Acute Treatment of Headache with Phenothiazine Antipsychotics
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.
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 antipsychotic is a phenothiazine antipsychotic.
17 . The method of claim 16 , wherein the phenothiazine antipsychotic is selected from prochlorperazine, trifluoperazine, fluphenazine, promethazine, perphenazine, chlorpromazine, thioridazine, mesoridazine, and acetophenazine.
18 . The method of claim 17 , wherein the phenothiazine antipsychotic is about 1 mg to 18 mg prochlorperazine.
19 . The method of claim 17 , wherein the phenothiazine antipsychotic is about 1 mg to 9 mg prochlorperazine.
20 . The method of claim 17 , wherein the phenothiazine antipsychotic is about 1 mg to 5 mg prochlorperazine.
21 . The method of claim 1 , wherein the patient self-administers one or more doses of the antipsychotic.
22 . The method of claim 21 , 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.
23 . The method of claim 221 , 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.
24 . A method of treating a headache, comprising administering by inhalation about 1 mg to 18 mg prochlorperazine to a patient in need of headache relief, wherein the prochlorperazine is administered such that the peak plasma concentration of the prochlorperazine is obtained within 15 minutes of initiation of administration of the prochlorperazine and wherein a decrease in headache severity is obtained within 2 hours of prochlorperazine administration.
25 . The method of claim 24 , wherein the decrease in headache severity persists for at least 12 hours.
26 . The method of claim 24 , wherein the headache is at least one of a migraine headache, a tension-type headache, or a cluster headache.
27 . 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.
28 . The method of claim 27 , wherein the antipsychotic is prochlorperazine.
29 . The method of claim 28 , wherein less than 6 mg of prochlorperazine is administered.
30 . The method of claim 29 , wherein the administration is via inhalation.
31 . The method of claim 30 , wherein the inhalation is of a condensation aerosol comprising the prochlorperazine.