IP Library Granted Patent US 7,378,434
Granted Patent B2
US 7,378,434 · App. 11/483,332 · Granted May 27, 2008

Metaxalone products, method of manufacture, and method of use

Assignee: Mutual Pharmaceutical Company, Inc.
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Quick Facts
Patent No.
US 7,378,434
App. No.
11/483,332
Granted
May 27, 2008
Kind
B2
Abstract

Disclosed herein is a method of using metaxalone. In one embodiment, the method comprises obtaining metaxalone from a container providing information that metaxalone affects the activity of a cytochrome p450 isozyme. In another embodiment, the method comprises informing a user that metaxalone affects the activity of a cytochrome p450 isozyme. Also included are articles of manufacture comprising a container containing a dosage form of metaxalone, wherein the container is associated with published material informing that metaxalone affects activity of a cytochrome p450 isozyme. Also disclosed are a method of treatment and a method of manufacturing a metaxalone product.

Claims (16)

1. A method of using metaxalone for treating a musculoskeletal condition, comprising

administering to a human patient metaxalone and an inhibitor or an inducer of CYP1A2;

informing the human patient that metaxalone is a substrate of CYP1A2 and that administration of metaxalone and an inhibitor or an inducer of CYP1A2 can affect plasma concentration, bioavailability, safety, efficacy, or a combination comprising at least one of the foregoing of metaxalone; and

monitoring the human patient's plasma concentration of metaxalone while metaxalone and the inhibitor or the inducer of CYP1A2 are administered to the human patient.

2. The method of claim 1 , additionally comprising

altering dosing of metaxalone based on the human patient's plasma concentration of metaxalone.

3. The method of claim 1 , wherein an inhibitor of CYP1A2 is administered to the human patient and the inhibitor of CYP1A2 is amiodarone, cimetidine, a fluoroquinolone, fluvoxamine, furafylline, interferon, methoxsalen, or mibefradil.

4. The method of claim 1 , wherein an inducer of CYP1A2 is administered to the human patient and the inducer of CYP1A2 is insulin, methyl cholanthrene, modafinil, nafcillin, beta-naphthoflavone, or omeprazole.

5. A method of using metaxalone for treating a musculoskeletal condition, comprising

administering to a human patient metaxalone and an inhibitor or an inducer of CYP2C19;

informing the human patient that metaxalone is a substrate of CYP2C19 and that administration of metaxalone and an inhibitor or an inducer of CYP2C19 can affect plasma concentration, bioavailability, safety, efficacy, or a combination comprising at least one of the foregoing of metaxalone; and

monitoring the human patient's plasma concentration of metaxalone while metaxalone and the inhibitor or the inducer of CYP2C19 are administered to the human patient.

6. The method of claim 5 , additionally comprising

altering dosing of metaxalone based on the human patient's plasma concentration of metaxalone.

7. The method of claim 5 , wherein an inhibitor of CYP2C19 is administered to the human patient and the inhibitor of CYP2C19 is chloramphenicol, cimetidine, felbamate, fluoxetine, fluvoxamine, indomethacin, ketoconazole, lansoprazole, modafinil, omeprazole, oxcarbazepine, probenicid, ticlopidine, or topiramate.

8. The method of claim 5 , wherein an inducer of CYP2C19 is administered to the human patient and the inducer of CYP2Cl9 is carbamazepine, norethindrone, prednisone, or rifampicin.

Assignments (7)
MERGER Recorded Nov 30, 2012
From: PHARMACEUTICAL IP HOLDING, INC.
To: MPC OLDCO, INC.
Reel/Frame 029381/0117 →
MERGER Recorded Nov 30, 2012
From: MPC OLDCO, INC.
To: MPC MERGER SUB, INC.
Reel/Frame 029381/0439 →
MERGER Recorded Nov 30, 2012
From: MPC MERGER SUB, INC.
To: TAKEDA PHARMACEUTICALS U.S.A., INC.
Reel/Frame 029381/0477 →
RELEASE OF SECURITY INTEREST Recorded Aug 12, 2011
From: UBS AG, STAMFORD BRANCH, A SWISS BANKING INSTITUTION
To: MUTUAL PHARMACEUTICAL COMPANY, INC., A PENNSYLVANIA CORPORATION
Reel/Frame 026744/0541 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 26, 2009
From: MUTUAL PHARMACEUTICAL COMPANY, INC.
To: PHARMACEUTICAL IP HOLDING, INC.
Reel/Frame 022315/0313 →
PATENT SECURITY AGREEMENT Recorded Jan 30, 2007
From: MUTUAL PHARMACEUTICAL COMPANY, INC.
To: UBS AG, STAMFORD BRANCH, AS COLLATERAL AGENT
Reel/Frame 018826/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 10, 2006
From: DU, JIE; ROBERTS, RICHARD H.
To: MUTUAL PHARMACEUTICAL COMPANY, INC.
Reel/Frame 018097/0052 →
Continuity (4)
Continuation 1136446800 · Feb 28, 2006
Continuation 1134953400 · Feb 6, 2006
Provisional Application 6072686100 · Oct 14, 2005
Related Publication 20070088066A1 · Apr 19, 2007