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.
an aqueous solution of sumatriptan or its pharmaceutically acceptable salts thereof in an amount equivalent to 3 mg of sumatriptan base, and sodium chloride in an amount to maintain the osmolality of said solution between 275 to 315 mOsm/kg;
wherein said sumatriptan and sodium chloride are present in a ratio of from about 0.80:1.00 to about 1.40:1.00;
wherein said composition has a pH of about 4.2 to 5.3;
wherein said composition is subcutaneoosly administered to the patient at a maximum recommended frequency according to the body mass index (BMI) of the patient; and
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:
c. Cma* of about 35 ng/ml to about 57 ng/ml;
d. AUCo-2 of about 30 ng.hr/ml to about 50 ng.hr/ml;
a. AUQ).jnf of about 43 ng.hr/ml to about 70 ng.hr/ml.
29. The composition of Claim 28, wherein the maximum recommended frequency of administration is not more than four times a day if the BMI is less than about 26.
30. The composition of Claim 28, wherein the maximum recommended frequency of administration is not more than four times a day if the BMI is greater than or equal to about 26.
| # | Name | Date |
|---|---|---|
| 1 | 201847004353-STATEMENT OF UNDERTAKING (FORM 3) [05-02-2018(online)].pdf | 2018-02-05 |
| 2 | 201847004353-POWER OF AUTHORITY [05-02-2018(online)].pdf | 2018-02-05 |
| 3 | 201847004353-FORM 1 [05-02-2018(online)].pdf | 2018-02-05 |
| 4 | 201847004353-DECLARATION OF INVENTORSHIP (FORM 5) [05-02-2018(online)].pdf | 2018-02-05 |
| 5 | 201847004353-COMPLETE SPECIFICATION [05-02-2018(online)].pdf | 2018-02-05 |
| 6 | 201847004353-FORM 3 [30-05-2018(online)].pdf | 2018-05-30 |
| 7 | 201847004353-RELEVANT DOCUMENTS [24-10-2018(online)].pdf | 2018-10-24 |
| 8 | 201847004353-PETITION UNDER RULE 137 [24-10-2018(online)].pdf | 2018-10-24 |
| 9 | Correspondence by Agent_Form 1, Petition Under Rule_29-10-2018.pdf | 2018-10-29 |
| 10 | 201847004353-FORM 3 [20-03-2019(online)].pdf | 2019-03-20 |
| 11 | 201847004353-FORM 13 [20-03-2019(online)].pdf | 2019-03-20 |
| 12 | 201847004353-FORM 18 [26-03-2019(online)].pdf | 2019-03-26 |
| 13 | 201847004353-FER.pdf | 2019-11-27 |
| 14 | 201847004353-FORM 3 [16-03-2020(online)].pdf | 2020-03-16 |
| 15 | 201847004353-FER_SER_REPLY [26-05-2020(online)].pdf | 2020-05-26 |
| 16 | 201847004353-COMPLETE SPECIFICATION [26-05-2020(online)].pdf | 2020-05-26 |
| 17 | 201847004353-CLAIMS [26-05-2020(online)].pdf | 2020-05-26 |
| 18 | 201847004353-ABSTRACT [26-05-2020(online)].pdf | 2020-05-26 |
| 19 | 201847004353-US(14)-HearingNotice-(HearingDate-07-10-2022).pdf | 2022-09-07 |
| 1 | ss_14-11-2019.pdf |