Methods and compositions for treatment of pain using capsaicin
Inventors
Campbell, James N. • Hanson, Peter D. • Stevens, Randall
Assignees
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Publication Number
US-12201594-B2
Publication Date
2025-01-21
Expiration Date
Abstract
The invention provides methods and compositions for treatment of pain, such as joint pain, using capsaicin in a procedure that attenuates transient burning sensation experienced by patients due to capsaicin administration. The methods desirably provide relief from joint pain, such as osteoarthritic knee joint pain, for an extended duration, such as at least about 3 months, 6 months, 9 months, or 1 year. To attenuate the adverse side effect of a transient burning sensation caused by capsaicin-induced neuronal excitation, the methods utilize a cooling article, such as a material wrap cooled via a circulating fluid, to reduce the temperature of tissue to be exposed to capsaicin to within a certain range for certain durations of time, optionally in combination with administering a local anesthetic agent, resulting in the substantial reduction or even elimination of transient burning sensation caused by capsaicin.
Core Innovation
The invention relates to a method of ameliorating osteoarthritic joint pain in a human patient, including osteoarthritic joint pain in a knee joint. The method uses a cooling article applied to a human patient’s skin in proximity to the joint in need of pain relief therapy to achieve a temperature range of from 28°C to 30°C for tissue or fluid in the interior of the joint.
In the method, a local anesthetic agent may be administered into the joint, and a pharmaceutical composition comprising capsaicin is administered by injection into the joint. The method specifies delivering a capsaicin dose of 1 mg and flexing the joint 5 times, and optionally applying the cooling article before and after the capsaicin-related steps to thereby ameliorate joint pain.
The method limits pain-relief medicine to a single pain-relief local anesthetic agent selected from lidocaine and pharmaceutically acceptable salts thereof and capsaicin, and specifies that the capsaicin composition does not contain hyaluronic acid. The patent also describes an aqueous capsaicin injectable formulation including a solubilizing agent comprising a hydroxyalkanoic acid polyethylene glycolyl ester component together with polyethylene glycol, with additional components such as an antioxidant, a chelating agent, buffer components, and tonicity modifier components.
Claims Coverage
Two independent claims are identified. The covered inventive features center on cooling a knee-adjacent skin region to achieve a joint-interior temperature of 28°C to 30°C, injecting capsaicin to deliver 1 mg, flexing the joint 5 times, using a single local anesthetic agent selected from lidocaine with a specified dose range, and, in one claim variant, excluding hyaluronic acid from the capsaicin composition.
Cooling to an interior joint temperature range
Applying a cooling article to the patient’s skin in proximity to the joint to achieve a temperature in the range of from 28°C to 30°C for tissue or fluid in the interior of the joint.
Intra-joint capsaicin injection delivering 1 mg and joint flexing five times
Administering by injection into said joint a pharmaceutical composition comprising capsaicin in order to deliver a dose of capsaicin in an amount of 1 mg; and then the joint is flexed 5 times.
Single local anesthetic agent with specified dose range
Administering into said joint a pharmaceutical composition comprising a single pain-relief local anesthetic agent selected from the group consisting of lidocaine and a pharmaceutically acceptable salt thereof, in order to deliver a dose of lidocaine in an amount ranging from about 0.1 g to about 0.5 g; wherein the patient does not receive any pain-relief medicine other than the local anesthetic agent recited and capsaicin.
Capsaicin composition does not contain hyaluronic acid
The pharmaceutical composition comprising capsaicin does not contain hyaluronic acid.
Across the independent claims, the method of ameliorating osteoarthritic knee-joint pain is anchored by cooling to a specified interior joint temperature range, injecting capsaicin to deliver 1 mg followed by flexing the joint 5 times, and using a single lidocaine local anesthetic agent with a defined dose range; one claim further requires that the capsaicin composition does not contain hyaluronic acid.
Stated Advantages
Ameliorate joint pain in a human patient.
Amelioration of osteoarthritic joint pain in a human patient.
Documented Applications
Ameliorating osteoarthritic joint pain in a knee joint in a human patient.
Ameliorating pain associated with painful nerves such as intermetatarsal neuroma is described.
Intra-articular treatment of osteoarthritic knee joint pain using capsaicin injected into the knee joint with associated cooling and optional lidocaine.
Treatment of neuroma using trans-capsaicin with staged dosing and associated lidocaine local anesthesia and cooling, as described in the partial content summary.
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