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Methods of administering intravenous meloxicam pre-operatively and in combination with other drugs

A meloxicam, intravenous technology, applied in the field of intravenous administration of meloxicam before surgery and in combination with other drugs, can solve the problems of serious complications, difficult side effects, prolonged hospital stay, etc.

Inactive Publication Date: 2020-06-30
BAUDAX BIO INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Intravenous (IV) administration of the NSAID ibuprofen was approved in 2009 for pain management; however, the infusion takes 30 minutes and must be administered every 6 hours for pain management
Furthermore, postoperative pain treatment and management has been fraught with difficulties due to the multiple significant side effects of the drugs currently used for this purpose that delay recovery, prolong hospital stays and put certain vulnerable patient populations at risk of serious complications

Method used

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  • Methods of administering intravenous meloxicam pre-operatively and in combination with other drugs
  • Methods of administering intravenous meloxicam pre-operatively and in combination with other drugs
  • Methods of administering intravenous meloxicam pre-operatively and in combination with other drugs

Examples

Experimental program
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Effect test

example 1

[0120] Example 1: Meloxicam 30mg IV Injection Formulation

[0121] The IV injection formulation is prepared as a ready-to-use formulation in a ready-to-use vial containing 30 mg meloxicam, povidone, sodium deoxycholate (deoxycholic acid), sucrose and water for injection in a total volume of 1 mL.

[0122] The placebo contained soybean oil, egg yolk phospholipids, glycerin, sodium fluorescein, sodium folate, disodium edetate, benzyl alcohol, polysorbate 80, dextrose, and water for injections. Hydrochloric acid and / or sodium hydroxide can be used for pH adjustment.

example 2

[0123] Example 2: Safety and efficacy of IV administration of meloxicam in combination with acetaminophen and gabapentin prior to colorectal surgery

[0124] An ongoing randomized, double-blind, placebo-controlled, multicenter study evaluating the safety of preoperative IV administration of meloxicam 30 mg in adult subjects undergoing open or laparoscopic colorectal surgery and effectiveness. The study cohort comprised approximately 50 subjects (1:1) randomized to 30 mg IV meloxicam or placebo. Adult subjects (ages 18 years (inclusive) to 80 years (inclusive)) scheduled to undergo colorectal surgery (expected to result in hospitalization for at least 48-72 hours) were screened for participation in the study at up to 20 study sites in the United States. Screening was performed within 28 days prior to IV administration of meloxicam. After signed informed consent, medical history, physical examination, laboratory tests, 12-lead electrocardiogram (ECG), pregnancy test, and vital...

example 3

[0131] Example 3: Safety and efficacy of IV administration of meloxicam in combination with acetaminophen and gabapentin before open unilateral total knee arthroplasty

[0132] method:A randomized, double-blind, placebo-controlled, multicenter study is ongoing to evaluate the safety of preoperative IV administration of meloxicam in adult subjects undergoing elective open unilateral total knee arthroplasty sex and effectiveness. Surgical procedures were performed in an inpatient hospital setting and were expected to result in a hospital stay of ≥24 hours. Each subject was screened within 28 days prior to surgery on Day 1. Prior to surgery, approximately 200 eligible subjects were randomized 1:1 to receive 30 mg IV meloxicam or placebo, administered as an intravenous (IV) bolus injection over ≤15 seconds.

[0133] Subjects received oral acetaminophen 650 mg and oral gabapentin 600 mg 30 to 90 minutes before the start of the planned surgical procedure. Subjects received appr...

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Abstract

The disclosure provides methods of treating pain in a patient who will be subjected to a surgical procedure, comprising administering meloxicam to the patient prior to start of the surgical procedure.In some embodiments, meloxicam is nanocrystalline meloxicam. The disclosure further provides methods of treating pain in a patient in need thereof, comprising administering meloxicam intravenously tothe patient in combination with acetaminophen and / or gabapentin.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 749,407, filed October 23, 2018, the contents of which are hereby incorporated by reference in their entirety for all purposes into this article. technical field [0003] The present disclosure relates to methods of administering meloxicam to treat pain, including preoperatively and / or in combination with other drugs. Background technique [0004] Meloxicam (4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide NSAIDs) are long-acting nonsteroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory, analgesic and antipyretic activities believed to be associated with inhibition of cyclooxygenase (COX) and subsequent reduction in prostaglandin biosynthesis. Boehringer Ingelheim Pharmaceuticals, Inc. has offered meloxicam as an oral form since the 1990s Bring t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/167A61K31/445A61K31/5415
CPCA61K31/167A61K31/5415A61K31/485A61K31/195A61K2300/00A61K45/06A61P29/00A61P41/00A61P23/00A61K9/0019A61K9/10
Inventor 兰德尔·J·马克斯图尔特·麦卡勒姆
Owner BAUDAX BIO INC
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