Method of treating neuropathic pain with a synergistic pharmaceutical composition comprising palmitoylethanolamide and L-acetylcarnitine

1. A method of treating neuropathic pain, comprising:

administering to a patient a synergistic pharmaceutical daily dosage form comprising:

palmitoylethanolamide (PEA), and

L-acetylcarnitine (LAC) in a finely pulverized form; and

the pharmaceutical daily dosage form is for oral or buccal use, and palmitoylethanolamide (PEA) and L-acetylcarnitine (LAC) are contained in the daily dosage form in doses not exceeding 5 mg/kg of the palmitoylethanolamide (PEA) and not exceeding 10 mg/kg of L-acetylcarnitine (LAC);

wherein the pharmaceutical daily dosage form has palmitoylethanolamide in a weight percentage between 20 and 35%, L-acetylcarnitine in a weight percentage between 20 and 55% and one or more compounds with antioxidant activity in a total weight percentage ranging between 0 and 20%, and

a combination of the palmitoylethanolamide, the L-acetylcarnitine and the one or more compounds with antioxidant activity does not exceed a weight percent of 100%.

2. The method of claim 1 , wherein the one or more compounds with the antioxidant activity is selected from the group consisting of polyphenols, alpha-lipoic acid, and L-acetylcysteine.

3. The method of claim 2 , wherein the one or more compounds with the antioxidant activity, comprises a polyphenol selected from the group consisting of polydatin, resveratrol, luteolin, quercetin, and rutin.

4. The method of claim 1 , wherein the synergistic pharmaceutical daily dosage form further comprises:

an active dosage of palmitoylethanolamide in an amount of 5 mg/kg;

an active dosage of L-acetylcarnitine in an amount of 10 mg/kg; and

an active dosage of the one or more compounds with an antioxidant activity in an amount of about 0.5 mg/kg such that the synergistic pharmaceutical daily dosage form is one of a dosage tablet, a capsule, or liquid form of a pharmaceutical composition.

5. The method of claim 1 , wherein the one or more compounds with the antioxidant activity is co-micronized with the palmitoylethanolamide.

6. The method of claim 1 , wherein the neuropathic pain results from a disease selected from:

both acute and chronic painful peripheral neuropathies of dysmetabolic, compressive, traumatic, toxic, infectious, iatrogenic origin;

pain associated with vertebral column and spinal cord diseases of traumatic, dysmetabolic, degenerative, infectious, iatrogenic origin;

pain associated with small fibre diseases of infectious, traumatic, dysmetabolic, iatrogenic origin;

acute and/or chronic pain associated with diseases in the pelvic area, such as Endometriosis, Interstitial Cystitis, Recurrent Cystitis, Irritable Bowel Syndrome, Prostatites, Vaginites, Vulvovaginites, primary and secondary Dysmenorrhoea, Vulvodynias, Vestibulodynias;

pain associated with traumatic and degenerative joint diseases; and

pain associated with arthritic diseases.

7. The method of claim 4 , wherein the pharmaceutical composition is for human or veterinary use.

8. The method of claim 1 , wherein the palmitoylethanolamide is in ultra-micronized form (PEA-um) with a particle size ranging between 0.8 and 6.0 microns.

9. A method of treating neuropathic pain, comprising:

administering to a patient a dosage tablet, a capsule, or a liquid form of a synergistic pharmaceutical composition, wherein each dosage tablet, capsule, or liquid form of the pharmaceutical composition comprises:

an active dosage of palmitoylethanolamide in an amount not to exceed 5 mg/kg;

an active dosage of L-acetylcarnitine in an amount not to exceed 10 mg/kg; and

an active dosage of one or more compounds with an antioxidant activity in an amount not to exceed 0.5 mg/kg such that each dosage tablet, capsule, or liquid form of the synergistic pharmaceutical composition has palmitoylethanolamide in weight percentages ranging between 20 and 35%, L-acetylcarnitine in weight percentages between 20 and 55%, and the one or more compounds with the antioxidant activity in total weight percentages not to exceed 20%,

wherein the combination of palmitoylethanolamide, L-acetylcarnitine and the one or more compounds with the antioxidant activity does not exceed a weight percent of 100% and a combined amount of palmitoylethanolamide (PEA) and L-acetylcarnitine (LAC) does not exceed about 1 g per each dosage tablet, capsule, or liquid form of the pharmaceutical composition.

10. The method of claim 9 , wherein said palmitoylethanolamide is in non-micronized form with a particle size ranging between 50.0 and 100.0 μm, in micronized form (PEA-m) with a particle size ranging between 2.0 and 10.0 μm, or in ultra-micronized form (PEA-um) with a particle size ranging between 0.8 and 6.0 μm, or in a mixture of such forms.

11. The method of claim 10 , wherein said L-acetylcarnitine is in a finely pulverized form.

12. The method of claim 9 , wherein the one or more compounds with the antioxidant activity is selected from the group consisting of polyphenols, alpha-lipoic acid, and L-acetylcysteine.

13. The method of claim 9 , wherein the one or more compounds with the antioxidant activity, comprises a polyphenol selected from the group consisting of polydatin, resveratrol, luteolin, quercetin, and rutin.

14. The method of claim 10 , wherein the one or more compounds with the antioxidant activity is co-micronized with palmitoylethanolamide.

15. The method of claim 9 , wherein the pharmaceutical composition is for human or veterinary use.

16. The method of claim 9 , wherein the neuropathic pain results from a disease selected from:

both acute and chronic painful peripheral neuropathies of dysmetabolic, compressive, traumatic, toxic, infectious, iatrogenic origin;

pain associated with vertebral column and spinal cord diseases of traumatic, dysmetabolic, degenerative, infectious, iatrogenic origin;

pain associated with small fibre diseases of infectious, traumatic, dysmetabolic, iatrogenic origin;

acute and/or chronic pain associated with diseases in the pelvic area, such as Endometriosis, Interstitial Cystitis, Recurrent Cystitis, Irritable Bowel Syndrome, Prostatites, Vaginites, Vulvovaginites, primary and secondary Dysmenorrhoea, Vulvodynias, Vestibulodynias;

pain associated with traumatic and degenerative joint diseases; and

pain associated with arthritic diseases.