Compositions and methods for intrathecal administration of MCOPPB for pain relief
Inventors
Campbell, James N. • Manning, Barton Harley
Assignees
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Abstract
The invention provides compositions and methods for intrathecal administration of the compound MCOPPB or a pharmaceutically acceptable salt thereof for treating pain, such as neuropathic pain suffered by an adult human.
Core Innovation
The invention provides a method of treating pain by intrathecally administering to a human patient in need thereof a therapeutically effective amount of a pharmaceutical composition comprising MCOPPB or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier. The administering delivers a daily dose of MCOPPB within specified ranges to thereby treat the pain, and the treated pain includes neuropathic pain in adult humans, with long-duration pain relief via continuous intrathecal delivery.
The invention further describes continuous intrathecal administration, optionally via an implanted, programmable pump device such as an osmotic pump with a spinal catheter. Formulation aspects include sterile isotonic solutions and pharmaceutically acceptable carriers, including aqueous and non-aqueous carriers, and buffers and preservatives, and the compositions may include stereochemical purity and enantiomeric excess.
The invention includes medical kits related to the intrathecal administration of MCOPPB compositions for treating pain. Non-limiting pharmacology and efficacy data are described, including tail-flick assay results showing dose-dependent thermal analgesia after intrathecal MCOPPB and osteoarthritis-related efficacy in a monosodium-iodoacetate model showing reduced lameness across early and late phases and behavioral improvement in locomotor activity, with reference to morphine as a positive control.
Claims Coverage
Two independent claims are identified. Each independent claim covers an intrathecal method for treating pain in a human patient using MCOPPB or a pharmaceutically acceptable salt thereof in a pharmaceutically acceptable carrier, with the main distinction being the specified daily dose range of MCOPPB.
Intrathecally administering MCOPPB or a pharmaceutically acceptable salt with a pharmaceutically acceptable carrier to treat pain
A method of treating a human patient suffering from pain comprising intrathecally administering a therapeutically effective amount of a pharmaceutical composition comprising MCOPPB or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier to thereby treat the pain.
Daily intrathecal MCOPPB dose in a low range of about 0.1 µg to 10 µg
The administering delivers a daily dose of MCOPPB in the range of about 0.1 µg to 10 µg.
Daily intrathecal MCOPPB dose in a higher range of about 10 µg to 50 µg
The administering delivers a daily dose of MCOPPB in the range of about 10 µg to 50 µg.
Overall, the claim coverage focuses on intrathecal treatment of human pain using MCOPPB or pharmaceutically acceptable salts formulated with a pharmaceutically acceptable carrier, where independent claims distinguish the daily intrathecal dose range into about 0.1-10 µg and about 10-50 µg. Dependent claims further narrow pain indications, including neuropathic pain, inflammatory pain, and low back pain, and add effectiveness constraints and specific subranges within the daily dose ranges.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating neuropathic pain in adult humans via intrathecal administration of MCOPPB compositions with long-duration pain relief.
Treating pain due to cancer, where pain is associated with a selected cancer from a list of cancer types including bladder cancer, breast cancer, cervical cancer, colon cancer, colorectal cancer, endometrial cancer, esophageal cancer, leukemia, lung cancer, liver cancer, skin cancer, ovarian cancer, pancreatic cancer, prostate cancer, rectal cancer, renal cancer, stomach cancer, testicular cancer, and uterine cancer.
Treating low back pain via intrathecal administration of the MCOPPB composition.
Treating pain associated with complex regional pain syndrome, where the complex regional pain syndrome is reflex sympathetic dystrophy pain.
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