IP Library Patent Application 17273811
Patent Application
App. No. 17/273,811

METHODS OF TREATING MIGRAINE

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Patent No.
US None
App. No.
17/273,811
Abstract

The present application relates to a method of reducing a need of rescue medication and/or a need of more than one dose of migraine medication in a patient suffering from cephalic pain, including migraine, cluster headache, episodic migraine, or rapid escalating migraine. In some embodiments, the method includes administering intranasally a composition comprising sumatriptan, or a physiologically-acceptable salt or a solvate thereof, and an alkyl glycoside or a saccharide alkyl ester.

Claims (25)

1 . A method of treating cephalic pain, comprising:

selecting a patient suffering from or susceptible to cephalic pain, who is identified as being susceptible to a need for rescue medication and/or more than one dose of abortive medication following onset of the cephalic pain; and

administering intranasally a composition comprising sumatriptan, or a physiologically-acceptable salt or a solvate thereof, and an alkyl glycoside or a saccharide alkyl ester.

2 . The method of claim 1 , wherein said composition further includes at least one pharmaceutically-acceptable excipient.

3 . The method of claim 1 , wherein said composition, upon intranasal administration to said patient, provides at least one of the following clinical endpoints:

(a) pain freedom in at least about 35% patient population at 2 hours post-dose;

(b) pain relief in at least about 70% patient population at 2 hours post-dose;

(c) sustained pain freedom in at least about 33% patient population from 2 to 24 hours post-dose; and

(d) freedom from functional disability in at least about 45% patient population at 2 hours post-dose.

4 . The method of claim 1 , wherein said composition comprises sumatriptan in an amount of about 2.5 mg to about 25 mg of sumatriptan base.

5 . The method of claim 1 , wherein said alkyl glycoside or saccharide alkyl ester is present in an amount of from about 0.05% to about 3.0%.

6 . The method of claim 5 , wherein said alkyl glycoside or saccharide alkyl ester is selected from the group consisting of: dodecyl maltoside (1-O-n-dodecyl-β-D-maltopyranoside), tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate, and sucrose monotetradecanoate.

7 . The method of claim 1 , wherein said salt of sumatriptan is selected from group consisting of: sulphate salt, citrate salt, phosphate salt, maleate salt, formate salt, and acetate salt.

8 . The method of claim 1 , wherein said composition, upon intranasal administration, provides absence of nausea in at least about 65% of patients at 2 hours post-dose.

9 . The method of claim 1 , wherein said composition, upon intranasal administration, provides an absence of photophobia in at least about 60% of patients at 2 hours post-dose.

10 . The method of claim 1 , wherein said composition, upon intranasal administration, provides an absence of phonophobia in at least about 65% patient population at 2 hours post-dose.

11 . The method of claim 1 , wherein said composition, upon intranasal administration, provides treatment satisfaction in at least about 60% of patients at 2 hours post-dose.

12 . The method of claim 1 , wherein said composition is in the form of a solution, suspension, emulsion, aerosol, or powder.

13 . The method of claim 1 , wherein the cephalic pain is migraine.

14 . The method of claim 13 , wherein the patient is susceptible to the need for rescue medication, and such need is reduced by at least about 50%.

15 . The method of claim 1 , wherein said rescue medication is selected from group comprising opioids, acetaminophen, aspirin, ibuprofen, rizatriptan, naratriptan, zolmitriptan, eletripan, almotriptan or dihydroergotamine.

16 . The method of claim 1 , wherein said composition provides a T max value less than or equal to about 30 minutes.

17 . The method of claim 1 , wherein said composition, upon intranasal administration, provides a T max substantially equivalent to that of a subcutaneous sumatriptan injection comprising 4 mg or 6 mg sumatriptan base.

18 . The method of claim 13 , wherein the patient is susceptible to the need for more than one dose of abortive medication, wherein the abortive medication is migraine medication, and wherein the need for a second dose of migraine medication is reduced by at least about 30%.

19 . The method of claim 1 , wherein the cephalic pain is migraine, cluster headache, episodic migraine, or rapid escalating migraine.

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 →
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE PREVIOUSLY RECORDED AT REEL: 055683 FRAME: 0056. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Mar 30, 2021
From: DR. REDDY'S LABORATORIES LTD.
To: UPSHER-SMITH LABORATORIES, LLC
Reel/Frame 055982/0780 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 23, 2021
From: MUNJAL, SAGAR; JANA, ARUN
To: DR. REDDY'S LABORATORIES LTD.
Reel/Frame 055682/0987 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 23, 2021
From: DR. REDDY'S LABORATORIES LTD.
To: UPSHER-SMITH LABORATIES, LLC
Reel/Frame 055683/0056 →