Cyclobenzaprine treatment for fibromyalgia

Transmucosal administration of cyclobenzaprine HCl in a eutectic form with a basicizing agent addresses the unmet need for fibromyalgia treatment, effectively reducing pain and improving sleep and fatigue through a multivariate dosing regimen.

JP2026113634APending Publication Date: 2026-07-07トニックス ファーマシューティカルズ ホールディング コーポレイション
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
トニックス ファーマシューティカルズ ホールディング コーポレイション
Filing Date
2026-04-03
Publication Date
2026-07-07

AI Technical Summary

Technical Problem

Current treatments for fibromyalgia, including FDA-approved drugs, provide incomplete relief for chronic pain, sleep disturbances, and fatigue, leading to substantial off-label use of narcotics and prescription sleep aids, with a significant unmet need for effective therapies.

Method used

Administering cyclobenzaprine HCl in a eutectic form comprising 75% ± 2% cyclobenzaprine HCl and 25% ± 2% mannitol, with a basicizing agent, via transmucosal routes such as sublingual, intraoral, or intranasal administration, in a multivariate dosing regimen of 2.8 mg daily for two weeks followed by 5.6 mg as necessary, to treat fibromyalgia symptoms.

Benefits of technology

Significantly reduces pain by over 30% and improves sleep quality and fatigue in fibromyalgia patients, offering a more effective alternative to existing treatments.

✦ Generated by Eureka AI based on patent content.

Smart Images

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Patent Text Reader

Abstract

The present invention provides a method for treating fibromyalgia and one or more of its associated symptoms, including pain, sleep disorders, and / or fatigue. [Solution] The method comprises the step of administering 5.6 mg of cyclobenzaprine HCl per day in one or more dose units by transmucosal administration to a subject requiring it, wherein the cyclobenzaprine HCl is in the form of a eutectic, and the one or more dose units further contain a basicizing agent.
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