Topical composition for treating pain

Abstract

Topical compositions having as the active ingredient a lipid, fatty acid ester, natural wax, sterol, or combinations thereof referred to herein as “lipophilic vehicle” or “LV” and methods of use, have been developed for the amelioration or prevention of pain or the sequelae of pain. The composition may be in the form of an ointment, cream, gel, lotion, spray, foam, paste, patch, suspension or dispersion. In the preferred embodiment, the formulation is a gel. The LV may contain a penetration enhancer, most preferably one with membrane disruptive properties. The formulation may be applied to or impregnated into a gauze, wrap, bandage, cotton-tipped stick, adhesive bandage strip, or other support wrap or medical bandage or wound cover. For example, the compositions may be are incorporated onto or into disposables such as hemorrhoid wipes, sponge, mouth guards, dental trays; needles or catheters; adult diapers; gloves, socks or wrist bands, for ease of application. The composition is applied topically to a site at or adjacent to a painful region. The composition is reapplied as necessary. Pain relief is typically obtained within minutes and lasts for periods of variable duration ranging from minutes to several hours and even, in some cases, days. The composition is variably effective to treat visceral, somatic and neuropathic pain both acute and chronic as well as muscle pain and stiffness and joint pain and stiffness.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. application Ser. No. 11 / 851,241, filed Sep. 6, 2007, which claims the benefit of U.S. Provisional Application Ser. No. 60 / 943,552, filed Jun. 12, 2007, each of which is hereby incorporated by reference in its entirety.FIELD OF THE INVENTION[0002]The present invention relates to a topical treatment of acute and chronic pain, which is somatic, visceral, or neuropathic, as well as joint and muscle stiffness. This treatment also addresses to some degree the psychologic, vegetative and medication-induced sequelae of pain (usually chronic) which can include fatigue, decreased alertness, weight gain, decreased exercise tolerance, and dyspnea.BACKGROUND OF THE INVENTION[0003]Pain is a sensation and a perception that is comprised of a complex series of mechanisms. In its most simple construction, it is a signal from the firing of nociception, touch and pressure receptors in the periphery that is transmitt...

AI Technical Summary

Benefits of technology

[0013]The composition is applied topically to a site at or adjacent to a painful region. The composition is reapplied as necessary. Pain relief is typically obtained within minutes and lasts for periods of variable duration ranging from minutes to several hours and even, in some cases, days. The compounds are applied such that the dosage is sufficient to provide an effective dose in the painful area or immediately adjacent areas, to ameliorate or eliminate pain. The composition is variably effective to treat visceral, somatic, inflammatory and neuropathic pain both acute and chronic as well as muscle pain and stiffness and joint pain and stiffness. Examples demonstrate pain relief in human patients for a wide number of conditions, including joint, muscle and tendon pain, joint, muscle and tendon immobility, inflammatory pain, neuropathies, muscle spasms, osteoarthritis, breathing disorders such as wheezing, hunger pains, some types of headaches, dysphagia, fibromyalgia, autoimmune disorders, dysmennorhea, post-surgical pain, anal fissures and visceral pain resulting from chronic and pancreatitis.

Problems solved by technology

In addition, the psychologic component of chronic pain can lead to fatigue, weight gain, increased appetite, decreased concentration and awareness, decreased energy, and psychomotor retardation which often require further adjunctive therapy such as antidepressants and stimulants.

Associated comorbid conditions such as COPD, asthma, and hypertension can lead to dyspnea and decreased exercise tolerance, thereby exacerbating the downward spiral and depression which often characterizes chronic pain syndromes and necessitates further adjunctive treatment.

Moreover, most topical treatments to control pain are of limited efficacy or last only for a few minutes, such as the lidocaine sprays and patches and benzocaine ointments.

Pain of all types can be debilitating both psychologically and physically and exacts an enormous toll in dollars, decreased productivity, and quality of life.