Infiltration of capsaicin into surgical sites and open wounds

Inactive Publication Date: 2005-01-27
ALGORX PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0026] In certain preferred embodiments, the capsaicinoid administration provides an effect selected from the group consisting of: a) producing a selective, highly-localized destruction or incapacitation of C-fibers and / or A-delta fibers in a localized area responsible for the initiation of pain for the purpose of reducing or eliminating pain arising from the area, and b) minimizing potential adverse consequences of C-fiber and / or A-delta activation and or damage outside of the locus of 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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  • Infiltration of capsaicin into surgical sites and open wounds
  • Infiltration of capsaicin into surgical sites and open wounds
  • Infiltration of capsaicin into surgical sites and open wounds

Examples

Experimental program
Comparison scheme
Effect test

example i

Osteoarthritis of the Knee Safety study

[0137] 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.

[0138] 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.

[0139] Purified capsaicin was supplied in vials containing 5mL 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 1Dos...

example ii

Osteoarthritis of the Knee Efficacy Study

[0156] The following clinical study evaluated 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.

[0157] The primary objective of the study was 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).

[0158] Purified capsaicin was supplied in vials containing 5mL 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 2Dose LevelConcentrationTotal Volume of Dose1000...

example iii

Bunionectomy Efficacy Study

[0165] 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).

[0166] 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 t...

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Abstract

The present invention provides compositions and methods for attenuating or relieving pain at a site in a human or animal in need thereof by infiltrating at a surgical site or open wound in a human or animal a dose of capsaicinoid in an amount effective to denervate the surgical site or open wound substantially without eliciting an effect outside the surgical site or open wound.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 60 / 434,453, 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 substance derived from the plants of the solanaceae family (hot chili peppers) has long been used as an experimental tool because of its selective action on the small diameter afferent nerve fibers C-fibers and A-delta fibers that are believed to signal pain. From studies in animals, capsaicin appears to trigger C-fiber membrane depolarization by opening catio...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/05A61K31/16A61K31/165A61K31/5415A61K31/551A61K36/81A61K45/06A61K47/10C07C231/02C07C233/20
CPCA61K9/0019A61K31/05A61K31/16A61K31/165A61K31/5415A61K31/551A61K36/81A61K45/06A61K47/10C07C231/02A61K2300/00C07C233/20A61P19/02A61P23/00A61P23/02A61P25/00A61P25/02A61P25/04A61P29/00A61P29/02A61P43/00
Inventor BURCH, RONALD M.CARTER, RICHARD B.LAZAR, JEFF
Owner ALGORX PHARMA INC
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