Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2001-02-14
2002-06-25
Jones, Dwayne C. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S439000, C514S443000
Reexamination Certificate
active
06410579
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the use of pramipexole or 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzo-thiazole or the (−)-enantiomers thereof, and the pharmacologically acceptable salts thereof, for the treatment of several nervous system disorders, including: Addictive Disorders, Psychoactive Substance Use Disorders, Nicotine Addiction or Tobacco Addiction resulting in Smoking Cessation.
BACKGROUND OF THE INVENTION
Pramipexole is a dopamine-D
3
/D
2
agonist the synthesis of which is described in European Patent 186 087 and its counterpart, U.S. Pat. No. 4,886,812. It is known primarily for the treatment of schizophrenia and Parkinson's disease. German patent application DE 38 43 227 suggests pramipexole lowers the plasma level of prolactin. The English abstract of this case states that among the numerous pitutary gland related disorders that may be treated with pramipexole, it might be useful to treat illnesses caused by DA receptor blockage or DA secretion inhibition caused by medicaments. Further, it is known from German patent application DE 39 33 738 that pramipexole can be used to decrease abnormal high levels of thyroid stimulating hormone (TSH). U.S. Pat. No. 5,112,842 discloses the transdermal administration of the compounds and transdermal systems containing these active compounds. The WO patent application PCT/EP 93/03389 describes pramipexole as an antidepressant agent. PCT application PCT/US95/15618 discloses neuroprotective effects of pramipexole. U.S. Pat. No. 5,001,861 describes the use of pramipexole for the treatment of Restless Legs Syndrome.
Scientists have also considered whether drugs like pramipexole might have useful properties to treat some forms of addiction. For example, see, A Carlsson, MF Piercey, Dopamine Receptor Subtypes in Neurological Psychiatric Diseases,
Clinical Neuropharmacology
, Vol. 18, Suppl. I, pp. S1-S5 (1995). R A Wise, D1- and D2-Type Contributions to Psychomotor Sensitization and Reward: Implications for Pharmacological Treatment Strategies,
Clinical Neuropharmacology
, Vol. 18, Suppl. I, pp. S-74-83 (1995). D C S Roberts, R Ranaldi, Effect of Dopaminergic Drugs on Cocaine Reinforcement,
Clinical Neuropharmacology
, Vol. 18, Suppl. I, pp. S84-S95 (1995). H D Kleber, Pharmacotherapy, Current and Potential, for the Treatment of Cocaine Dependence,
Clinical Neuropharmacology
, Vol. 18, Suppl. I, pp. S96-S109 (1995).
REFERENCES:
patent: 4886812 (1989-12-01), Griss et al.
patent: 5112842 (1992-05-01), Zierenberg et al.
patent: 6001861 (1999-12-01), Oertel
patent: 38 43 227 (1988-12-01), None
patent: 39 33 738 (1989-10-01), None
patent: 0186087 (1985-12-01), None
patent: 0417 637 (1991-03-01), None
patent: WO94/13287 (1994-06-01), None
patent: WO96/18395 (1996-06-01), None
patent: WO 0122820 (2001-04-01), None
S. Caine, et al. “D3-receptor test in vitro predicts decreased cocain self-administration in rats”, XP002168920 & NeuroReport (1997), 8(9-10), 2373-2377 abstract.
A.Carlsson and M.F.Piercey, “Dopamine-Receptor Subtypes in Neurological and Psychiatic Disease”, Clinical Neuropharmacology, 1995, vol. 18, Suppl. 1, pp S1-S5.
H.D.Kleber, “Pharmacotherapy, Current and Potential, for the Treatment of Cocaine Dependence”, Clinical Neuropharmacology, 1995, vol. 18, Suppl. 1, pp S96-S109.
Ma J J, et al. “The Behavioral Effects of Pramipexole, A Novel Dopamine Receptor Agonist”, European Journal of Pharmacology, 1997, vol. 324, No. 1, pp. 31-37.
D.C.S. Roberts and R. Ranaldi, “Effect of Dopaminergic Drugs on cocaine Reinforcement”, Clinical Neuropharmacology, 1995, vol. 18, Suppl. 1, pp. S84-S95.
R.A. Wise, “D1- and D2-Type Contributions to Psychomoter Sensitization and Reward: Implications for Pharmacological Treatment Strategies”, Clinical Neuropharmacology, 1995, vol. 18, Suppl. 1, pp S74-S83.
Fong Wong Erik Ho
Marshall Robert Clyde
Von Voigtlander Philip F.
Delacroix-Muirheid C.
Jones Dwayne C.
Pharmacia & Upjohn Company
Wootton Thomas A.
Zhang Austin W.
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