US-20260124175-A1 - METHODS OF TREATING PAIN

Abstract

The present application relates to a method of providing a therapeutic regimen for the treatment of pain, wherein said method comprises administering an oral liquid pharmaceutical composition comprising celecoxib or a pharmaceutically acceptable salt thereof to a subject in need thereof.

Inventors

• Sagar MUNJAL
• Anirudh GAUTAM

Assignees

• SCILEX HOLDING COMPANY

Dates

Publication Date

20260507

Application Date

20250611

Claims (2)

1. 1 - 20 . (canceled)
2. 21 . A method of treating, ameliorating, or reducing an acute odontogenic pain condition comprising administering an oral liquid pharmaceutical composition comprising celecoxib or a pharmaceutically acceptable salt thereof to a subject in need thereof, wherein said method provides at least one of the following summed pain intensity difference (SPID) scores: a. at 2 hours post-dose of at least about 250; b. at 6 hours post-dose of at least about 1000; and c. at 8 hours post-dose of at least about 1400.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 18/935,972, filed Nov. 4, 2024, which is a continuation of U.S. patent application Ser. No. 17/562,229, filed Dec. 27, 2021, now issued as U.S. Pat. No. 12,168,000, which claims the benefit of and priority to U.S. Provisional Patent Application No. 63/131,172, filed Dec. 28, 2020, the contents of each of which are incorporated by reference herein in their entirety. FIELD OF THE APPLICATION The present application relates to a method of providing a therapeutic regimen for the treatment of acute pain, wherein said method comprises administering an oral liquid pharmaceutical composition comprising celecoxib or a pharmaceutically acceptable salt thereof to a subject in need thereof. BACKGROUND Celecoxib is a non-steroidal anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor, generally used for the treatment of pain. Chemically celecoxib is designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows: Celecoxib was described in U.S. Pat. No. 5,466,823 assigned to Searle, which is directed to a class of 1, 5-diaryl pyrazoles and their salts, together with processes for the preparation of such compounds. Celecoxib is approved in the U.S. under the brand name CELEBREX®, as oral capsules and used in the treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain, chronic pain, primary dysmenorrhea, and familial adenomatous polyposis. It is available in the strengths of 50 mg, 100 mg, 200 mg, and 400 mg. Celecoxib is a hydrophobic and highly permeable drug belonging to class II of the biopharmaceutics classification system. The insoluble nature of celecoxib leads to high variability in absorption and hence has limited bioavailability after oral administration. Celecoxib has an aqueous solubility of about 5 μg/ml at between 5° C. and 40° C., which is pH-independent at pH <9. Celecoxib is not readily dissolved and dispersed for rapid absorption in the gastrointestinal tract when administered orally, for example, in capsule form. Oral administration is always associated with a delayed onset for getting the desired pharmacological action. It is known that upon oral administration, celecoxib takes approximately 3.0 hours for peak plasma concentrations and hence has a delayed onset of action after administration. Additionally, the intake of food further influences drug absorption. Also, correct dosing is an added complexity that further affects therapeutically effective plasma drug concentration, wherein safety and efficacy must be balanced upon administration. Additionally, it is always desired to achieve therapeutic serum levels fast enough to receive benefits for acute conditions. However, acute pain conditions like odontogenic pain, including post-surgical dental pain, dental pulpitis (toothache), and/or tooth sensitivity, demand immediate/faster pain relief with maintained serum concentration of the drug for time. There remains a clear unmet need in the art for the treatment of acute pain conditions, to provide a suitable therapeutic regimen for celecoxib with faster pain relief, and with minimal or reduced adverse events. Accordingly, the present application relates to a method of providing a therapeutic regimen for the treatment of acute pain, wherein said method comprises administering an oral liquid pharmaceutical composition comprising celecoxib or a pharmaceutically acceptable salt thereof to a subject in need thereof. SUMMARY In one embodiment, the present application provides a method of providing a therapeutic regimen for the treatment of pain, wherein said method comprises administering an oral liquid pharmaceutical composition comprising celecoxib or a pharmaceutically acceptable salt thereof, to a subject in need thereof. In another embodiment, the present application provides a method of treating or ameliorating or reducing acute pain condition comprising administering an oral liquid pharmaceutical composition comprising celecoxib or a pharmaceutically acceptable salt thereof, to a subject in need thereof, wherein said method offers significantly similar or lesser incidence of treatment-emergent adverse events compared to placebo therapy. In an aspect of the above embodiments, the oral liquid pharmaceutical composition comprising celecoxib is administered with or without food. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows pain intensity difference (PID) scores over time for example-1, example-2, and example-3 over CELEBREX® 200 mg and CELEBREX® 400 mg oral capsules. FIG. 2A shows a summary of the pharmacodynamic (PD) metrics for a proposed initial dose of 175 mg of celecoxib on day 1, followed by subsequent doses of 125 mg of celecoxib after every 8 ho