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 delivery system comprising:
a delivery device; and
a pharmaceutical composition formulated for subcutaneous administration comprising an aqueous solution, wherein the aqueous solution comprises 4.2 mg sumatriptan succinate and 4.15 mg to 4.2 mg sodium chloride in a total volume of 0.5 mL, and optionally at least one pharmaceutically acceptable excipient, and
wherein the aqueous solution has osmolality between 275 to 315 mOsm/kg.
2 . The delivery system of claim 1 , wherein the aqueous solution has a pH of about 4.2 to 5.3.
3 . The delivery system of claim 1 , wherein the delivery device comprises a device for autoinjection.
4 . The delivery system of claim 3 , wherein the device for autoinjection comprises a pre-filled syringe disposed within the device for autoinjection.
5 . The delivery system of claim 3 , wherein the device for autoinjection is a single-use, ready-to-use, disposable device for autoinjection.
6 . The delivery system of claim 4 , wherein the pre-filled syringe contains 0.5 mL of the aqueous solution of claim 1 , wherein the aqueous solution comprises 4.2 mg sumatriptan succinate and 4.15 mg to 4.2 mg sodium chloride, and wherein the aqueous solution has osmolality between 275 to 315 mOsm/kg.
7 . The delivery system of claim 4 , wherein the pre-filled syringe comprises a permeable part for sterilization with ethylene oxide.
8 . The delivery system of claim 1 , wherein administration of the pharmaceutical composition to a subject results in a systemic exposure in the subject characterized by one or more of a plasma profile selected from:
(i) C max of about 35 ng/ml to about 57 ng/ml;
(ii) AUC 0-2 of about 30 ng·hr/mL to about 50 ng·hr/mL; and
(iii) AUC 0-inf of about 43 ng·hr/mL to about 70 ng·hr/mL.