IP Library › Granted Patent US 10,188,613
Granted Patent B2
US 10,188,613 · App. 15/970,656 · Granted Jan 29, 2019

Exo-S-mecamylamine formulation and use in treatment

Inventors: Douglas Shytle (Largo, FL); Paul R. Sanberg (Spring Hill, FL); Mary Newman (Valrico, FL); Archie A. Silver (Tampa, FL)
Assignee: UNIVERSITY OF SOUTH FLORIDA
A61K31/13A61K9/0019C07C211/38
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Quick Facts
Patent No.
US 10,188,613
App. No.
15/970,656
Granted
Jan 29, 2019
Kind
B2
Abstract

A pharmaceutical composition includes a therapeutically effective amount of exo-S-mecamylamine or a pharmaceutically acceptable salt thereof, substantially free of exo-R-mecamylamine in combination with a pharmaceutically acceptable carrier. Preferably the amount is about 0.5 mg to about 20 mg. Medical conditions are treated by administering a therapeutically effective amount of exo-S-mecamylamine or a pharmaceutically acceptable salt thereof, substantially free of its exo-R-mecamylamine, said amount being sufficient to ameliorate the medical condition. The medical conditions include but are not limited to substance addiction (involving nicotine, cocaine, alcohol, amphetamine, opiate, other psychostimulant and a combination thereof), aiding smoking cessation, treating weight gain associated with smoking cessation, hypertension, hypertensive crisis, Tourette's Syndrome and other tremors, cancer (such as small cell lung cancer), atherogenic profile, neuropsychiatric disorders (such as bipolar disorder, depressoin, an anxiety disorder, schizophrenia, a seizure disorder, Parkinson's disease and attention deficit hyperactivity disorder), chronic fatigue syndrome, Crohn's disease, autonomic dysreflexia, and spasmogenic intestinal disorders.

Claims (14)

1. A method of treating a medical condition selected from the group consisting of substance addiction, Tourette's Syndrome, a neuropsychiatric disorder, depression, and anxiety, in a human in need thereof, comprising orally administering a therapeutically effective amount of a pharmaceutical composition to the human, wherein the pharmaceutical composition comprises:

exo-S-mecamylamine or pharmaceutically acceptable salt thereof substantially free of exo-R-mecamylamine or a pharmaceutically acceptable salt thereof,

one or more pharmaceutically acceptable carriers; and

a pharmaceutical adjuvant, wherein the pharmaceutical composition has a higher overall therapeutic index than the same amount of exo-R-mecamylamine substantially free of exo-S-mecamylamine.

2. The method of claim 1 , wherein the pharmaceutical composition is a unit dosage form.

3. The method of claim 2 , wherein the unit dosage form is selected from the group consisting of a tablet, capsule, soft gelatin capsule, hard gelatin capsule, powder, lozenge, gum, emulsion, suspension, syrup, and solution.

4. The method of claim 1 , wherein the pharmaceutical composition is formulated to provide rapid, sustained, or delayed release of the exo-S-mecamylamine or a pharmaceutically acceptable salt thereof.

5. The method of claim 1 , wherein the effective amount of exo-S-mecamylamine or pharmaceutically acceptable salt thereof is from about 0.001 mg/kg to about 6 mg/kg per day.

6. The method of claim 1 , wherein the effective amount of exo-S-mecamylamine or pharmaceutically acceptable salt thereof is from about 0.01 mg/kg to about 1.5 mg/kg per day.

7. The method of claim 1 , wherein the medical condition is substance addiction.

8. The method of claim 1 , wherein the medical condition is Tourette's Syndrome.

9. The method of claim 1 , wherein the medical condition is a neuropsychiatric disorder.

10. The method of claim 1 , wherein the medical condition is depression.

11. The method of claim 1 , wherein the medical condition is anxiety.

Continuity (10)
Continuation 15456934 · Mar 13, 2017
Continuation 14205721 · Mar 12, 2014
Continuation 12886887 · Sep 21, 2010
Continuation 12651813 · Jan 4, 2010
Continuation 11278770 · Apr 5, 2006
Continuation 10441947 · May 19, 2003
Continuation 09882935 · Jun 15, 2001
Continuation In Part PCTUS9930153 · Dec 16, 1999
Provisional Application 60112534 · Dec 16, 1998
Related Publication 20180250244A1 · Sep 6, 2018