mood or behavior was reported. The numbness is strong and annoying.

[0098] (2) Sublingual administration: about 20 mg of riluzole sublingual preparation was placed under the tongue of the subject for about 30 seconds. Within about 20 minutes, subjects reported onset of beneficial psychoactive effects, including feelings of relaxation, calm, and less anxiety. Subjects also reported feeling alert. These psychoactive effects or sensations lasted about 90 minutes. The subject noted that his gastrointestinal tract felt "calmed" and his prev...

Embodiment 3

[0101] A 50-year-old man took a sublingual formulation of riluzole.

[0102] A sublingual formulation of about 5 mg of riluzole was placed under the subject's tongue for approximately 20 seconds until the formulation was completely dissolved. Again, in other subjects who received sublingual administration, unexpected psychoactive effects occurred shortly after dosing. Within 20 to 30 minutes, the subject reported the onset of beneficial psychoactive effects, and he reported a feeling of relaxation and calm.

[0103] About 7 minutes after dosing, the subject reported numbness in his mouth and the top of his tongue, which peaked at about 7 minutes and then completely disappeared about 21 minutes later.

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Abstract

Disclosed is sublingual administration of riluzole. In particular, a method for treating a neuropsychiatric disorder or symptom by administering a sublingual formulation of riluzole is provided. In addition, a method of relieving or reducing oral pain using the sublingual formulation of riluzole is disclosed.

Description

[0001] References to related applications [0002] This application is a continuation-in-part of US Provisional Application Serial No. 62 / 083,068 filed on November 21, 2014, the disclosure content of which is fully incorporated into this application. technical field [0003] The present invention relates to sublingual administration of riluzole and methods of using sublingual formulations of riluzole. Background technique [0004] Riluzole (6-(trifluoromethoxy)benzothiazol-2-amine) is a drug that has been used to treat amyotrophic lateral sclerosis (ALS). More recently, riluzole has been shown to have other clinical benefits. For example, riluzole administered orally twice daily at a total dose of 100 mg can alleviate or treat neuropsychiatric symptoms and conditions, such as mood disorders, anxiety disorders, treatment-resistant depression, obsessive-compulsive anxiety, and the like. [0005] However, such therapeutic neuropsychiatric effects via current oral dosing are ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/08A61K9/20A61K31/428
CPCA61K9/0056A61K9/006A61K9/08A61K9/20A61K31/428A61P1/02A61P25/00
Inventor V·科里克R·M·伯曼
Owner BIOHAVEN PHARMA HLDG CO LTD
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