IP Library Patent Application 14721896
Patent Application
App. No. 14/721,896

ACUTE TREATMENT OF HEADACHE WITH PHENOTHIAZINE ANTIPSYCHOTICS

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Quick Facts
Patent No.
US None
App. No.
14/721,896
Abstract

Methods of treating headache with antipsychotics are provided. A kit for treating headache is also provided, comprising an antipsychotic and a device for rapid delivery of the antipsychotic.

Claims (20)

1 . A method of treating a headache comprising administering by inhalation a composition comprising an antipsychotic to a patient in need of headache relief.

2 . The method of claim 1 , wherein the peak plasma concentration of the antipsychotic in the patient is obtained within 15 minutes of initiation of inhalation.

3 . The method of claim 1 , wherein a therapeutic systemic concentration of the antipsychotic in the patient is obtained within 15 minutes of initiation of inhalation.

4 . The method of claim 1 , wherein the concentration of antipsychotic in the plasma of the patient is at least 30 percent of the peak plasma concentration within 2 minutes of initiation of inhalation.

5 . The method of claim 1 , wherein headache relief is statistically significant compared to baseline at a time point 15 minutes or less following initiation of inhalation.

6 . The method of claim 1 , wherein headache relief is statistically significant compared to baseline at a time point 2 hours or less following initiation of inhalation and at a time point 12 hours or more following initiation of inhalation.

7 . The method of claim 1 , wherein headache severity is decreased at a time point 5 minutes or less following initiation of inhalation.

8 . The method of claim 1 , wherein headache severity is decreased at a time point 15 minutes or less following initiation of inhalation.

9 . The method of claim 1 , wherein headache severity is decreased at a time point 30 minutes or less following initiation of inhalation and at a time point 4 hours or more following initiation of inhalation.

10 . The method of claim 1 , wherein headache severity is decreased at a time point 2 hours or less following initiation of inhalation and at a time point 12 hours or more following initiation of inhalation.

11 . The method of claim 1 , wherein the patient is headache free at a time point 15 minutes or less following initiation of inhalation.

12 . The method of claim 1 , wherein the patient is headache free at a time point 2 hours or less following initiation of inhalation and at a time point 12 hours or more following inhalation.

13 . The method of claim 1 , wherein the mass median aerodynamic diameter of the inhaled composition is about 1 micron to 3 microns.

14 . The method of claim 1 , wherein the antipsychotic is a non-phenothiazine antipsychotic.

15 . The method of claim 1 , wherein the non-phenothiazine antipsychotic is selected from haloperidol, droperidol, chlorprothixene, thiothixene, loxapine, molindone, pimozide, flupenthixol, zuclopenthixol, and melperone.

16 . The method of claim 1 , wherein the patient self-administers one or more doses of the antipsychotic.

17 . The method of claim 16 , wherein the patient self-administers a first dose of the antipsychotic, assesses relief after a given interval of time, and, if sufficient headache relief is not obtained, self-administers one or more additional doses.

18 . The method of claim 17 , wherein the first dose is about 1 mg to 18 mg of the antipsychotic, and wherein the one or more additional doses is about 1 mg to 18 mg of the antipsychotic.

19 . A method of treating a migraine headache, comprising administering less than 9 mg of an antipsychotic to a patient in need of headache relief, wherein the peak plasma concentration of the antipsychotic is obtained within 15 minutes of initiation of administration of the antipsychotic, wherein a decrease in headache severity is obtained within 1 hour of initiation of administration of the antipsychotic, and wherein the decrease in headache severity persists for at least 12 hours after initiation of administration of the antipsychotic.

20 . The method of claim 29 , wherein the administration is via inhalation.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 15, 2015
From: HALE, RON L.; LLOYD, PETER M.; LU, AMY T.; MUNZAR, PATRIK; RABINOWITZ, JOSHUA D.; SKOWRONSKI, ROMAN
To: ALEXZA PHARMACEUTICALS, INC.
Reel/Frame 035910/0716 →