PRAMIPEXOLE TRANSDERMAL DELIVERY FOR SEVERE HEADACHES

• US 20140045801A1
• Filed: 08/09/2012
• Published: 02/13/2014
• Est. Priority Date: 08/09/2012
• Status: Abandoned Application

• Current Assignee: Mylan Incorporated (Pfizer Inc.)
• Original Assignee: Mylan Incorporated (Pfizer Inc.)
• Inventors: Rossi, David Thomas
• Application Number:
  US13/570,593
• Publication Number:
  US 20140045801A1
• Time in Patent Office: Days
• US Class Current: 514/171
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/138 Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/195 having an amino group
• CPC Class Codes: A61K 31/277 having a ring, e.g. verapamil
• CPC Class Codes: A61K 31/4015 having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
• CPC Class Codes: A61K 31/403 condensed with carbocyclic rings, e.g. carbazole
• CPC Class Codes: A61K 31/404 Indoles, e.g. pindolol
• CPC Class Codes: A61K 31/4045 Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
• CPC Class Codes: A61K 31/405 Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
• CPC Class Codes: A61K 31/4196 1,2,4-Triazoles
• CPC Class Codes: A61K 31/422 not condensed and containing further heterocyclic rings
• CPC Class Codes: A61K 31/428 condensed with carbocyclic rings
• CPC Class Codes: A61K 31/4422 1,4-Dihydropyridines, e.g. nifedipine, nicardipine
• CPC Class Codes: A61K 31/454 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
• CPC Class Codes: A61K 31/48 Ergoline derivatives, e.g. lysergic acid, ergotamine
• CPC Class Codes: A61K 31/485 : Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/616 : by carboxylic acids, e.g. acetylsalicylic acid
• CPC Class Codes: A61K 31/7048 : having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin , digitoxin or digoxin
• CPC Class Codes: A61K 45/06 : Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/7023 : Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61P 25/04 : Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/06 : Antimigraine agents
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention relates to a method for the treatment and prevention of cluster headaches and migraines using the transdermal administration of pramipexole.

Claims

1. A method of treating and preventing cluster headaches and migraines in a human patient, comprising administering pramipexole transdermally to said human patient.

2. The method of claim 1, wherein the transdermal delivery is in the form of a patch.

3. The method of claim 2, wherein the transdermal patch is a form selected from the group consisting of a single layer drug in adhesive, a multi-layer drug in adhesive, a reservoir patch, a monolithic patch, and a vapor patch.

4. The method of claim 1 wherein the cluster headaches and migraines are reoccurring or chronic.

5. The method of any one of claims 1-4, wherein the pramipexole is delivered in doses of from 0.01 mg to 10 mg per day for 1 to 7 days.

6. The method of claim 5, wherein the rate of administration of drug to patient ranges from 1 μ

g to 200 μ

g per hour.

7. The method of any one of claims 1-6, wherein the pramipexole is delivered in its free base form.

8. The method of any one of claims 1-7, further comprising an additional drug useful for treating or preventing headaches.

9. The method of claim 8, wherein the additional drug is selected from the group consisting of a serotonin receptor agonist, an NSAID, an antidepressant, an ergotalkaloid, an opioid, an antiepileptic, an anti-seizure drug, a calcium channel blacker, and a beta blocker.

10. The method of claim 9, wherein the serotonin receptor agonist is selected from the group consisting of sumatriptan, elitriptan, frovotriptan, zolmitriptan, naratriptan, rizatriptan, or almotriptan.

11. The method of claim 9, wherein the NSAID is selected from the group consisting of ibuprofen, naproxen, aspirin, acetaminophen, indomethacin, and ketoprofin.

12. The method of claim 9, wherein the antidepressant is amitriptyline.

13. The method of claim 9, wherein the ergotalkaloid is ergotamine.

14. The method of claim 9, wherein the opioid is selected from the group consisting of oxycodone and hydrocodone.

15. The method of claim 9, wherein the antiepileptic is selected from the group consisting of gabapentin, topiramate, and levetiracetam.

16. The method of claim 9, wherein the anti-seizure drug sodium valerate.

17. The method of claim 9, wherein the calcium channel blocker is selected from the group consisting of verapamil and amlodipine.

18. The method of claim 9, wherein the beta blocker is selected from the group consisting of propanolol, metoprolol, carvedilol, and atenolol.