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Administration of capsaicinoids

a technology of capsaicin and capsaicin, which is applied in the direction of biocide, plant/algae/fungi/lichens, biocide composition, etc., can solve the problems of poor patient compliance, high dropout rate during clinical trials, and limited effectiveness of topically administered capsaicin in general. , to achieve the effect of reducing or eliminating such side effects, improving movement, and alleviating pain at the si

Inactive Publication Date: 2004-08-12
ALGORX PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0013] It is another object of the present invention to provide compositions and methods for relieving pain at an intra-articular site or at a body space by administering an injectable or implantable single dose of capsaicin or capsaicin analogue to the intra-articular site or body space.
[0229] In certain embodiments, a vasodilator and a vasoconstrictor can be used as adjunctive therapy for capsaicinoid administration. For example, the capsaicinoid can be administered with a vasodilator at the intended site. To compliment the capsaicinoid therapy, a local anesthetic can be administered at a distal site to provide a regional block at the site of capsaicinoid administration. The vasoconstrictor can be administered with the local anesthetic to prolong the duration of effect of the local anesthetic.

Problems solved by technology

However the efficacy of topically administered capsaicin in arthritis in general has proven to be limited.
However, since the application of capsaicin itself frequently causes burning pain and hyperalgesia apart from the neuropathic pain being treated, patient compliance has been poor and the drop out rates during clinical trials have exceeded fifty percent.

Method used

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  • Administration of capsaicinoids
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Examples

Experimental program
Comparison scheme
Effect test

example ii

Osteoarthritis of the Knee Efficacy Study

[0252] The following clinical study evaluates the efficacy of purified capsaicin administered by intra-articular infiltration together with a local anesthetic injected by intra-articular infiltration in subjects with osteoarthritis of the knee.

[0253] The primary objective of the study is to evaluate the efficacy of intra-articular capsaicin, when co-administered with intra-articular local anesthetic, compared to placebo, in subjects with end-stage osteoarthritis of the knee, already scheduled to receive knee replacements (21 and 42 days after injection of study medication).

[0254] Purified capsaicin is supplied in vials containing 5 mL of purified capsaicin at a concentrations of 500 .mu.g / mL. Study drug was stored at a temperature between 15.degree. C. and 25.degree. C. Within four hours prior to injection, vehicle is used to dilute the drug to final concentrations of purified capsaicin, as follows:

15TABLE 2 Dose Level Concentration Total Vol...

example iii

Bunionectomy Efficacy Study

[0261] The following study was carried out in order to evaluate the safety, tolerability, systemic pharmacokinetics, and efficacy of intra-operative (infiltration) capsaicin when co-administered with a local anesthetic in patients scheduled to undergo transpositional osteotomy (bunionectomy).

[0262] The primary objective of the study was to evaluate the safety and tolerability of capsaicin, when co-administered by intra-articular infiltration with a local anesthetic, compared to placebo, in subjects with hallux valgus deformity, already scheduled to undergo transpositional osteotomy (bunionectomy). The secondary objective of the study was to evaluate the safety, tolerability and systemic pharmacokinetics of purified capsaicin following intra-operative administration. The primary efficacy endpoint was the proportion of subjects in each treatment group requiring opioid analgesia in the first 24 hours post-operatively. The proportions were compared amongst tre...

example iv

Median Sternotomy Study

[0277] The primary objective of the study is to determine the amount of opioid consumption and postoperative pain scores following median stemotomy for patients receiving purified capsaicin by infiltration and / or injection. Eligible subjects are patients undergoing cardiac, pulmonary, or mediastinal surgery for any indication between the ages of 20-70 years. The operation is performed under general anesthesia and are closely observed in a post-anesthesia care unit as per the practice of the institution. The study drug will be administered to the sternal edges, muscles (e.g., muscle edges), bone (e.g., bone edges), and tissues. All patients receive standard of care opioid on demand for treatment of pain when transferred to the ward. The dose of capsaicin is administered to the sternal edges, the muscle, the tissues and / or bone.

[0278] Pain is assessed utilizing VAS 100 mm scale--baseline, every 60 minutes beginning when the patient first is placed in a bedside c...

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Abstract

Disclosed in certain embodiments is a method for relieving pain at a site in a human or animal in need thereof, comprising administering by injection or infiltration, a dose of a capsaicinoid and coadministering a vasodilator.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 60 / 434,453, filed Dec. 18, 2002, U.S. Provisional Patent Application No. 60 / 434,530, filed Dec. 18, 2002, U.S. Provisional Patent Application No. 60 / 434,500, filed Dec. 18, 2002, U.S. Provisional Patent Application No. 60 / 434,828, filed Dec. 18, 2002, U.S. Provisional Patent Application No. 60 / 434,452, filed Dec. 18, 2002, U.S. Provisional Patent Application No. 60 / 434,501, filed Dec. 18, 2002, and U.S. Provisional Patent Application No. 60 / 461,164, filed Apr. 8, 2003, the disclosures of which is hereby incorporated by reference in their entirety.[0002] This application is directed to compositions and methods for relieving pain at a specific site, for example, associated with inflammation of joints, tendons, nerves, muscle, and other soft tissues, nerve injury and neuropathies, and pain from tumors in soft tissues or bone.[0003] Capsaicin, a pungent substance derived from the plants of the solanace...

Claims

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Application Information

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IPC IPC(8): A61K31/05A61K31/16A61K31/165A61K31/5415A61K31/551A61K36/81A61K45/06C07C231/02C07C233/20
CPCA61K31/05A61K31/16A61K31/165A61K31/5415A61K31/551A61K31/167A61K45/06C07C231/02A61K36/81A61K2300/00C07C233/20A61P25/00A61P25/02A61P29/00A61P43/00
Inventor BURCH, RONALD M.CARTER, RICHARD B.LAZAR, JEFF
Owner ALGORX PHARMA INC
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