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Pharmaceutical Composition for Safe and Effective Treatment of Knee and/or Hip Pain

a technology of drugs and compositions, applied in the field of treating or preventing pain in joints, can solve the problems of adverse central nervous system effects, inability to provide adequate pain relief for inability to meet the needs of patients with acute and chronic pain, so as to reduce pain in the knee joint and reduce arthropathy.

Pending Publication Date: 2022-02-10
REGENERON PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

Fasinumab effectively reduces knee and hip pain in patients unresponsive or intolerant to standard analgesic therapy, improving pain-associated parameters and reducing the risk of arthropathy, while offering a safer alternative to traditional pain management options.

Problems solved by technology

Many patients with acute and chronic pain do not receive adequate pain relief despite the wide variety of analgesic medications that are currently available, either because the medications are not effective in all patients, or because their use is limited by toxicity or intolerability.
The limitations of currently available analgesic therapies include adverse central nervous system effects, nausea and vomiting, constipation, gastrointestinal bleeding and ulceration, cardiovascular events, renal toxicity, and potential for abuse.
Inadequate pain relief has a profound impact on the quality of life for millions of people worldwide with an associated substantial cost to society, including healthcare cost and loss of productivity.

Method used

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  • Pharmaceutical Composition for Safe and Effective Treatment of Knee and/or Hip Pain
  • Pharmaceutical Composition for Safe and Effective Treatment of Knee and/or Hip Pain
  • Pharmaceutical Composition for Safe and Effective Treatment of Knee and/or Hip Pain

Examples

Experimental program
Comparison scheme
Effect test

example 1

Patients and Methods

[0206]Patients. Eligible patients were 40-80 years of age; had a diagnosis of OA of the knee and / or hip (designated the most symptomatic, index joint at the time of the screening visit) based on the American College of Rheumatology criteria for OA with radiologic confirmation (Kellgren-Lawrence [K-L] grading of ≥2 on a scale of 0-4); and demonstrated moderate-to-severe pain in the index joint, defined as a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score of ≥4, at both the screening while on usual analgesic medication and at the randomization visit, which occurred 7 days after withdrawal of analgesic therapy. Patients were required to have a history of inadequate pain relief with or intolerance to acetaminophen and ≥1 oral NSAID, and a history of inadequate pain relief with, intolerance to, or unwillingness to use opioids. Patients were also required to have a history of regular analgesic use for OA pain (average of 4 day...

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PUM

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Abstract

A pharmaceutical composition and a method for treating knee and / or hip pain in a patient non-responsive or intolerant to standard analgesic therapy are disclosed. A pharmaceutical composition and a method for reducing risk for developing an arthropathy in a subject receiving an anti-NGF antibody for treatment of knee and / or hip pain are disclosed. Also provided herein are methods for monitoring safety of a treatment of knee and / or hip pain involving administration of an anti-NGF antibody. In certain aspects, the subject has osteoarthritis of the knee and / or hip and the anti-NGF antibody is fasinumab.

Description

FIELD OF THE INVENTION[0001]The present invention relates to the treatment, or prevention of pain in joints such as the knee joint or the hip joint in patients who have a history of inadequate pain relief, or intolerance to standard analgesic therapy. More specifically, the invention relates to the administration of NGF antagonists, in particular a nerve growth factor (NGF) antibody, to reduce knee and / or hip pain in a patient in need thereof.BACKGROUND[0002]Many patients with acute and chronic pain do not receive adequate pain relief despite the wide variety of analgesic medications that are currently available, either because the medications are not effective in all patients, or because their use is limited by toxicity or intolerability. The limitations of currently available analgesic therapies include adverse central nervous system effects, nausea and vomiting, constipation, gastrointestinal bleeding and ulceration, cardiovascular events, renal toxicity, and potential for abuse....

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C07K16/22A61P29/00A61K39/395A61P25/02
CPCC07K16/22A61P29/00A61P19/02A61P25/02C07K2317/565A61K39/3955A61K2039/505A61K2039/54A61K2039/545
Inventor GEBA, GREGORYDAKIN, PAULADIMARTINO, STEPHENGAO, HAITAOMALONEY, JENNIFERDAVIS, JOHNBREEN, CATHERINE STEHMAN
Owner REGENERON PHARM INC
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