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Injectable capsaicin

a technology of capsaicin and injection, which is applied in the field of pain relief, can solve the problems of poor patient compliance, high dropout rate during clinical trials, and limited effectiveness of topically administered capsaicin in general arthritis, and achieves the effects of reducing or eliminating pain, and minimizing the potential adverse effects of c-fiber

Inactive Publication Date: 2008-10-23
SOFINNOVA VENTURE PARTNERS VII
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This approach provides effective, localized pain relief for acute or chronic pain, neuropathic pain, and orthopedic disorders, with reduced adverse effects and prolonged pain attenuation for up to 16 weeks, maintaining sensation while minimizing breakthrough pain.

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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  • Injectable capsaicin

Examples

Experimental program
Comparison scheme
Effect test

example i

Osteoarthritis of the Knee Safety Study

[0130]The following clinical study was carried out in order to evaluate the safety, tolerability, systemic pharmacokinetics, and efficacy of purified capsaicin administered by intra-articular infiltration together with a local anesthetic administered by intra-articular infiltration in subjects with osteoarthritis of the knee.

[0131]The primary objective of the study was to evaluate the safety and tolerability 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.

[0132]Purified capsaicin was supplied in vials containing 5 mL of purified capsaicin at a concentrations of 500 μg / mL. Study drug was stored at a temperature between 15° C. and 25° C. Within four hours prior to injection, vehicle was used to dilute the drug to final concentrations of purified capsaicin, as follows:

TABLE 1Dose Level...

example ii

Osteoarthritis of the Knee Efficacy Study

[0149]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.

[0150]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).

[0151]Purified capsaicin is supplied in vials containing 5 mL of purified capsaicin at a concentrations of 500 μg / mL. Study drug was stored at a temperature between 15° C. and 25° C. Within four hours prior to injection, vehicle is used to dilute the drug to final concentrations of purified capsaicin, as follows:

TABLE 2Dose LevelConcentrationTotal Volume of Dose1000 μg200 μg / ...

example iii

Bunionectomy Efficacy Study

[0158]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).

[0159]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 treat...

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PUM

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Abstract

The present invention provides compositions and methods for relieving pain at a site in a human or animal in need thereof by administering at a discrete site in a human or animal in need thereof a dose of capsaicin in an amount effective to denervate a discrete site without eliciting an effect outside the discrete location, the dose of capsaicin ranging from 1 μg to 3000 μg.

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.FIELD OF THE INVENTION[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.BACKGROUND OF THE INVENTION[0003]Capsaicin, a pungent sub...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K36/81A61K31/165A61K9/00A61P29/00A61K31/05A61K31/16A61K31/5415A61K31/551A61K45/06A61K47/10C07C231/02C07C233/20
CPCA61K9/0019A61K31/05A61K31/16A61K31/165A61K31/5415A61K31/551A61K36/81A61K45/06A61K47/10C07C231/02A61K2300/00C07C233/20A61P19/02A61P23/00A61P23/02A61P25/00A61P25/02A61P25/04A61P29/00A61P29/02A61P43/00
Inventor BURCH, RONALDCARTER, RICHARD B.LAZAR, JEFF
Owner SOFINNOVA VENTURE PARTNERS VII
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