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Oral administration of peripherally-acting opioid antagonists

An opioid antagonist, the technology of action, applied in the field of pharmacology and medicine, can solve the problem of inability to eliminate the analgesic effect of opioids

Inactive Publication Date: 2011-04-13
NEKTAR THERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Naloxone cannot be used to treat the side effects of opioid administration, however it does not eliminate the analgesic effect of opioids

Method used

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  • Oral administration of peripherally-acting opioid antagonists
  • Oral administration of peripherally-acting opioid antagonists
  • Oral administration of peripherally-acting opioid antagonists

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] A double-blind, randomized, placebo-controlled multiple-dose study (double-blind, randomized, placebo-controlled, multiple-dose study) was conducted to evaluate the safety, tolerability and pharmacokinetics of compound I oral doses.

[0083] Thirty-two healthy male and female volunteer subjects were enrolled in this randomized, double-blind, placebo-controlled, multiple-dose dose-escalation study. The main enrollment criteria are: (i) age ≥ 18 and ≤ 65 years old; (ii) body mass index (BMI) ≥ 18 and ≤ 30kg / m 2 ; (iii) non-smokers, no history of drug abuse or alcohol abuse; (iv) normal frequency of bowel movements within the past month; and (v) female subjects must be postmenopausal or surgically menopausal. There were 16 male subjects and 16 female subjects participating in the study. Subjects ranged in age from 25 to 65 years. BMI (weight in kilograms divided by height in meters squared) ranges from 19 to 29.

[0084] The subjects were randomly divided into groups ac...

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Abstract

Peripherally-acting opioid antagonists can be orally administered to treat the side effects of opioid administration in convenient dosing schedules.

Description

[0001] Cross References to Related Applications [0002] Pursuant to 35 U.S.C. §119(e), this application claims priority to US Provisional Patent Application 61 / 126,868, filed May 7, 2008, which is hereby incorporated by reference in its entirety. technical field [0003] The present invention relates to a method of inhibiting the peripheral action of opioids by administering a therapeutically effective dose of a peripherally acting opioid antagonist. The present invention relates to the fields of pharmacology and medicine. Background of the invention [0004] Exogenous opioids are effective in relieving pain through their actions on receptors in the central nervous system; however, opioids also act on receptors in the enteric nervous system, thereby disrupting normal gastrointestinal function. See Panchal et al. (2007) Int J Clin Pract. 61(7):1181-1187 and Thomas (2008) J Pain Symptom Manage 35(1):103-113. Constipation is common and potentially attenuating adverse effects...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/485A61K31/765A61P1/00A61P25/04
CPCA61K31/765A61K31/485A61P1/00A61P1/04A61P1/10A61P25/04
Inventor 凯文·J·布罗德贝克艾伦·R·库格勒
Owner NEKTAR THERAPEUTICS INC
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