Concomitant use of 2-pentadecyl-2-oxazoline and butyrate or its salts in the treatment of epilepsy

Abstract

The present invention provides compounds and compositions for use in the treatment of epilepsy and related psychiatric comorbidities. [Solution] The subject of the present invention is the use of 2-pentadecyl-2-oxazoline (also known as PEA-OXA) together with butyric acid in acid or salt form in the treatment of epilepsy and associated psychiatric comorbidities (e.g., social isolation). In particular, the present invention relates to PEA-OXA for use in the prevention and treatment of epileptogenesis and epilepsy-related comorbidities, e.g., limitations in social interaction, in humans and animals, wherein PEA-OXA is administered together with or in combination with butyric acid or a salt thereof, and such administration is separate, together or simultaneously.

Claims

1. 2-pentadecyl-2-oxazoline (PEA-OXA) for use in the prevention and treatment of epileptogenic and epilepsy-related comorbidities, wherein PEA-OXA is administered together with or in combination with butyrate or a salt thereof, and such administration is separate, together or simultaneously.

2. 2-pentadecyl-2-oxazoline for use according to claim 1 in the management of epileptic seizures.

3. 2-pentadecyl-2-oxazoline for use according to claim 1 or 2, wherein, if butyric acid is in salt form, the salt is preferably selected from a sodium salt, potassium salt, calcium salt, magnesium salt, lysine salt, arginine salt, or a combination thereof.

4. 2-pentadecyl-2-oxazoline for use according to any one of claims 1 to 3, wherein PEA-OXA and butyric acid or a salt thereof are administered in a weight ratio of butyric acid or a salt thereof / PEA-OXA of 1:1 to 7:1, preferably 2:1 to 5:1, more preferably 2.5:1 to 3.5:1, and even more preferably about 3:

1.

5. 2-pentadecyl-2-oxazoline for use according to any one of claims 1 to 4, in both a combination therapy and a composition of PEA-OXA and butyric acid or a salt thereof, the daily dose of PEA-OXA is at least 100 mg / day to 1500 mg / day, preferably 200 mg / day to 1200 mg / day, and the preferred daily dose of butyric acid or a salt thereof is at least 300 mg / day to 3500 mg / day, more preferably 400 mg / day to 3000 mg / day.

6. 2-pentadecyl-2-oxazoline for use according to any one of claims 1 to 5, wherein 2-pentadecyl-2-oxazoline and butyric acid or a salt thereof exert a synergistic effect.

7. A pharmaceutical or veterinary composition comprising PEA-OXA and butyric acid or a salt thereof, wherein PEA-OXA and butyric acid or a salt thereof are present in a weight ratio of 1:1 to 7:1, preferably 2:1 to 5:1, more preferably 2.5:1 to 3.5:1, and even more preferably about 3:1 for butyric acid or salt thereof / PEA-OXA, and the amount of PEA-OXA per dose unit is 100 mg to 1500 mg, preferably 200 mg to 1200 mg.

8. The composition according to claim 7, further comprising palmitoylethanolamide (PEA) in an amount of 100 mg to 1500 mg per dose unit.

9. A dietary composition, nutritional supplement, complementary feed and special medical food (FSMP) comprising PEA-OXA and butyric acid or a salt thereof, wherein PEA-OXA and butyric acid or a salt thereof are present in a weight ratio of butyric acid or a salt thereof / PEA-OXA of 1:1 to 7:1, preferably 2:1 to 5:1, more preferably 2.5:1 to 3.5:1, and even more preferably about 3:1, and the amount of PEA-OXA per dose unit is 100 mg to 1500 mg, preferably 200 mg to 1200 mg.

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