A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of Etoreat®(Etodolac-Lidocaine Topical Patch) in the Treatment of Acute Low Back Pain

The purpose of this study is to evaluate efficacy, tolerability and safety of Etoreat®(Etodolac-Lidocaine Topical Patch) in the treatment of acute low back pain (LBP).

Start Date01 Nov 2013

Sponsor / Collaborator

Medrx Usa, Inc.

NCT01506154 / CompletedPhase 3

A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Topical Patch in the Treatment of Pain Due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of Shoulder

A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Pain due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of the Shoulder.

Start Date01 Dec 2011

Sponsor / Collaborator

Medrx Usa, Inc.

NCT01198834 / CompletedPhase 3

A Randomized, Multi-Center, Double-Blind, Factorial, Comparator and Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains

Start Date01 Sep 2010

Sponsor / Collaborator

Medrx Usa, Inc.

100 Clinical Results associated with Etodolac/Lidocaine

100 Translational Medicine associated with Etodolac/Lidocaine

100 Patents (Medical) associated with Etodolac/Lidocaine

Literatures (Medical) associated with Etodolac/Lidocaine

01 May 2016·European Journal of Pharmaceutics and BiopharmaceuticsQ2 · MEDICINE

Lidocaine self-sacrificially improves the skin permeation of the acidic and poorly water-soluble drug etodolac via its transformation into an ionic liquid

Q2 · MEDICINE

Article

Author: Hamamoto, Hidetoshi ; Ishida, Tatsuhiro ; Miwa, Yasushi

Poor transdermal penetration of active pharmaceutical ingredients (APIs) impairs both bioavailability and therapeutic benefits and is a major challenge in the development of transdermal drug delivery systems. Here, we transformed a poorly water-soluble drug, etodolac, into an ionic liquid in order to improve its hydrophobicity, hydrophilicity and skin permeability. The ionic liquid was prepared by mixing etodolac with lidocaine (1:1, mol/mol). Both the free drug and the transformed ionic liquid were characterized by differential scanning colorimetry (DSC), infrared spectroscopy (IR), and saturation concentration measurements. In addition, in vitro skin-permeation testing was carried out via an ionic liquid-containing patch (Etoreat patch). The lidocaine and etodolac in ionic liquid form led to a relatively lower melting point than either lidocaine or etodolac alone, and this improved the lipophilicity/hydrophilicity of etodolac. In vitro skin-permeation testing demonstrated that the Etoreat patch significantly increased the skin permeation of etodolac (9.3-fold) compared with an etodolac alone patch, although an Etoreat patch did not increase the skin permeation of lidocaine, which was consistent with the results when using a lidocaine alone patch. Lidocaine appeared to self-sacrificially improve the skin permeation of etodolac via its transformation into an ionic liquid. The data suggest that ionic liquids composed of approved drugs may substantially expand the formulation preparation method to meet the challenges of drugs which are characterized by poor rates of transdermal absorption.

100 Deals associated with Etodolac/Lidocaine

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute low back pain	Phase 3	US	Medrx Usa, Inc.	01 Nov 2013
Shoulder Pain	Phase 3	US	Medrx Usa, Inc.	01 Dec 2011
Ankle Injuries	Phase 3	US	Medrx Usa, Inc.	01 Sep 2010
Bursitis	Phase 3	US	Medrx Usa, Inc.	01 Jul 2010
Tendinopathy	Phase 3	US	Medrx Usa, Inc.	01 Jul 2010

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