Claims for Patent: 10,537,554

Summary for Patent: 10,537,554

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:	15/011,357
Patent Claims:	1. A method of treating acute migraine in a patient in need thereof, said method comprising: subcutaneously administering by a single-use, ready to use, disposable, auto-injector to the patient a composition comprising an aqueous solution of sumatriptan succinate in an amount of 4.2 mg, and sodium chloride in an amount of 4.2 mg contained in a 0.5 mL pre-filled syringe (PFS) fully assembled into the auto-injector; wherein said composition has osmolality between 275 to 315 mOsm/kg; wherein said composition has a pH of about 4.2 to 5.3; wherein the patient is suffering from acute migraine and the composition is not administered for prophylactic treatment of migraine or treatment of cluster headache. 2. The method of claim 1, wherein the subcutaneous administration of said composition to the patient results in a systemic exposure characterized by at least one of the following plasma profiles: a. C.sub.max of about 35 ng/ml to about 57 ng/ml; b. AUC.sub.0-2 of about 30 nghr/ml to about 50 nghr/ml; and/or c. AUC.sub.0-inf of about 43 nghr/ml to about 70 nghr/ml. 3. The method of claim 1, wherein the subcutaneous administration of said composition to the patient provides a reduction in injection site pain as compared to subcutaneous administration of a composition comprising an injectable solution of sumatriptan succinate in an amount of 4.2 mg sumatriptan succinate contained in 0.25 ml. 4. The method of claim 1, wherein the subcutaneous administration of said composition to the patient provides a reduction in injection site pain as compared to subcutaneous administration of a composition comprising 5.6 mg sumatriptan succinate contained in 0.5 mL. 5. The method of claim 1, wherein the subcutaneous administration of said composition to the patient provides a reduction in injection site pain as compared to subcutaneous administration of a composition comprising 8.4 mg sumatriptan succinate contained in 0.5 mL.