Use of (1R,5S)-(+)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane in the treatment of conditions affected by monoamine neurotransmitters
The present invention relates to (1R,5S)-(+)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane and pharmaceutical compositions thereof, and methods employing their use in the treatment of conditions affected by monoamine neurotransmitters, including ADHD and substance abuse.
1. A method for treating ADHD or a related behavioral disorder in a subject comprising administering to a subject in need of treatment for ADHD or a related behavioral disorder a pharmaceutical composition comprising an effective amount of (1R,5S)-(+)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane or a pharmaceutically acceptable salt thereof in a bi-layer tablet dosage form for sustained delivery of the (1R,5S)-(+)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane or of the pharmaceutically acceptable salt, wherein:
the bi-layer table comprises an immediate release and a slow-release layer.
2. The method according to claim 1 , wherein the ADHD is selected from the group consisting of Attention Deficit Hyperactivity Disorder-predominantly hyperactive-impulsive subtype, Attention Deficit Hyperactivity Disorder-predominantly inattentive subtype, and Attention Deficit Hyperactivity Disorder-combined subtype.
3. The method according to claim 1 , wherein the related behavioral disorder is selected from the group consisting of Conduct Disorder and Oppositional Defiant Disorder.
4. The method according to claim 1 , wherein the subject is a human child, adolescent, or adult.
5. The method according to claim 4 , wherein the subject is an adult.
6. The method according to claim 4 , wherein the subject is a child.
7. The method according to claim 1 , wherein the slow-release layer includes pH sensitive polymers.
8. The method according to claim 7 , wherein the pH sensitive polymers have a high degree of swelling in contact with water or aqueous media such as the stomach contents.
9. The method according to claim 1 , wherein the effective amount is effective to decrease ADHD symptoms.
10. The method according to claim 9 , wherein the effective amount is effective to decrease the subject's score on an ADHD rating scale.
11. The method according to claim 1 , wherein the (1R,5S)-(+)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane or pharmaceutically acceptable salt thereof has no more than 2% w/w of the corresponding (−) enantiomer.
12. The method according to claim 1 , wherein the (1R,5S)-(+)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane or pharmaceutically acceptable salt thereof has no more than 1% w/w of the corresponding (−) enantiomer.
13. The method according to claim 1 , wherein the pharmaceutically acceptable salt is a hydrochloride salt.