Treatment of Addiction and Impulse-Control Disorders Using PDE7 Inhibitors

a technology of phosphodiesterase and inhibitors, applied in the direction of heterocyclic compound active ingredients, biocide, drug compositions, etc., can solve the problems of alcohol abuse, affecting work performance, social problems and adverse consequences, and affecting work performance, so as to prevent relapse of addictive or compulsive behavior, and prevent relapse of addictive behavior

Inactive Publication Date: 2012-05-10
OMEROS CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0035]The present invention provides a method of preventing relapse use of an addictive agent or practice of an addictive or compulsive behavior, by treating a subject who has undergone a period of abstinence from, or limited or reduced use of, the addictive agent or the addictive or compulsive behavior by administering a PDE7 inhibitor to the subject. The present invention also provides a method of preventing relapse of an addictive or compulsive behavior associated with a primary impulse-control disorder, by treating a subject who has undergone a period of remission from, or limited or reduced practice of, the addictive or compulsive behavior associated with the primary impulse-control disorder by administering a PDE7 inhibitor to the subject. The present invention also provides a method of preventing relapse of addictive or compulsive behavior associated with an obsessive-compulsive disorder, by treating a subject who has undergone a period of remission from, or limited or reduced practice of, the addictive or compulsive behavior associated with the obsessive-compulsive disorder by administering a PDE7 inhibitor to the subject. Additional therapeutic agents that contribute to the effect prevention of relapse can be administered with the PDE7 inhibitor. This treatment can be administered to subjects that have previously been treated with a different anti-addictio

Problems solved by technology

Additionally, alcoholism leads to serious liver and cardiovascular disease and generates dependence resulting in severe mental disorders, social problems and adverse consequences including the division of families, tragic accidents and the reduction of work performance.
Globally, alcohol abuse leads to about 1.8 million deaths per year.
Compulsive behavior towards the consumption of alcohol is a core symptom of the disorder.
However, despite some promising results none of these medications, including naltrexone, is of sufficient efficacy in alcoholism and prognosis remains poor.
Cigarette smoking is associated with 430,000 deaths per year in the US alone and is estimated to cost the nation 80 billion dollars yearly in health care costs.
Smoking also causes lung diseases such as chronic bronchitis and emphysema; exacerbates asthma symptoms; and increases the risk of heart disease, including stroke, heart attack, vascular disease, and aneurysm.
Most therapies developed for nicotine addiction have shown only moderate success in preventing relapse, leading to a high failure rate in attempts to quit smoking.
Acute effects of marijuana use include memory and learning problems, distorted perception, difficulty problem solving, loss of coordination, and increased heart rate.
Long term abuse can cause the same respiratory problems observed in tobacco smokers, such as daily cough, phlegm production, increased risk of lung infections, and an increased chance of developing cancer of the head, neck and lungs.
Long term marijuana use can result in addiction with compulsive use that interferes with daily activities.
Cravings and withdrawal symptoms, such as irritability, increased aggression, sleeplessness, and anxiety make it difficult for addicts to stop using marijuana.
There are no pharmaceutical treatments available for treating marijuana addiction and relapse.
Furthermore,

Method used

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  • Treatment of Addiction and Impulse-Control Disorders Using PDE7 Inhibitors
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  • Treatment of Addiction and Impulse-Control Disorders Using PDE7 Inhibitors

Examples

Experimental program
Comparison scheme
Effect test

example 1

PDE7 Inhibition Reduces Relapse to Cocaine Addiction and Reduces Chronic Cocaine Self-Administration

[1216]The ability of PDE7 inhibition to reduce cocaine use was demonstrated in a rat model of cocaine addiction. Cocaine hydrochloride (obtained from the National Institute on Drug Abuse, Bethesda, Md.) was dissolved in sterile physiological saline at a concentration of 0.25 mg / 0.1 ml. Drug or vehicle solution was infused at a volume of 0.1 ml over 4 s. Two PDE7 inhibitors in accordance with Formulas 1A (OMS182056) and 1B (OMS181869) herein above, were tested for effects on cocaine self-administration. PDE7 inhibitors were given orally (OS) via gavage procedure 12 hours and 1 hour before the beginning of cocaine self-administration.

[1217]Male Wistar rats weighing between 180 and 200 g at the time of arrival in the lab were used. The rats were housed in groups of three in a humidity- and temperature-controlled (22° C.) vivarium on a 12 h: 12 h reverse light / dark cycle (on, 17:00; off, ...

example 2

PDE7 Inhibition Reduces Binge Eating in Response to Stress

[1230]Reinstatement of binge eating behavior has been obtained in experimental animals through a combination of repeated food restriction and stress. (Cifani et al, Psychopharmacology 204:113-125 (2009). For the present invention, stress-induced binge eating was tested as in Cifani. Rats were housed in individual cages and were given chow and water ad libitum for two weeks prior to the experiment. During the experiment, rats were given one of two food sources: standard rat food pellets or Highly Palatable Food (HPF); a mixture of 52% Nutella™ chocolate cream, 33% rat food pellets, and 15% water (5.33 kcal / g; 56%, 31%, and 7% from carbohydrate, fat, and protein, respectively).

[1231]Rats were divided into four groups. Individual groups were subjected to the following 8-day cycles, three consecutive times. Rats were given PDE7 or vehicle on day 25.

[1232](1) Control group—Non-restricted, non-stressed (NR+NS). Rats had chow ad lib...

example 3

PDE7 Inhibition Alleviates Nicotine Addiction

[1239]The ability of PDE7 inhibition to reduce nicotine use was demonstrated in a rat model of nicotine addiction. Male Wistar rats weighing between 180 and 200 g at the time of arrival in the lab were used. The rats were housed in groups of three in a humidity- and temperature-controlled (22° C.) vivarium on a 12 h: 12 h reverse light / dark cycle (on, 17:00; off, 05:00) with ad libitum access to food and water.

[1240]Rats were surgically implanted with jugular catheters and allowed to recover for one week. The animals underwent daily two-hour (short access) or six-hour (long access) training sessions in which every three active lever presses triggered the delivery of 0.03 mg of nicotine. After achieving a stable rate of active lever pressing, the animals were injected i.p. with vehicle or drug (either OMS182401 or OMS182399, another PDE7 inhibitor in accordance with Formula 6 above) fifteen minutes before the test session. The measured rea...

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Abstract

This disclosure is directed to treatment of addictions and primary impulse-control disorders using phosphodiesterase 7 (PDE7) inhibitors, alone or in combination with other therapeutic agents.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS[0001]This application claims the benefit of Application Nos. 61 / 411,431, filed Nov. 8, 2010, 61 / 411,437, filed Nov. 8, 2010 and 61 / 482,944, filed May 5, 2011, the disclosures of which are incorporated herein by reference in their entirety.I. FIELD OF THE INVENTION[0002]This disclosure is directed to prevention and treatment of substance and behavioral addictions using phosphodiesterase 7 (PDE7) inhibitors, alone or in combination with other therapeutic agents or addictive agents.II. BACKGROUND OF THE INVENTION[0003]The World Health Organization (WHO) defines substance addiction as using a substance repeatedly, despite knowing and experiencing harmful effects. Substance addiction is a chronic, relapsing disease characterized by a loss of control over drug use, compulsive drug seeking and craving for a substance, use that persists despite negative consequences, and physical and / or psychological dependence on the substance. Substance addiction t...

Claims

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Application Information

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IPC IPC(8): A61K31/55A61K31/5377A61K31/551A61K31/4439A61K31/4162A61K31/4178A61K31/485A61K31/454A61K31/44A61P25/30A61P25/36A61P25/32A61P25/34A61P25/00A61P25/24A61P25/18A61P25/08A61K31/519
CPCA61K31/00A61K31/135A61K31/55A61K31/519A61K31/517A61K31/505A61K31/4985A61K31/485A61K31/454A61K31/137A61K31/197A61K31/337A61K31/357A61K31/381A61K31/385A61K31/4015A61K31/4025A61K31/4178A61K31/44A61K2300/00A61K31/045A61K31/085A61K31/122A61K31/216A61K31/222A61K31/4162A61K31/4188A61K31/42A61K31/433A61K31/437A61K31/4409A61K31/4439A61K31/496A61K31/506A61K31/52A61K31/527A61K31/5377A61K31/5383A61K31/541A61K31/542A61K45/00A61K31/195A61K31/435A61K31/551A61P25/00A61P25/08A61P25/18A61P25/22A61P25/24A61P25/30A61P25/32A61P25/34A61P25/36A61P43/00A61K31/443A61K31/53A61K31/554
Inventor DEMOPULOS, GREGORY A.GAITANARIS, GEORGE A.
Owner OMEROS CORP
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