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Compositions, devices, and methods for treatment of overdose and reward-based disorders

A formulation, volumetric technique, applied in the field of administration of an intranasal formulation of the opioid antagonist naltrexone, in the treatment of conditions such as opioid overdose and its symptoms and disorders such as alcohol use disorder

Pending Publication Date: 2021-10-29
AEGIS THERAPEUTICS LLC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although studies have shown that opioid antagonists such as naltrexone, given orally or by injection, can reverse opioid overdose and reduce alcohol consumption and its motor response, there remains a significant need for simple, rapid and compliant means to treat the condition

Method used

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  • Compositions, devices, and methods for treatment of overdose and reward-based disorders
  • Compositions, devices, and methods for treatment of overdose and reward-based disorders
  • Compositions, devices, and methods for treatment of overdose and reward-based disorders

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Experimental program
Comparison scheme
Effect test

Embodiment approach 3

[0026] Embodiment 3: according to the preparation described in embodiment 1 or embodiment 2, it further comprises:

[0027] Isotonic agent;

[0028] preservative;

[0029] stabilizer;

[0030] absorption enhancers; and

[0031]An amount of water sufficient to achieve a final volume of about 50 to about 250 μL, preferably about 50 to about 150 μL.

Embodiment approach 4

[0032] Embodiment 4: The formulation according to embodiment 3, comprising:

[0033] about 1 mg to about 3 mg of naltrexone or a pharmaceutically acceptable salt thereof;

[0034] about 0.1 mg to about 1.2 mg of an isotonic agent;

[0035] from about 0.001 mg to about 0.1 mg of a preservative;

[0036] from about 0.1 mg to about 0.5 mg of a stabilizer;

[0037] about 0.05 mg to about 2.5 mg of an absorption enhancer; and

[0038] An amount of water sufficient to achieve a final volume of about 50 to about 250 μL, preferably about 50 to about 150 μL.

Embodiment approach 5

[0039] Embodiment 5: The formulation according to embodiment 3, comprising:

[0040] about 1% to about 3% naltrexone or a pharmaceutically acceptable salt thereof;

[0041] about 0.1% to about 1.2% isotonic agent;

[0042] from about 0.001% to about 0.1% preservatives;

[0043] from about 0.1% to about 0.5% stabilizer;

[0044] From about 0.05% to about 2.5% absorption enhancers.

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Abstract

Drug products adapted for nasal delivery, comprising a device filled with a pharmaceutical composition comprising naltrexone are provided. Formulations and methods of treating alcohol use disorder and related conditions with the drug products are also provided.

Description

[0001] Cross References to Related Applications [0002] This application claims priority under 35 U.S.C. § 119(e) from U.S. Serial No. 62 / 782,943, filed December 20, 2018, and U.S. Serial No. 16 / 311,944, filed December 20, 2018, both in their entirety are considered to be part of the disclosure content of the present application and are incorporated by reference in its entirety into the disclosure content of the application. This application also incorporates by reference the disclosures of PCT Publication Nos. WO2017 / 223566 and WO2018 / 089709 as if incorporated herein in their entirety. technical field [0003] The present invention relates generally to pharmaceutical compositions, and more particularly to intranasal formulations comprising naltrexone and forms thereof, and methods of use thereof in the treatment of conditions such as opioid overdose and symptoms thereof and disorders such as alcohol use disorder, Intranasal formulations involving the administration of the o...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/357A61K31/4178A61K31/496A61K38/00A61M11/00
CPCA61M15/08A61M15/0098A61M11/007A61K31/485A61P1/00A61K47/26A61K9/0043A61K9/0019A61K9/20A61K47/183A61K47/186A61K9/00A61K31/357A61K31/4178A61K31/496A61K38/00A61M11/00A61K9/08A61K47/02A61P25/30A61P25/36A61P25/32
Inventor E·T·马乔R·克里斯特尔M·埃里森P·斯科尔尼克
Owner AEGIS THERAPEUTICS LLC
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