Pharmaceutical composition for treating migraine
The present application relates to a method of treating migraine or cluster headache in a human patient, said method comprising administering subcutaneously composition comprising sumatriptan or its pharmaceutically acceptable salt, in an amount equivalent to 3 mg sumatriptan base.
1. A method of treating acute migraine in a patient, the method comprising:
subcutaneously administering by autoinjector a composition to the patient, the composition comprising an aqueous solution comprising 4.2 mg sumatriptan succinate and sodium chloride in a range of 4.15 mg to 4.2 mg in a total volume of 0.5 mL;
wherein the composition has osmolality between 275 to 315 mOsm/kg; and
wherein the administration of the compositions results in a system exposure in the patient characterized by at least one of the following plasma profiles:
C max of about 35 ng/mL to about 57 ng/mL;
AUC 0-2 of about 30 ng·hr/mL to about 50 ng·hr/mL; and
AUC 0-inf of about 43 ng·hr/mL to about 70 ng·hr/mL.
2. The method of claim 1 , wherein the composition has a pH of about 4.2 to 5.3.
3. The method of claim 1 , wherein the patient is suffering from acute migraine.
4. The method of claim 3 , wherein the patient is suffering from acute migraine with aura.
5. The method of claim 3 , wherein the patient is suffering from acute migraine without aura.
6. The method of claim 1 , wherein the autoinjector comprises a 0.5 mL prefilled, ready-to-use, single dose, disposable auto-injector.
7. The method of claim 1 , wherein the maximum recommended frequency of administration is not more than four times a day.
8. A method of treating acute migraine in a patient, the method comprising:
subcutaneously injecting a composition to the patient, the composition comprising an aqueous solution comprising 4.2 mg sumatriptan succinate and sodium chloride a range of 4.15 mg to 4.2 mg in a total volume of 0.5 mL;
wherein the composition has osmolality between 275 to 315 mOsm/kg; and
wherein the injection results in a system exposure in the patient characterized by at least one of the following plasma profiles:
C max of about 35 ng/mL to about 57 ng/mL;
AUC 0-2 of about 30 ng·hr/mL to about 50 ng·hr/mL; and
AUC 0-inf of about 43 ng·hr/mL to about 70 ng·hr/mL.
9. The method of claim 8 , wherein the composition has a pH of about 4.2 to 5.3.
10. The method of claim 8 , wherein the patient is suffering from acute migraine.
11. The method of claim 10 , wherein the patient is suffering from acute migraine with aura.
12. The method of claim 10 , wherein the patient is suffering from acute migraine without aura.
13. The method of claim 8 , wherein the method comprises injecting the composition using an autoinjector.
14. The method of claim 13 , wherein the autoinjector comprises a 0.5 mL prefilled, ready-to-use, single dose, disposable auto-injector.
15. The method of claim 8 , wherein the maximum recommended frequency of administration is not more than four times a day.