IP Library Granted Patent US 10,537,554
Granted Patent B2
US 10,537,554 · App. 15/011,357 · Granted Jan 21, 2020

Pharmaceutical composition for treating migraine

Inventors: Prabhu Prabhakara (Udupi, IN); Rajesh Ramesh Patil (Thane, IN); Piyush Gupta (Ghaziabad, IN); Rajeev Singh Raghuvanshi (Gurgaon, IN); Anil N. Namboodiripad (Yardley, PA)
Assignee: UPSHER-SMITH LABORATORIES, LLC
A61K31/4045A61K9/0019A61K9/08
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Quick Facts
Patent No.
US 10,537,554
App. No.
15/011,357
Granted
Jan 21, 2020
Kind
B2
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.

Claims (12)

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 max of about 35 ng/ml to about 57 ng/ml;

b. AUC 0-2 of about 30 ng·hr/ml to about 50 ng·hr/ml; and/or

c. AUC 0-inf of about 43 ng·hr/ml to about 70 ng·hr/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.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 3, 2024
From: TONIX PHARMA LIMITED
To: TONIX MEDICINES, INC.
Reel/Frame 066989/0383 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 9, 2024
From: UPSHER-SMITH LABORATORIES, LLC
To: TONIX MEDICINES, INC.
Reel/Frame 066429/0436 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 9, 2024
From: TONIX MEDICINES, INC.
To: TONIX PHARMA LIMITED
Reel/Frame 066429/0445 →
ASSET PURCHASE Recorded Jul 26, 2019
From: PROMIUS PHARMA, LLC
To: UPSHER-SMITH LABORATORIES, LLC
Reel/Frame 049878/0272 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 14, 2018
From: DR. REDDY'S LABORATORIES LTD.
To: PROMIUS PHARMA LLC
Reel/Frame 047774/0515 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 7, 2018
From: PRABHAKARA, PRABHU; PATIL, RAJESH RAMESH; GUPTA, PIYUSH; RAGHUVANSHI, RAJEEV SINGH; NAMBOODIRIPAD, ANIL N.
To: DR. REDDY'S LABORATORIES LTD.
Reel/Frame 045128/0832 →
Priority Claims (1)
IN 4076/CHE/2015 · Aug 5, 2015 · national
Continuity (1)
Related Publication 20170035729A1 · Feb 9, 2017
Cited By (1)
US 12,673,040