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(12) United States Patent (10) Patent No.: US 6,462,084 B1 Dewevy Et Al

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(12) United States Patent (10) Patent No.: US 6,462,084 B1 Dewevy Et Al USOO6462084B1 (12) United States Patent (10) Patent No.: US 6,462,084 B1 Dewevy et al. 45) Date of Patent: Oct. 8,9 2002 (54) TREATMENT FOR OBSESSIVE- 4,786.647 A 11/1988 Simplins et al. COMPULSIVE DISORDER (OCD) AND OCD- 4,980,168 A 12/1990 Sahley RELATED DISORDERS USING GVG 5,189,064 A 2/1993 Blum et al. 5,776.956 A 7/1998 Rolf 5,792,796 A * 8/1998 Woodruffet al. ........... 514/561 (75) Inventors: Stephen L. Dewey, Manorville, NY 6,117,855. A 9/2000 Carlson et al. ............... 514/90 (US); Jonathan D. Brodie, Cos Cob, CT (US); Charles R. Ashby, Jr., Miller FOREIGN PATENT DOCUMENTS Place, NY (US) EP 54378O 11/1992 (73) Assignee: Brookhaven Science Associates, LLC, WO WO 93/23383 * 11/1993 Upton, NY (US) WO WO 98/OO130 1/1998 plOn, WO WO 99/21540 5/1999 WO WOOOf 44374 8/2000 (*) Notice: Subject to any disclaimer, the term of this WO WO 85. 2: patent is extended or adjusted under 35 WO WO OO/56301 * 9/2000 U.S.C. 154(b) by 0 days. WO WOOO/61140 10/2000 (21) Appl. No.: 09/853,392 cited by examiner (22) Filed: May 14, 2001 Primary Examiner William R. A. Jarvis 9 (74) Attorney, Agent, or Firm Margaret C. Bogosian (51) Int. Cl."7 .............................................. A61K 31/195 (57) ABSTRACT (52) U.S. Cl. ....................................................... 514/561 (58) Field of Search ................................. 514/561, 557, The present invention relates to the use of gamma Vinyl 514/620, 551, 455,326, 629 GABA (GVG) to treat obsessive-compulsive disorder (OCD) and OCD-related disorders, and to reduce or elimi (56) References Cited nate behaviors associated with obsessive-compulsive disor U.S. PATENT DOCUMENTS der (OCD) and OCD-related disorders. 4,761,429 A 8/1988 Blum et al. 6 Claims, No Drawings US 6,462,084 B1 1 2 TREATMENT FOR OBSESSIVE from OCD and OCD-related disorders by administering to a COMPULSIVE DISORDER (OCD) AND OCD mammal suffering from OCD and/or OCD-related disorders, RELATED DISORDERS USING GVG an effective amount of a pharmaceutical composition includ ing gamma vinylGABA (GVG). This invention was made with Government support 5 In a preferred embodiment, the present invention provides under contract number DE-AC02-98CH10886, awarded by a method for reducing or eliminating behaviors associated the U.S. Department of Energy. The Government has certain with OCD and OCD related disorders in a mammal suffering rights in the invention. from OCD and/or OCD-related disorders. The method com prises administering to Said mammal, an effective amount of BACKGROUND OF THE INVENTION a composition including gamma VinylGABA (GVG) or a This invention relates to the use of gamma vinyl-GABA pharmaceutically acceptable Salt thereof, or an enantiomer and other GABAergic agents to reduce or eliminate the or a racemic mixture thereof, wherein the effective amount Symptoms associated with obsessive-compulsive disorder reduces or eliminates behaviors associated with OCD and (OCD) and OCD-related disorders. Obsessive-Compulsive OCD-related disorders. Disorder effects a large portion of the population and can be 15 In another exemplary embodiment of the present disabling. invention, the method includes reducing or eliminating OCD has been linked to and can include one or more of behaviors associated with OCD and OCD-related disorders the following OCD-related disorders: obsessive behavior, in a mammal suffering from OCD. The method comprises compulsive behavior, general anxiety disorder (GAD), administering to the mammal, an effective amount of a pathological gambling, compulsive overeating, body dyS composition that increases central nervous System GABA morphic disorder (BDD), hypochondriasis, pathologic levels, wherein the effective amount is sufficient to reduce or grooming conditions (e.g. nail biting, skin picking, eliminate behaviors associated with OCD and OCD-related trichotillomania), kleptomania, pyromania, attention deficit disorders. hyperactivity disorder (AHDH), and any other impulse 25 AS a result of the present invention, methods of reducing control disorder. or eliminating behaviors associated with OCD and OCD The fact that many individuals with OCD suffer from one related disorders are provided which are based on pharma or more OCD-related disorders may be due to the discovery ceutical compositions which are highly effective in reducing that individuals who suffer from OCD or OCD-related or eliminating behaviors associated with OCD and OCD disorders, demonstrate Similar chemical imbalances in the related disorders in individuals suffering from OCD and brain and respond to Similar drug therapies. For example, OCD-related disorders. Some research Suggests that OCD involves problems with The pharmaceutical compositions of the present invention communication between the orbital cortex and the basal provide treatments for OCD and OCD-related disorders that are very well tolerated and more efficacious than the current ganglia of the brain. These brain Structures use the chemical treatments available. messenger Serotonin. Drugs that increase brain concentra 35 tions of serotonin have been used to treat OCD symptoms as Other improvements over the prior art which are provided well as symptoms of OCD-related disorders. by the present invention will be identified as a result of the In the past, OCD and OCD-related disorders have been following description which sets forth the preferred embodi treated with serotonin reuptake inhibitors (SRIs) such as ments of the present invention. The description is not in any Clomipramine, Fluoxetine, Fluvoxamine, Paroxetine, Ser 40 way intended to limit the Scope of the present invention, but traline and Citalopram. These medications increase the rather only to provide a working example of the present concentration of Serotonin in the brain. preferred embodiments. The Scope of the present invention Unfortunately, fewer than 20% of patents suffering from will be pointed out in the appended claims. OCD and OCD-related disorders treated with SRIs have DETAILED DESCRIPTION OF THE their OCD behavior eliminated. In addition, there are numer 45 INVENTION ous side effects identified with SRIs which include: nervousness, insomnia, restlessness, nausea, diarrhea, The present invention provides a highly effective method weight gain and Sexual problems. for treating OCD and OCD-related disorders, and reducing or eliminating behaviors associated with OCD and OCD Other research has Suggested that the role of neurochemi 50 related disorders in mammals. cal systems in OCD and OCD-related disorders is unclear Effective treatment of OCD and OCD-related disorders and that the Serotonergic abnormalities in OCD patients may includes temporary or permanent relief from the disorder or be a Secondary phenomenon. disorders that an affected mammal may Suffer from. Several approaches to treating OCD and OCD-related OCD and OCD-related Disorders disorders have been put forward, each based on a rather 55 AS used herein, OCD is defined to include obsessive different framework. Overlap exists among these behavior and compulsive behavior. OCD-related disorders approaches, indicating that the neurobiology of OCD and include, for example: general anxiety disorder (GAD), OCD-related disorders is consolidated. The development of pathological or compulsive gambling disorder, compulsive one effective treatment for OCD and all of the OCD-related eating, body dysmorphic disorder (BDD), hypochondriasis, disorders would be very beneficial. Accordingly, there is still 60 pathologic grooming conditions (e.g. nail biting, skin a need in the treatment of OCD and OCD-related disorders picking, trichotillomania), kleptomania, pyromania, atten to provide new methods which can reduce or eliminate the tion deficit hyperactivity disorder (ADHD) and other asSociated behaviors. impulse control disorders. Obsessive behavior is defined to include recurrent and SUMMARY OF THE PRESENT INVENTION 65 persistent thoughts, impulses or images that occur over and The present invention, which addresses the needs of the over again and feel out of an individual’s control. These prior art, provides methods for treating a mammal Suffering thoughts cause marked anxiety and distress. Obsessive US 6,462,084 B1 3 4 behavior can be accompanied by uncomfortable feelings, GVG does not bind to any receptor or reuptake complex, but Such as fear, disgust and doubt. increases endogenous intracellular GABA levels by Selec Compulsive behavior is defined to include acts or com tively and irreversibly inhibiting GABA-transaminase pulsions an individual with OCD performs over and over (GABA-T), the enzyme that normally catabolizes GABA. again, often according to certain rules. Compulsions are AS used herein GVG includes the racemic compound or repetitive behaviors or mental acts that an individual feels mixture which contains equal amounts of S(+)-gamma-Vinyl driven to perform in response to an obsession. GABA, and R(-)-gamma vinyl GABA. This racemic com pound of GVG is available as Vigabatrine) from Hoechst Behaviors associated with Generalized Anxiety Disorder Marion Roussel and can be obtained from Marion Merell (GAD) are defined to include chronic and excessive worry Dow of Cincinnati, Ohio. about events that are unlikely to occur. Individuals with GVG contains asymmetric carbon atoms and thus is GAD can also experience a number of other physical and capable of existing as enantiomers. The present invention emotional difficulties, including trembling, muscular aches embraces any enantiomeric form of GVG including the or Soreness, restlessness,
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