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 pre-filled autoinjector for treating acute migraine in a patient by subcutaneous administration, the autoinjector 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 aqueous solution has osmolality between 275 to 315 mOsm/kg; and
wherein administration of the aqueous solution results in a systemic 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 pre-filled autoinjector of claim 1 further comprising a pre-filled syringe disposed within the autoinjector, wherein the aqueous solution is housed within the pre-filled syringe.
3. The pre-filled autoinjector of claim 2 , wherein the syringe contains 0.5 mL of the aqueous solution.
4. The pre-filled autoinjector of claim 2 , wherein the syringe comprises a permeable part for sterilization with ethylene oxide.
5. The pre-filled autoinjector of claim 1 , wherein the autoinjector is a single-use, ready-to-use, disposable autoinjector.
6. The pre-filled autoinjector of claim 1 , wherein aqueous solution has a pH of about 4.2 to 5.3.