Claims for Patent: 11,364,224

Summary for Patent: 11,364,224

Title:	Pharmaceutical composition for treating migraine
Abstract:	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.
Inventor(s):	Prabhakara; Prabhu (Udupi, IN), Patil; Rajesh Ramesh (Thane, IN), Gupta; Piyush (Ghaziabad, IN), Raghuvanshi; Rajeev Singh (Gurgaon, IN), Namboodiripad; Anil N. (Yardley, PA)
Assignee:	Upsher-Smith Laboratories, LLC (Maple Grove, MN)
Application Number:	16/718,414
Patent Claims:	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.sub.max of about 35 ng/mL to about 57 ng/mL; AUC.sub.0-2 of about 30 nghr/mL to about 50 nghr/mL; and AUC.sub.0-inf of about 43 nghr/mL to about 70 nghr/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.sub.max of about 35 ng/mL to about 57 ng/mL; AUC.sub.0-2 of about 30 nghr/mL to about 50 nghr/mL; and AUC.sub.0-inf of about 43 nghr/mL to about 70 nghr/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.