IP Library Granted Patent US 12,168,000
Granted Patent B2
US 12,168,000 · App. 17/562,229 · Granted Dec 17, 2024

Methods of treating pain

Inventors: Sagar Munjal (Raleigh, NC); Anirudh Gautam (Raleigh, NC)
Assignee: SCILEX HOLDING COMPANY
A61K31/415A61P29/00
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Quick Facts
Patent No.
US 12,168,000
App. No.
17/562,229
Granted
Dec 17, 2024
Kind
B2
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.

Claims (15)

1. 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, and said therapeutic regimen maintains steady-state maximum plasma concentration (C maxss ) of not more than about 1400 ng/mL upon oral administration under fasting conditions; wherein said therapeutic regimen comprises administering an initial dose of 200 mg of celecoxib on day 1, followed by subsequent doses of 100 mg of celecoxib after every 6 hours.

2. The method of claim 1 , wherein said therapeutic regimen comprises administering an initial dose of 200 mg of celecoxib on day 1, followed by subsequent doses of 100 mg of celecoxib after every 6 hours on day 1, and at least 100 mg of celecoxib after every 8 hours on subsequent days.

3. The method of claim 1 , wherein said therapeutic regimen comprises administering an oral liquid pharmaceutical composition comprising celecoxib or a pharmaceutically acceptable salt thereof, to a subject in need thereof, for at least two days.

4. 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, and said therapeutic regimen maintains steady-state maximum plasma concentration (C maxss ) of not more than about 1400 ng/ml upon oral administration under fasting conditions; wherein said therapeutic regimen comprises administering an initial dose of 200 mg of celecoxib on day 1, followed by subsequent doses of 100 mg of celecoxib after every 6 hours; wherein said steady-state maximum plasma concentration (C maxss ) of celecoxib is at least 2 fold higher than conventional 400 mg followed by 200 mg every 12 hours celecoxib oral capsules under fasting condition.

5. The method of claim 1 , wherein said therapeutic regimen provides at least 20% lesser T max compared to conventional 400 mg celecoxib oral capsules.

6. The method of claim 1 , wherein said therapeutic regimen provides pain intensity difference (PID) scores of less than 1.0 within about 30 minutes.

7. The method of claim 1 , wherein said therapeutic regimen is simulated using pharmacometric analysis.

8. The method of claim 1 , wherein the pain is acute odontogenic pain.

9. The method of claim 1 , wherein said oral liquid pharmaceutical composition is administered with food.

10. A method of treating or ameliorating or reducing an 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; wherein said treatment-emergent adverse events are selected from one or more of nausea, vomiting, increased blood bilirubin, dizziness, headache, epistaxis, and alveolar osteitis; and wherein said method comprises a therapeutic regimen comprising administering an initial dose of 200 mg of celecoxib on day 1, followed by subsequent doses of 100 mg of celecoxib after every 6 hours.

11. The method of claim 10 , wherein said therapeutic regimen comprises administering an initial dose of 200 mg of celecoxib on day 1, followed by subsequent doses of 100 mg of celecoxib after every 6 hours on day 1, and at least 100 mg of celecoxib after every 8 hours on subsequent days.

12. The method of claim 10 , wherein the acute pain condition is acute odontogenic pain.

13. The method of claim 10 , wherein said oral liquid pharmaceutical composition is administered with food.

14. The method of claim 1 , wherein said oral liquid pharmaceutical composition is administered without food.

15. The method of claim 10 , wherein said oral liquid pharmaceutical composition is administered without food.

Assignments (4)
SECURITY INTEREST Recorded Sep 21, 2023
From: SCILEX HOLDING COMPANY; SCILEX PHARMACEUTICALS INC.; SEMNUR PHARMACEUTICALS, INC.
To: ACQUIOM AGENCY SERVICES LLC, AS AGENT
Reel/Frame 064987/0939 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 20, 2023
From: BIODELIVERY SCIENCES INTERNATIONAL, INC.
To: SCILEX HOLDING COMPANY
Reel/Frame 063388/0141 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 8, 2023
From: MUNJAL, SAGAR; GAUTAM, ANIRUDH
To: DR. REDDY'S LABORATORIES LTD.
Reel/Frame 062921/0994 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 8, 2023
From: DR. REDDY'S LABORATORIES LTD.
To: BIODELIVERY SCIENCES INTERNATIONAL, INC.
Reel/Frame 062922/0122 →