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(12) Patent Application Publication (10) Pub. No.: US 2003/0104085A1 Yeomans (43) Pub US 20030104085A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2003/0104085A1 Yeomans (43) Pub. Date: Jun. 5, 2003 (54) METHODS AND COMPOSITIONS FOR (22) Filed: Dec. 5, 2001 TREATING BACK PAIN Publication Classification (76) Inventor: David C. Yeomans, Los Altos, CA (US) (51) Int. Cl." ......................... A61K 31/24; A61K 35/78; A61K 31/16 Correspondence Address: (52) U.S. Cl. ........................... 424/760; 514/537; 514/625 TOWNSEND AND TOWNSEND AND CREW, LLP (57) ABSTRACT TWO EMBARCADERO CENTER EIGHTH FLOOR The present invention provides methods and kits for treating SAN FRANCISCO, CA 94111-3834 (US) back pain, especially chronic back pain. The methods com prise administering a Vanilloid receptor agonist, preferably a (21) Appl. No.: 10/006,858 capsaicin. US 2003/0104085A1 Jun. 5, 2003 METHODS AND COMPOSITIONS FOR TREATING 0005 Under normal conditions, nerve fibers sparsely BACK PAIN innervate the Surface of discs. After disc injury Such as by herniation or a tear, nerve fibers grow from the Surface in BACKGROUND OF THE INVENTION toward the center. There is also an increase in the number of 0001 Current analgesic therapies often fall short of thera nerve branches that innervate the disc. These nerve branches peutic goals and typically have unacceptable Side effects. In show distinct Signs of being of the type that carry pain many chronic pain Syndromes, Such as those Subsequent to messages, and it is thought that they provide the underlying neuropathic injury, pain is not well controlled by any cur pathology of So-called “discogenic pain.” These endings rently available method. The Sensation of pain is transduced express the neuropeptide Substance P. Substance P is typi in the periphery by pain-Sensing, i.e. nociceptive, C- and cally identified with pain transducing neurons and neurons A-delta primary afferent neurons. These neurons have a that contain Substance P typically express VR1 receptors. peripheral nerve ending in the skin or deep tissues and a Palmgren et al., Spine 21(11): 1301-1306 (1996); Palmgren central terminal that makes Synaptic contact with Second et al., Spine 24(20):2075 (1999); Freemont et al., The Lancet order neurons in the Spinal cord dorsal horn. The impulse is 350:178-181 (1997). One characteristic of many pain neu processed locally for activation of withdrawal reflexes and rons is that they are Sensitive to capsaicin and Similar relayed to the brain for conscious perception and contextu Vanilloids. Lower concentrations can cause pain followed by ally relevant integrated responses. deSensitization. Higher concentrations cause pain, followed 0002 Vanilloid receptor-1 (VR1) is a multimeric cation by “killing back” of the nerve fibers toward their cells of channel prominently expressed in nociceptive primary affer origin in the dorsal root ganglia. ent neurons (see, e.g., Caterina et al., Nature 389:8160824, 0006 Treatments for other types of pain, particularly of 1997; Tominaga et al., Neuron 531-543, 1998). Activation of cutaneous origin, have been developed using capsaicin. the receptor typically occurs at the nerve endings via appli Some of these, with relatively low concentrations, are avail cation of painful heat (VR1 transduces heat pain) or during able over the counter as creams and would usually be used inflammation or exposure to vanilloids. Activation of VR1 in conjunction with local anesthetics, as capsaicin can be by an agonist, Such as resiniferatoxin or capsaicin, results in quite painful. the opening of calcium channels and the transduction of pain sensation (see, e.g., Szallasi et al., Mol. Pharmacol. 56:581 SUMMARY OF THE INVENTION 587, 1999.) After an initial activation of VR1, VR1 agonists desensitize VR1 to Subsequent stimuli. This desensitization 0007. The present invention features methods for treating phenomenon has been exploited in order to produce anal discogenic pain by injecting a Vanilloid agonist or a formu gesia to Subsequent nociceptive challenge. For example, it lation comprising a vanilloid agonist into the intravertebral has been shown that topical administration of resinferatoxin Space of patients having discogenic pain. The Vanilloid (RTX), which is a potent Vanilloid receptor agonist, at the agonist functions by killing back the aberrant nerve fibers, nerve endings in the skin triggerS along-lasting insensitivity eliminating the Source of pain. Based on results in other to chemical pain Stimulation. Furthermore, it has been tissues, Such an approach should lead to pain relief for many shown that both Subcutaneous and epidural administration of months, if not permanently. In Some embodiments, a Vanil the RTX produce thermal analgesia when administered to loid agonist may be administered on multiple occassions. rats, with no restoration of pain Sensitivity for over 7 days 0008 Specifically, the present invention is applicable to (see, e.g., Szabo et al., Brain Res. 840:92-98, 1999). pain that involves activation of Vanilloid receptor-bearing 0003. The effects of intrathecal capsaicin on thermal neurons. In particular, Selective deletion of nociceptive Sensitivity in rats have been investigated. The results, how primary afferent neurons by administration of a Vanilloid ever, have been conflicting (Nagy et al., Brain Res. 211:497 agonist, e.g., capsaicin or resiniferatoxin (RTX) interrupts 502, 1981; Palermo et al., Brain Res. 208:506-510; Yaksh et the Signaling pathway and blocks pain Sensation and neu al., Science 206:481-483, 1979; and Russell et al., Pain rogenic inflammation. This Selective application can be used 25:109-123, 1986). Russell et al. observed no thermal anal for treatment-resistant back pain. Thus, the invention pro gesia, although in three previous Studies, at least Some vides a method of treating pain by ablating pain-Sensing degree of thermal analgesia was observed. The conflicting CUOS. results raised a number of issueS Such as the possibility of 0009. In some embodiments, the vanilloid receptor 1 complications in data interpretation resulting from Spinal agonist is administered to a patient Suffering from chronic cord damage from cannula implantation, or Solvent toxicity pain. Preferably, the Vanilloid receptor agonist is Selected problems. from the group consisting of a resiniferatoxin or a capsaicin, 0004 Low back pain exerts an enormous sociological Such as OVanil. In especially preferred embodiments, the and economic cost upon the nation. Currently treatments for VR1 agonist is capsaicin. In Some embodiments, adminis intractable cases are frequently unsuccessful as well as tration comprises direct injection into the intravertebral disc. extremely expensive. These generally involve Surgical In preferred embodiments, the amount of Vanilloid agonist removal of intervertebral disc material, which is thought to administered is Sufficient to ablate the neurons. In Some be the Source of pain in many cases. Other treatments have embodiments this may be from 50 nanograms to 50 micro included inserting a wire into the disc which is then heated grams. Often the amount is from about 500 nanograms to to shrink the disc, and injection of enzyme Solutions (par about 50 micrograms. In Some embodiments, the method ticularly papain) into the disc to dissolve it. The former is further comprises administering a local anesthetic, often fairly popular, although there are no well controlled Studies lidocaine or bupivacaine. that demonstrate efficacy, and the later has been abandoned 0010. In another aspect, the invention provides a kit for due to allergic responses. treating back pain, Said kit comprising a compartment con US 2003/0104085A1 Jun. 5, 2003 taining a Vanilloid receptor agonist in an amount Sufficient to Means to diagnosis chronic pain include classical clinical ablate the neurons and instructional materials describing and psychological evaluations, which can be augmented by how to use the kit. Such a kit can also contain a local various laboratory procedures, as described herein. Such anesthetic. In particular embodiments, the Vanilloid receptor means are well described in the medical, Scientific and agonist is a capsaicin. patent literature. 0021 One criteria to diagnose a “chronic' pain is DETAILED DESCRIPTION whether the pain persists for a month beyond the usual 0.011 This invention pertains to the surprising discovery course of an acute disease or a reasonable time for an injury that administration of Vanilloid receptor agonist Such as a to heal. This evaluation is made by the clinician on a case by resinaferatoxin or a capsaicin directly into the intravertebral case basis. Acute diseases or injuries can heal in 2, 3, or, at Space is useful to Selectively treat acute and chronic pain. most, 6 weeks, depending on the nature of the condition or The method is useful for the treatment of chronic pain, injury, the age and health of the patient, and the like. For particularly including, but not limited, to back pain. example, a simple wrist fracture can remain painful for a week to ten days; however, if pain persists longer than this 0012. The term “VR1 agonist” as used herein refers to a period, a dystropathy could be developing which will be to a compound that binds to VR1 and stimulates calcium irreversible if not treated. See, e.g., Bonica, et al., (1990) uptake. Typically, VR1 agonists comprise a Vanilloid ring “Management of Pain, 2nd Ed., Vol. 1, Lea & Feibiger, that is important for agonist activity. Phil., Pa.; Wall and Melzack (1994) “Textbook of Pain.” 0013 The term “discogenic pain” refers to
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