Methods and compositions for treating and preventing mucositis

• US 6,713,463 B2
• Filed: 09/27/2002
• Issued: 03/30/2004
• Est. Priority Date: 03/13/1998
• Status: Expired due to Fees

• Current Assignee: Mucosal Therapeutics, LLC
• Original Assignee: Mucosal Therapeutics, LLC
• Inventors: Sonis, Stephen T., Fey, Edward G.
• Primary Examiner(s): Reamer, James H
• Application Number:
  US10/260,093
• Publication Number:
  US 20030036560A1
• Time in Patent Office: 550 Days
• Field of Search: 514/623, 514/258, 514/152, 514/204, 514/520, 514/682, 514/226.5
• US Class Current: 514/152
• 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 31/195 having an amino group
• CPC Class Codes: A61K 31/235 having an aromatic ring attached to a carboxyl group
• 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 31/65 Tetracyclines
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A method of reducing or inhibiting mucositis in a patient, which includes administering an inflammatory cytokine inhibitor or a mast cell inhibitor, or a combination thereof, is disclosed.

Claims

1. A pharmaceutical composition for treating oral mucositis comprising

(a) a first therapeutic agent comprising an NSAID, an inflammatory cytokine inhibitor, or a mast cell inhibitor;

(b) a second, different therapeutic agent comprising an inflammatory cytokine inhibitor, a mast cell inhibitor, an MMP inhibitor, an NSAID, or an NO inhibitor; and

(c) a pharmaceutically acceptable carrier, wherein said first and second therapeutic agents are present in amounts sufficient to inhibit mucositis in a patient suffering from mucositis or at risk for mucositis due to chemotherapy or radiation.

2. The pharmaceutical composition of claim 1, wherein said composition is formulated into a lozenge, a table, an oral rinse, an oral paste, or an oral gel.

3. The pharmaceutical composition of claim 1, wherein said mast cell inhibitor is an antihistamine.

4. The pharmaceutical composition of claim 1, wherein said anti-inflammatory agent is an NSAID.

5. The pharmaceutical composition of claim 4, wherein said composition further comprises an anti-ulcer agent in an amount sufficient to inhibit gastric mucosal injury.

6. The pharmaceutical composition of claim 1, wherein said inflammatory cytokine inhibitor is a cyclooxygenase-2 inhibitor.

7. The pharmaceutical composition of claim 1, wherein said composition further comprises an antimicrobial agent in an amount sufficient to inhibit infection.