Pharmaceutical combination and its use for treating synucleinopathties
The present invention describes the combination of a 6-propylamino-4,5,6,7-tetrahydro-1,3-benzothiazole-2-amine or of a pharmaceutically acceptable salt or solvate thereof with fluoxetine or a pharmaceutically acceptable salt or solvate thereof, for use for treating a synucleinopathy such as Parkinson's disease, Lewy body disease, mutations in the glucocerebrosidase gene, or multiple system atrophy.
1. A method for treating a patient suffering from a synucleinopathy which comprises treating said patient with fluoxetine or a pharmaceutically acceptable salt or solvate thereof in combination with a 6-propylamino-4,5,6,7-tetrahydro-1,3-benzothiazole-2-amine or of a pharmaceutically acceptable salt or solvate thereof.
2. The method of claim 1 wherein said synucleinopathy is selected from the group consisting of Parkinson's disease, Lewy body disease, Alzheimer's disease, mutations in the glucocerebrosidase gene, and multiple system atrophy.
3. The method of claim 1 , wherein said 6-propylamino-4,5,6,7-tetrahydro-1,3-benzothiazole-2-amine or pharmaceutically acceptable salt or solvate thereof is (S)-6-propylamino-4,5,6,7-tetrahydro-1,3-benzothiazole-2-amine dihydrochloride monohydrate.
4. The method of claim 1 , wherein said fluoxetine is formulated in a pharmaceutical composition in dosage unit form comprising said fluoxetine in an amount per unit form of from 2 mg to 90 mg and said 6-propylamino-4,5,6,7-tetrahydro-1,3-benzothiazole-2-amine is formulated in a pharmaceutical composition in dosage unit form comprising said 6-propylamino-4,5,6,7-tetrahydro-1,3-benzothiazole-2-amine in an amount equivalent to from 0.125 mg to 3000 mg of pramipexole dihydrochloride monohydrate, said amount including a (S)-enantiomer amount equivalent to from 0.125 mg to 20 mg of pramipexole dihydrochloride monohydrate.
5. The method of claim 4 , wherein said fluoxetine or pharmaceutically acceptable salt thereof is formulated in a pharmaceutical composition in dosage unit form comprising said fluoxetine or pharmaceutically acceptable salt thereof in an amount per unit form of from 2 mg to 40 mg in an IR- or ER-formulation.
6. The method of claim 4 , wherein said fluoxetine or pharmaceutically acceptable salt thereof is formulated in a pharmaceutical composition in dosage unit form comprising said fluoxetine or pharmaceutically acceptable salt thereof in an amount per unit form of 90 mg in an ER-formulation to be administered once a week.
7. The method of claim 4 , wherein said fluoxetine or pharmaceutically acceptable salt thereof is administered at a daily dose equivalent to from 4 mg to 40 mg of fluoxetine base and said 6-propylamino-4,5,6,7-tetrahydro-1,3-benzothiazole-2-amine or of a pharmaceutically acceptable salt or solvate thereof is administered at a daily dose equivalent to from 1.5 mg to 3000 mg of pramipexole dihydrochloride
monohydrate, said daily dose including a (S)-enantiomer daily dose equivalent to from 1.5 mg to 6 mg of pramipexole dihydrochloride monohydrate.