Claims for Patent: 12,097,183

Summary for Patent: 12,097,183

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):	Prabhu Prabhakara, Rajesh Ramesh Patil, Piyush Gupta, Rajeev Singh Raghuvanshi, Anil N. Namboodiripad
Assignee:	Tonix Medicines Inc
Application Number:	US17/833,105
Patent Claims:	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: Cmax of about 35 ng/mL to about 57 ng/mL; AUC0-2 of about 30 ng·hr/mL to about 50 ng·hr/mL; and AUC0-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.