Compositions for controlling food intake and uses therefor

9,610,285

14/358418

November 16, 2012

The present invention is directed to a combination treatment for: individuals who meet the definition of food addiction; individuals who are overweight or obese (e.g., a BMI≧25); individuals who have a binge eating disorder; or individuals who engage in a binge eating behavior. In particular embodiments, the combination therapy reduces the intake of fatty foods, sugar-rich foods, or foods that are both fatty and sugar-rich (e.g., fast foods).

UNIVERSITY OF FLORIDA RESEARCH FOUNDATION, INCORPORATED (Gainesville, FL, US)

UNIVERSITY OF FLORIDA RESEARCH FOUNDATION, INCORPORATED (Gainesville, FL, US)

1. A pharmaceutical composition comprising a therapeutically effective amount of baclofen or a pharmaceutically acceptable salt thereof; and naltrexone or a pharmaceutically acceptable salt thereof, wherein the therapeutically effective amount of naltrexone or a pharmaceutically acceptable salt thereof is an amount of about 25 to 100 milligrams and baclofen or a pharmaceutically acceptable salt thereof is an amount between about 15 and about 120 milligrams.

2. The composition of claim 1 , wherein said composition further comprises a therapeutically effective amount of extended release bupropion or bupropion or a pharmaceutically acceptable salt thereof.

3. The composition according to claim 2 , wherein the composition comprises: naltrexone, or a pharmaceutically acceptable salt thereof, in an amount of about 25 to 100 milligrams, baclofen, or a pharmaceutically acceptable salt thereof, in an amount between about 15 and about 120 milligrams and bupropion or bupropion extended release, or pharmaceutically acceptable salts thereof in an amount of between 75 milligrams and 450 milligrams.

4. A method for reducing the intake of fatty foods, sugar rich foods, or foods that are both fatty and sugar-rich comprising the administration of a composition according to claim 1 to an individual whose diet includes fatty foods, sugar rich foods, or foods that are both fatty and sugar-rich.

5. The method according to claim 4 , wherein said individual is an individual meeting the definition of food addiction, an individual who is obese or overweight, has a binge-eating disorder or an individual that engages in binge eating behavior.

6. The pharmaceutical composition of claim 1 , wherein the composition comprises synergistic amounts of baclofen and naltrexone.

7. The pharmaceutical composition of claim 6 , wherein the composition further comprises extended release bupropion or bupropion or a pharmaceutically acceptable salt thereof.

2002/0044968 April 2002 van Lengerich
2007/0072899 March 2007 Johnson et al.
2007/0099947 May 2007 Dean, III
2007/0129283 June 2007 McKinney et al.
2008/0293777 November 2008 Erlanson et al.

Colombo et al., Drug and Alcohol Dependence, 2005, vol. 77, pp. 87-91. cited by examiner
Stromberg, “The effect of baclofen alone and in combination with naltrexone on ethanol consumption in the rat”, Pharmacology, Biochemistry and Behavior, 2004, vol. 78, pp. 743-750. cited by examiner
Williams, “Medications for Treating Alcohol Dependence”, American Family Physician, 2005, vol. 72(9), pp. 1775-1780. cited by examiner
Greenway et al., “Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial”, Lancet, published online Oct. 2010, vol. 376, pp. 595-605. cited by examiner
Addolorato, G. et al. “Baclofen Efficacy in Reducing Alcohol Craving and Intake: A Preliminary Double-Blind Randomized Controlled Study,” Alcohol & Alcoholism, 2002, pp. 504-508, vol. 37, No. 5. cited by applicant
Alger, S. A. et al. “Effect of a tricyclic antidepressant and opiate antagonist on binge-eating behavior in normoweight bulimic and obese, binge-eating subjects,” Am J Clin Nutr, 1991, pp. 865-871, vol. 53. cited by applicant
Arima, H. et al. “Positive Effect of Baclofen on Body Weight Reduction in Obese Subjects: A Pilot Study,” Inter Med, 2010, pp. 2043-2047, vol. 49. cited by applicant
Buda-Levin, A. et al. “Baclofen reduces fat intake under binge-type conditions,” Physiology & Behavior, 2005, pp. 176-184, vol. 86. cited by applicant
Colombo, G. et al. “Effect of the combination of naltrexone and baclofen, on acquisition of alcohol drinking behavior in alcohol-preferring rats,” Drug and Alcohol Dependence, 2005, pp. 87-91, vol. 77. cited by applicant
Dym, C. T. et al. “Genetic Variance Contributes to Dopamine and Opioid Receptor Antagonist-Induced Inhibition of Intralipid (Fat) Intake in Inbred and Outbred Mouse Strains,” Brain Res., Feb. 26, 2010, pp. 1-17. cited by applicant
Greenway, F. L. et al. “Rational design of a combination medication for the treatment of obesity,” Obesity (Silver Spring), Jan. 2009, pp. 30-39, vol. 17, No. 1, Abstract only. cited by applicant
Kiefer, F. et al. “Comparing and Combining Naltrexone and Acamprosate in Relapse Prevention of Alcoholism,” Arch Gen Psychiatry, 2003, pp. 92-99, vol. 60. cited by applicant
“Orexigen(R) Therapeutics and Takeda Enter Into Partnership to Commercialize Contrave(R) in North America,” Orexigen Therapeutics Inc.—Investor Relations—Press Release, pp. 1-3. Sep. 2, 2010. cited by applicant
Liu, Y. et al. “Food Addiction and Obesity: Evidence from Bench to Bedside” Journal of Psychoactive Drugs, Jun. 2010, pp. 135-145, vol. 42, No. 2. cited by applicant
Written Opinion in International Application No. PCT/US2012/065486, Feb. 28, 2013, pp. 1-7. cited by applicant

edspgr.09610285