Claims for Patent: 12,194,008

Summary for Patent: 12,194,008

Title:	Nasal formulations of metoclopramide
Abstract:	Nasal formulations of metoclopramide, which remain stable and/or colorless upon storage over a period of time, are provided. Also provided are methods of treating disorders treatable with metoclopramide, comprising administering the nasal solutions to patients in need thereof.
Inventor(s):	Matthew J. D'Onofrio, David A. Gonyer, Shirish A. Shah, Stuart J. Madden
Assignee:	Evoke Pharma Inc
Application Number:	US17/366,818
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,194,008
Patent Claims:	1. A method of treating gastroparesis in a patient, comprising intranasally administering to the patient an amount of a metoclopramide composition effective to deliver a daily dose of about 30 mg to about 60 mg of metoclopramide, or a pharmaceutically-acceptable salt thereof, wherein the metoclopramide composition comprises citrate in a concentration of at least about 10 millimolar, and wherein the intranasally administering is effective to treat gastroparesis. 2. The method of claim 1, wherein the intranasal administration comprises an intranasal spray. 3. The method of claim 2, wherein the intranasal spray is administered as one, two, three, or four intranasal sprays per day. 4. The method of claim 1, wherein the metoclopramide composition further comprises benzalkonium chloride. 5. The method of claim 4, wherein the benzalkonium chloride is present in the metoclopramide composition at a concentration of from about 0.005% (w/v) to about 0.05% (w/v). 6. The method of claim 1, wherein the metoclopramide composition has a pH of above about 4.5. 7. The method of claim 1, wherein the metoclopramide composition has an osmolality of from about 500 mOsm/kg to about 1400 mOsm/kg. 8. The method of claim 1, wherein the metoclopramide composition further comprises a buffer selected from the group consisting of citric acid/phosphate, acetate, barbital, borate, Britton-Robinson, cacodylate, citrate, collidine, formate, maleate, McIlvaine, phosphate, Prideaux-Ward, succinate, citrate-phosphate-borate (Teorell-Stanhagen), veronal acetate, IVIES (2-(N-morpholino)ethanesulfonic acid), BIS-TRIS (bis(2-hydroxyethyl)iminotris(hydroxymethyl)methane), ADA (N-(2-acetamido)-2-iminodiacetic acid), ACES (N-(carbamoylmethyl)-2-aminoethanesulfonaic acid), PIPES (piperazine-N,N′-bis(2-ethanesulfonic acid)), MOPSO (3-(N-morpholino)-2-hydroxypropanesulfonic acid), BIS-TRIS PROPANE (1,3-bis(tris(hydroxymethyl)methylamino)propane), BES (N,N-bis(2-hydroxyethyl)-2-aminoethanesulfonaic acid), MOPS (3-(N-morpholino)propanesulfonic acid), TES (N-tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid), HEPES (N-(2-hydroxyethyl)piperazine-N′-(2-ethanesulfonic acid), DIPSO (3-(N,N-bis(2-hydroxyethyl)amino)-2-hydroxypropanesulfonic acid), MOBS (4-(N-morpholino)butanesulfonic acid), TAPSO (3-(N-tris(hydroxymethyl)methylamino)-2-hydroxy-propanesulfonic acid), tris(hydroxymethylaminomethane, HEPPSO(N-(2-hydroxyethyl)piperazine-N′-(2-hydroxypropanesulfonic acid), POPSO (piperazine-N,N′-bis(2-hydroxypropanesulfonic acid)), TEA (triethanolamine), EPPS(N-(2-hydroxyethyl)piperazine-N′-(3-propane-sulfonic acid), TWINE (N-tris(hydroxymethyl)methylglycine), GLY-GLY (glycylglycine), BICINE (N,N-bis(2-hydroxyethyl)glycine), HEPBS (N-(2-hydroxyethyl)piperazine-N′-(4-butanesulfonic acid)), TAPS(N-tris(hydroxy-methypmethyl-3-aminopropanesulfonic acid), and AMPD (2-amino-2-methyl-1,3-propanediol) buffer. 9. The method of claim 8, wherein the buffer comprises sodium citrate. 10. The method of claim 1, wherein the patient has a symptom that is treatable with metoclopramide. 11. The method of claim 10, wherein the symptom that is treatable with metoclopramide is selected from the group consisting of emesis, delayed emesis, and nausea. 12. The method of claim 1, wherein the metoclopramide composition further comprises at least one of EDTA and sorbitol. 13. The method of claim 1, wherein the patient is human. 14. The method of claim 1, wherein the metoclopramide composition is substantially free of any additional antioxidant. 15. The method of claim 1, wherein the daily dose is about 30 mg. 16. The method of claim 1, wherein the daily dose is about 45 mg. 17. The method of claim 1, wherein the daily dose is about 60 mg.