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Treatment of length dependent neuropathy

A technology for neuropathy and dependence, applied in the direction of nervous system diseases, organic active ingredients, medical preparations containing active ingredients, etc., can solve problems such as limited pain relief, unstudied clonidine action site, etc.

Inactive Publication Date: 2015-12-16
ARCION THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although clonidine was statistically significant relative to placebo (p<0.015), clonidine often provided limited pain relief
The site of action of clonidine was not investigated in this study

Method used

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  • Treatment of length dependent neuropathy
  • Treatment of length dependent neuropathy
  • Treatment of length dependent neuropathy

Examples

Experimental program
Comparison scheme
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preparation example Construction

[0018]Although the above has been described with specific reference to compounds, enantiomers, stereoisomers, metabolites, derivatives and salts of the active compounds may also be used. Methods for the synthesis of these compounds are known to those skilled in the art. Examples of pharmaceutically acceptable salts include, but are not limited to: inorganic or organic acid salts of basic residues such as amines; alkali metal or organic salts of acidic residues such as carboxylic acids. Pharmaceutically acceptable salts include the conventional non-toxic or quaternary ammonium salts of the parent compound formed, for example, from non-toxic inorganic or organic acids. The conventional non-toxic salts mentioned above include those derived from inorganic acids such as hydrochloric, hydrobromic, sulfuric, sulfamic, phosphoric and nitric acids and those derived from organic acids such as acetic, propionic, succinic, glycolic, , stearic acid, lactic acid, malic acid, tartaric acid,...

Embodiment 1

[0034] Example 1: 0.1% Neuclon TM (Clonidine) topical gel formulation

[0035] 0.1% Neuclon TM (Clonidine) The topical gel contains 0.1 mg of clonidine hydrochloride per 1.0 g of gel. In order to maximize the amount of clonidine free base in the product, the pH of the gel was adjusted to 8.0. The pKa of clonidine hydrochloride is 8.2. The formulations are shown in Table 1.

[0036] Table 1. 0.1% Neuclon TM (Clonidine) topical gel formulation

[0037] Element

Embodiment 2

[0038] Example 2: Treatment of Patients with Diabetic Painful Neuropathy

[0039] The aim of this study was to test the analgesic effect of 0.1% and 0.2% topical clonidine gel relative to placebo gel in patients with diabetic chronic lower extremity painful neuropathy.

[0040] Materials and methods

[0041] One hundred and sixty-six (166) adult patients with diabetic chronic lower extremity painful neuropathy who met the study entry criteria were enrolled in this multicenter study. Diabetic patients with a clinical diagnosis of neuropathic pain had a mean daily pain score of 5 or higher using the 11-point Numeric Graphical Pain Scale (NGPS). Patients were allowed to continue taking other neuropathic pain medications as long as the doses of these medications were not changed 30 days before enrollment and during the study.

[0042] In this 10-week blinded parallel-design study, patients were randomized to either 0.1% or 0.2% topical clonidine gel or a placebo gel. Drug tre...

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Abstract

Compositions, and methods of use thereof, are provided for the treatment of painful neuropathy by local or topical delivery of compounds that interact with a-adrenergic receptors, especially an alpha2 adrenergic agonist such as clonidine, to the entire painful area such that the need for systemic dosing is minimized. The compounds are delivered to or adjacent to painful areas in patients with painful length dependent neuropathy, and other neuropathies that affect the pain signaling fibers in the skin. A preferred compound for the treatment of patients with length dependent neuropathy is clonidine applied in a transdermal patch, gel, ointment, lotion, liposomal formulation, cream, or emulsion, wherein the concentration is sufficient to provide an effective dose in the painful area or immediately adjacent areas.

Description

[0001] This application is a divisional application of a Chinese patent with an application date of November 7, 2006, an application number of 200680047961.1, and an invention title of "Treatment to Length-Dependent Neuropathy". technical field [0002] The present invention relates to the treatment of pain associated with length-dependent neuropathies and other neuropathies such as neuropathies that may arise from diabetes and other diseases. Background technique [0003] Pain is often produced by disorders affecting the somatosensory system. One disease that is often implicated is diabetes. Diabetes can affect the nervous system in different ways, but one typical condition is length-dependent neuropathy. Longer axons at this time preferentially exhibit neuropathy associated with degeneration and sensitization of nociceptors. The classic feature is burning pain, often involving the feet (since the axons leading to the feet represent the longest primary afferent fibers in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4168A61K45/00A61P25/02A61P25/04
CPCA61K31/40A61K31/41A61K31/4168A61K31/425A61K31/435A61K31/495A61K31/506A61K31/54A61P25/00A61P25/02A61P25/04
Inventor 詹姆斯·N·坎贝尔
Owner ARCION THERAPEUTICS