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

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....

AI Technical Summary

Benefits of technology

[0010]A pharmaceutical composition for avoidance of an arthropathy associated with treatment with an anti-nerve growth factor (NGF) antibody that binds specifically to NGF or an antigen binding fragment thereof is disclosed. In certain aspects, the composition is formulated as a dose of less than 9 mg of the anti-NGF antibody or the antigen binding fragment thereof. In certain aspects, the composition is formulated as a dose of less than 6 mg of the anti-NGF antibody or the antigen binding fragment thereof. In certain aspects, the initial dose and the one or more secondary doses of the pharmaceutical composition that reduces risk of development of an arthropathy each comprise about 1 mg, about 2 mg, about 3 mg, about 4 mg, or about 5 mg of the anti-NGF antibody or the antigen binding fragment thereof. In certain aspects, the initial dose and the one or more secondary doses of the pharmaceutical composition that reduces risk of development of an arthropathy each comprise about 1 mg or about 3 mg of the anti-NGF antibody or the antigen binding fragment thereof. In certain aspects, the arthropathy includes joint space narrowing exceeding pre-specified thresholds. In certain aspects, the arthropathy includes changes in bone structure evident on plain film. In certain aspects, the arthropathy includes changes in bone structure evident on plain film, joint space narrowing exceeding pre-specified thresholds, or both, in a knee joint. In certain aspects, the arthropathy includes changes in bone structure evident on plain film, joint space narrowing exceeding pre-specified thresholds, or both, in a hip joint. In certain aspects, the frequency of administration of a dose of the anti-NGF antibody that reduces risk of developing at least one arthropathy is about every 4 weeks.

[0014]In another aspect of the invention the use includes any of the above uses wherein a situation wherein standard analgesic therapy is inadvisable for administration to the patient due to safety and health risks to the patient and / or coupled with suboptimal efficacy. In another aspect of the invention the use includes any of the above uses wherein a situation wherein the standard analgesic therapy is inadvisable for administration to the patient due to a condition selected from the group consisting of medical contraindications, hypersensitivity to standard analgesic therapy, or excipients, use of a concomitant medication prohibited with standard analgesic therapy, increased risk of kidney damage, increased risk of liver damage, increased risk of gastrointestinal bleeding, increased risk of an allergic reaction and increased risk of developing drug dependence.

[0032]In certain aspects of the method of monitoring, if the subject has developed arthropathy, the subsequent treatment comprises administering a pharmaceutical composition comprising about 1.0 mg to about less than 6 mg of the anti-NGF antibody or an antigen binding fragment thereof, wherein the treatment reduces pain in the knee joint or the hip joint and reduces arthropathy.

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.

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