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United States Patent (19) 11 Patent Number: 6,103,771 Galer Et Al

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United States Patent (19) 11 Patent Number: 6,103,771 Galer Et Al USOO61.03771A United States Patent (19) 11 Patent Number: 6,103,771 Galer et al. (45) Date of Patent: Aug. 15, 2000 54 METHOD OF TREATING NEUROMA PAIN Rowbotham et al., Pain, vol. 65, 1996, 39-44. 75 Inventors: Bradley S. Galer, Seattle, Wash.; Dini et al., Pain (Aug. 1993)54:223-6. (abstract only). Larry J. Caldwell, San Jose, Calif. Watson & Evans, Pain (Dec. 1992) 51:375–379, (abstract only). 73 Assignee: Caldwell Galer Incorporated, San Jose, Calif. Watson et al., Pain (Aug. 1989) 38:177-86. (abstract only). Alexander, Ian J. et al., “Morton's Neuroma: A Review of 21 Appl. No.: 09/045,285 Recent Concepts,” Orthopedics (Jan. 1987) vol. 10, No. 22 Filed: Mar 20, 1998 (1):103-106. Kittrelle, Jeffrey P. et al., “Cluster Headache Local Anes (51) Int. Cl." ..................................................... A61K 31/00 thetic Abortive Agents.” Arch Neurol (May 1985) vol. 52 U.S. Cl. .......................... 514/817; 514/818; 424/443; 42:496-498. 424/445; 424/446; 424/447; 424/449 Medicino, Samuel S. et al., “Morton's Neuroma update on 58 Field of Search ..................................... 424/443, 445, Diagnosis and Imaging,” Clinics In Podiatric Medicine and 424/446, 447, 449; 514/817, 818 Surgery (Apr. 1997) vol. 14, No. (2):303-311. 56) References Cited Nunan, Patrick J. et al., “Management of Morton's Neuroma U.S. PATENT DOCUMENTS In Athlete’s.” Clinics In Podiatric Medicine and Surgery (Jul 1997) vol. 14, No.(3):489–501. 4,440,777 4/1984 Zupan ..................................... 424/274 4,560.553 12/1985 Zupan ....................................... 424/78 Wu, Kent K., “Morton's Interdigital Neuroma: A Clinical 4,588,580 5/1986 Gale et al. ................................ 424/21 Review of Its Etiology, Treatment, and Results.” The Jour 4,911,707 3/1990 Heiber et al. ... ... 424/449 nal of Foot and Ankle Surgery (1996) vol. 35, No. 4,963,591 10/1990 Fourman et al. ... 514/944 (2):112–119. 5,069,909 12/1991 Sharma et al. ... ... 424/449 5,070,084 12/1991 Campbell ................................ 514/248 5,079,008 1/1992 Sinnreich et al. ...................... 424/448 Primary Examiner Dwayne C. Jones 5,330,452 7/1994 Zook .................... ... 604/307 ASSistant Examiner-C. Delacroix-Muirheid 5,368.860 11/1994 Sunami et al. ... 424/448 Attorney, Agent, or Firm-Bret Field; Bozicevic, Field & 5,401,728 3/1995 Simon ....................................... 514/78 Francis LLP 5,543,148 8/1996 Lapidus ................ ... 424/401 5,613,958 3/1997 Kochinke et al. ... ... 604/307 57 ABSTRACT 5,665,378 9/1997 Davis et al. ......... ... 424/448 5,667,719 9/1997 Caldwell et al. ....................... 424/449 Methods of treating a host Suffering from neuroma pain are provided. In the Subject methods, a topical local anesthetic FOREIGN PATENT DOCUMENTS composition is applied to a keratinized skin site of the host O 399 432 A2 11/1990 European Pat. Off.. proximal to the neuroma responsible for the neuroma pain. Preferably, the topical local anesthetic composition com OTHER PUBLICATIONS prises eucalyptol in addition to an effective amount of a local CAPLUS DN 115:105951, Rumsfield et al., DICP, Ann. anesthetic. The Subject methods find particular use in the Pharmacother., (1991), 25(4), 381-7, (abstract). treatment of pain associated with Morton's neuroma. Rumsfield et al., DICP. The Annals of Pharmacotherapy, vol. 25, Apr. 1991, 381-387. 13 Claims, No Drawings 6,103,771 1 2 METHOD OF TREATING NEUROMA PAIN variations of the particular embodiments may be made and Still fall within the Scope of the appended claims. It is also TECHNICAL FIELD to be understood that the terminology employed is for the purpose of describing particular embodiments, and is not The field of this invention is the treatment of neuroma intended to be limiting. Instead, the Scope of the present pain. invention will be established by the appended claims. BACKGROUND OF THE INVENTION In this Specification and the appended claims, the Singular forms “a,” “an,” and “the” include plural reference unless Neuromas, i.e. focal abnormal bundles of nerves under the context clearly dictates otherwise. Unless defined the skin, may result in presence of chronic pain. Neuromas otherwise, all technical and Scientific terms used herein have may result from repetitive blunt injury to a nerve, Such as in the same meaning as commonly understood to one of “Morton's Neuroma' which results due to chronic running ordinary skill in the art to which this invention belongs. or dancing, as well as following direct transection of a Topical compositions employed in the Subject method Sensory nerve, Such as those neuromas with amputation and will include a local anesthetic as the active agent. Although the Subsequent development of “neuroma Stump' pain. two or more local anesthetic agents may be present in the Current medical treatment options of neuroma pain are 15 Subject compositions, generally the Subject compositions limited. One method employed to treat neuroma pain will comprise a single local anesthetic agent. The local involves the direct injection of a steroid, with or without a anesthetic employed in the Subject methods will be an local anesthetic, into the neuroma to achieve an invasive anesthetic which, when administered in the topical nerve block. Such nerve blocks tend to provide only tran formulations, rapidly penetrates a keratinized Skin Surface to sitory relief. Furthermore, Such nerve blocks require physi reduce abnormal ectopic neuronal discharges in the neuro cian Visits, are invasive and can be painful. In addition, ma’s nerves underlying the skin Surface. The local anesthetic complications can arise from long term Steroid use associ will have a molecular weight and melting point that is ated with Such methods. Other treatment options include compatible with transport acroSS the keratinized Skin Sur Surgical transection and removal of the neuroma. While face. Generally, the molecular weight of the local anesthetic effective in removing the painful neuroma, new painful 25 will not exceed about 300 dal, and will more usually not neuromas frequently form at the Surgical site within a exceed about 250 dal. The melting point of the local relatively short time following Surgery. In addition, Surgery anesthetic will be less than about 100° C. In many is not always desirable because of its invasive nature, embodiments, the local anesthetic will be a compound potential for complications, and expense. Yet other treatment comprised of a Secondary or tertiary amine linked by a bond methodologies include the use of orthotic devices. However, or through a connecting group to an aromatic group. The Such devices rarely provide long-term pain relief. local anesthetic will generally be an alkanyl compound of Therefore, there is a continued need for the identification from about 9 to 20 carbon atoms. Because the composition of new methods for treating neuroma pain. Ideally, Such is applied topically, the local anesthetic will generally be methods should be simple enough to be Self-administered, present in the composition as a free base to promote pen be suitable for chronic use and afford effective relief from 35 etration of the agent through the skin Surface. A large neuroma pain. number of local anesthetics are known in the art, many of Relevant Literature which are Suitable for topical application. Suitable local References providing a review of neuromas and methods anesthetics include lidocaine, butamben, butanilicaine, ethyl for their treatment, particularly Morton's neuroma, include: aminobenzoate, fornocaine, hydroxyprocaine, isobutyl Nunan & Giesy, Clinics in Podiatric Medicine and Surgery p-aminobenzoate, naepaine, octacaine, parethoxycaine, 40 piridocaine, prilocaine, procaine, risocaine, tolycaine, (July 1997) 14: 489–501; Mendicino & Rockett, Clinics in trimecaine, particularly ethylaminobenzoate (benzocaine). Podiatric Medicine and Surgery (April 1997) 14: 303-311; The amount of local anesthetic present in the Subject com Wu, J. Foot Ankle Surg. (March 1996) 35: 112–119; and positions will be sufficient to provide an effective amount of Alexander et al., Orthopedics (January 1987) 10:103-106. the agent when topically administered according to the SUMMARY OF THE INVENTION 45 Subject methods. The precise amount of anesthetic agent present in the topical formulation will depend on the par Methods for treating a host Suffering from neuroma pain ticular agent employed, but will generally range from about are provided. In the Subject methods, a topical local anes 5 to 50% by weight, usually from about 10 to 40% by thetic composition is applied to a keratinized skin Site of a weight. host proximal to the underlying neuroma responsible for the 50 In preferred embodiments of the Subject invention, the neuroma pain. The composition preferably includes, in topical applications employed in the Subject methods con addition to an effective amount of a local anesthetic, euca tain eucalyptol, which Serves as a penetration enhancing lyptol. The Subject methods find particular application in the agent for the local anesthetic. Eucalyptol (1,3,3-trimethyl treatment of pain associated with Morton's neuroma. 2-oxabicyclo 2,2,2-octane) is the chief constituent of oil of DESCRIPTION OF THE SPECIFIC eucalyptus and is also known as cineole and cajeputol. 55 Eucalyptol is known in the art, having found use as an insect EMBODIMENTS repellant and as a flavoring agent. The amount of eucalyptol Methods are provided for at least reducing the pain present in the composition will range from about 10 to 80%, experienced by a host having a neuroma. In the Subject usually from about 10 to 50% by weight, and more usually methods, a topical local anesthetic composition comprising from about 20 to 40% by weight of the composition. an effective amount of a local anesthetic is applied to a 60 Optionally, the topical compositions employed in the keratinized skin Site of the host in a region proximal to the Subject methods may further comprise one or more addi neuroma.
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