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(12) Patent Application Publication (10) Pub. No.: US 2007/0065463 A1 Aung-Din (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2007/0065463 A1 Aung-Din (43) Pub US 20070065463A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2007/0065463 A1 Aung-Din (43) Pub. Date: Mar. 22, 2007 (54) TOPICAL THERAPY FOR THE TREATMENT Publication Classification OF MIGRANES, MUSCLE SPRAINS, MUSCLE SPASMS, SPASTICITY AND (51) Int. Cl. RELATED CONDITIONS A6IR 39/08 (2006.01) A6II 3/55 (2006.01) (76) Inventor: Ronald Aung-Din, Sarasota, FL (US) A6II 3L/48 (2006.01) Correspondence Address: A6II 3L/498 (2006.01) DAVIDSON, DAVIDSON & KAPPEL, LLC A6II 3/445 (2006.01) 485 SEVENTH AVENUE, 14TH FLOOR (52) U.S. Cl. ...................... 424/239.1: 514/288: 514/419; NEW YORK, NY 10018 (US) 514/250; 514/221; 514/305; 514/317; 514/718 (21) Appl. No.: 10/560,889 (22) PCT Filed: Jun. 21, 2004 (57) ABSTRACT (86). PCT No.: PCT/USO4/19816 The invention is directed to topical formulations and meth S 371(c)(1), ods of treating a migraines and/or cluster headaches, muscle (2), (4) Date: May 15, 2006 sprains, muscle spasms, spasticity, tension headaches, ten Related U.S. Application Data sion related migraines and related conditions associated with muscle tension and pain with a therapeutically effective (60) Provisional application No. 60/480,089, filed on Jun. amount of an ergot alkaloid, skeletal muscle relaxant, sero 20, 2003. Provisional application No. 60/480,088, tonin agonist, combinations thereof, pharmaceutically filed on Jun. 20, 2003. Provisional application No. acceptable salt thereof, prodrugs thereof or derivative 60/513,082, filed on Oct. 21, 2003. thereof. US 2007/0065463 A1 Mar. 22, 2007 TOPCAL THERAPY FOR THE TREATMENT OF and spinal cord injury. Tension headaches and tension MIGRANES, MUSCLE SPRAINS, MUSCLE related migraines are a result of over activity of muscles of SPASMS, SPASTICITY AND RELATED the scalp, forehead and neck. CONDITIONS 0006 Ergot is the product of a fungus that grows most predominantly on rye with other grains being affected. Since BACKGROUND OF THE INVENTION the discovery of ergot and ergot alkaloids over four hundred 0001. The present invention is directed to methods and years ago, the cumulative results of many diverse studies formulations for treating migraines, muscle sprains, muscle have indicated that ergot alkaloids play a significant role in spasms, spasticity, tension headache, tension-related the functioning of the mammalian body. For example, the migraines and related conditions associated with muscle pharmacological effects of ergot alkaloids on the uterus, tension and pain. cardiovascular system, Smooth muscles and vasculature have been studied. 0002 Migraine headaches are a debilitating condition in which Some 53 million persons per year Suffer acute pain. 0007 Ergot alkaloids pharmacological actions are com Frequently, migraine is accompanied by sickness and Vom plex due to their effects on several different receptors. iting and a sensitivity to light and noise. However, clinical applications for ergot alkaloids have been studied in various disease states and medical conditions, 0003. Several theories on the pathogenesis of migraine e.g., Parkinson's disease and postpartum hemorrhage. One have been hypothesized and include: i) the vascular theory particular area where the therapeutic use of ergot alkaloids (i.e., migraine is a vasospastic disorder that is initiated by has received particular attention is in the treatment of vasoconstriction in the cranial vasculature); ii) the cortical migraines. spreading depression theory (i.e., CSD begins with a brief wave of excitation, followed by a prolonged period of 0008 Ergot alkaloids have been used for treating neuronal depression, which is associated with disturbances migraines since the 1920s and their continued use for the in nerve cell metabolism and regional reductions in blood acute relief of moderate or severe migraine is still being flow); iii) the neurovascular hypothesis (i.e., migraine trig studied today. The ergot alkaloids possess varied and com gers or CSD can activate trigeminal nerve axons, which then plex pharmacological actions due to there ability to act as release neuropeptides, such as Substance P. neurokinin A, partial agonists or antagonists at 5HT and 5HT receptors as and CGRP) from axon terminals near the meningeal and well as adrenergic, dopaminergic and tryptaminergic recep other blood vessels that produce an inflammatory response tors. The spectrum of their effects depends upon the agent(s), in the area around the innervated blood vessels); iv) the dosage, species, tissue, and experimental or physiological serotonergic abnormalities hypothesis (i.e., proposes that conditions. It is because of the ergot alkaloids multiple serotonin may be involved in the pathogenesis of migraine pharmacological effects on the various receptors that their due to observations that both plasma and platelet levels of exact mechanism of action for treating migraine is uncertain. serotonin fluctuate during a migraine attack, an initial Surge 0009. In the prior art, ergot alkaloids have been used for in plasma serotonin levels may cause constriction of cerebral the local treatment of various disease states and conditions. blood vessels and a reduction in cerebral blood flow. If the 0010 For example, U.S. Pat. No. 4,916,132 to Seibel blood flow is sufficiently reduced, migraine aura may result); describes dihydroergotamine compositions and methods of and V) the integrated hypothesis (i.e., triggers such as stress, preparing the same for use in the local treatment of trophic glare, noise, the patients internal clock, the dilation of the disturbances, e.g., Stasis dermatoses, ulcers and tissue death. internal or external carotid arteries, or other factors may activate specific centers in the brain stem causing migraine). 0.011) Additionally, U.S. Published Patent Application No. 2002/0042438 to Pelletier et al. describes a method of 0004 Muscle sprains, muscle spasms, spasticity, tension reducing or inhibiting the glycation of skin proteins, in headaches and tension-related migraines are also common particular, for preventing or treating the signs of ageing of debilitating conditions that are associated with acute pain, the skin and/or the orange-peel appearance of the skin and chronic pain and involuntary movement that can be so for slimming and/or refining the silhouette and contours of severe that the condition(s) frequently disrupt an individu the face, by topically applying a composition containing an als daily life. ergothioneine or derivative thereof to the skin of a person. 0005 Muscle spasm may occur as a result of direct soft 0012. As with the ergot alkaloids, many diverse studies tissue trauma with spasm of injured muscles. It may also utilizing serotonin (5 hydroxytryptamine, 5-HT) have indi arise as a consequence of spinal nerve root irritation from cated that serotonin plays a significant role in the function musculo-skeletal injury. Para spinal muscles are primarily ing of the mammalian body, both in the central nervous affected in this situation, so called “cervical and lumbar system and in peripheral systems as well. Morphological sprains.” Muscle spasm can manifest as a Sudden involun studies of the central nervous system have shown that tary contraction of one or more muscle groups and is usually serotonergic neurons, which originate in the brain stem, an acute condition associated with muscle strain (partial tear form a very diffuse system that projects to most areas of the of a muscle) or sprain (partial or complete rupture of a brain and spinal cord. R. A. O’Brien, Serotonin in Mental ligament). Spasticity is a state of increased muscular tone Abnormalities, 1: 41 (1978); H. W. M. Steinbusch, HAND with exaggeration of the tendon reflexes from an upper BOOK OF CHEMICAL NEUROANATOMY, Volume 3, motor neuron (brain or spinal cord) injury in which spinal Part II, 68 (1984); N. E. Anden, et al., Acta Physiological inhibitory processes are suppressed or lost. The result is Scandinavia, 67: 313 (1966). These studies have been chronic, severe spasm of the muscles of the extremities complemented by biochemical evidence that indicates large hindering function and causing pain. Spasticity is often concentrations of 5-HT exist in the brain and spinal cord. H. associated with illnesses such as multiple Sclerosis, stroke W. M. Steinbusch, supra. US 2007/0065463 A1 Mar. 22, 2007 0013 Serotonin (5-hydroxytryptamine, 5-HT) is said to The drawback of the oral or parenteral administration is that play a key role in regulating the vascular tone, and serotonin there are frequent systemic side effects such as fatigue, deficiency is said to result in a vasodilatation causing the lethargy, weakness and mental clouding, particularly as migrainous headache. The onset of action is affected via higher doses are reached. BenZodiazepines, e.g., diazepam, 5-HT-receptors in the region of the vascular walls of have additional drawbacks such as tolerance, psychological cerebral arteries. dependency and withdrawal effects, e.g., seizures. Oral 0014. Accordingly, in the last few years, the chemical administration route also entails delay of drug effect through structure of serotonin has been modified in various manners, gastrointestinal absorption and systemic circulation. resulting in changes of the pharmacological properties. For 0021. In certain instances skeletal muscle relaxants can example, indole derivatives were synthesized which cause also be administered topically. For example, U.S. Pat. No. the cerebral vessels to be selectively tonizised (contracted) 5,364,628 to Kissel et al. describes a transdermal adhesive combined with a rapid improvement of the symptoms. These plaster or patch containing tizanidine for application every are so-called serotonin agonists having a particular affinity three days for the systemic treatment of rheumatic pains and for 5-HT-receptors. muscle spasms. Also, UK Patent Application No. 2098865 0.015 The class of serotonin agonists having a particular to Joachim Franz et al. describes a composition and method affinity for 5-HT, receptors are typified, for example, by for administering a Sustained release micro emulsion con Sumatriptan, Zolmitriptan, naratriptan, and rizatriptan to taining tizanidine. A suitable dose of 10-50 mg of tizanidine name a few.
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