NZ744112B2 - Treatments and prevention of opioid neonatal abstinence syndrome - Google Patents

Treatments and prevention of opioid neonatal abstinence syndrome

Info

Publication number
NZ744112B2
NZ744112B2 NZ744112A NZ74411217A NZ744112B2 NZ 744112 B2 NZ744112 B2 NZ 744112B2 NZ 744112 A NZ744112 A NZ 744112A NZ 74411217 A NZ74411217 A NZ 74411217A NZ 744112 B2 NZ744112 B2 NZ 744112B2
Authority
NZ
New Zealand
Prior art keywords
opioid
antagonist
opioid antagonist
subject
prevention
Prior art date
Application number
NZ744112A
Other versions
NZ744112A (en
Inventor
John Oberdick
Wolfgang Sadee
Original Assignee
Ohio State Innovation Foundation
Filing date
Publication date
Application filed by Ohio State Innovation Foundation filed Critical Ohio State Innovation Foundation
Priority claimed from PCT/US2017/012452 external-priority patent/WO2017120417A1/en
Publication of NZ744112A publication Critical patent/NZ744112A/en
Publication of NZ744112B2 publication Critical patent/NZ744112B2/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • A61K31/41781,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36Opioid-abuse

Abstract

Disclosed is a method for reducing or preventing fetal opioid dependence in a drug dependent or opioid tolerant pregnant subject. The method involves administering to the pregnant subject a composition comprising an opioid antagonist in an amount effective to reduce or prevent fetal opioid dependence, wherein the opioid antagonist a) is orally available or delivered systemically and reaches the circulation of the pregnant subject, b) is substantially excluded from the subject's brain by the blood brain barrier, and c) penetrates the placenta and enters the fetal brain. The method also includes administering the opioid antagonist to the neonate in increasing amounts to facilitate weaning the neonate from continued opioid maintenance.

Claims (21)

WHAT IS CLAIMED IS:
1. Use of an opioid antagonist in the manufacture of a medicament for reduction or prevention of opioid dependence of a fetus carried by a drug dependent or opioid tolerant pregnant subject receiving opioid therapy or maintenance, wherein the opioid antagonist is a neutral antagonist to a µ-opioid receptor.
2. The use of claim 1, wherein the opioid antagonist comprises 6ß-naltrexol.
3. The use of claim 1 or claim 2, wherein the opioid antagonist is delivered in two daily subdoses.
4. The use of any one of claims 1 to 3, wherein the opioid antagonist is delivered in a daily dosage range from about 0.1 mg to about 100 mg.
5. The use of any one of claims 1 to 4, wherein the medicament comprises a sustained drug release formulation.
6. The use of any one of claims 1 to 5, wherein the opioid antagonist is orally available.
7. The use of any one of claims 1 to 6, wherein the reduction or prevention further comprises administration of a palliative therapy.
8. The use of any one of claims 1 to 7, wherein the reduction or prevention further comprises administration of a 5-HT antagonist.
9. The use of claim 8, wherein the 5HT antagonist is ondansetron.
10. Use of an opioid antagonist in the manufacture of a medicament for the treatment of neonatal withdrawal or abstinence syndrome in an infant subject.
11. The use of claim 10, wherein the opioid antagonist comprises 6ß-naltrexol.
12. The use of claim 10 or claim 11, wherein the opioid antagonist is a neutral antagonist and not an inverse agonist.
13. The use of any one of claims 10 to 12, wherein the opioid antagonist does not comprise naloxone or naltrexone.
14. The use of any one of claims 10 to 13, wherein the opioid antagonist is delivered in two daily subdoses.
15. The use of any one of claims 10 to 14, wherein the opioid antagonist is delivered in a daily dosage range from about 0.1 mg to about 100 mg.
16. The use of any one of claims 10 to 15, wherein the opioid antagonist is comprised in a sustained drug release formulation.
17. The use of any one of claims 10 to 16, wherein the opioid antagonist is orally available.
18. The use of any one of claims 10 to 17, wherein the treatment further comprises administration of a palliative therapy to a pregnant subject and/or the infant subject.
19. The use of any one of claims 10 to 18, wherein the treatment further comprises administration of a 5-HT antagonist to a pregnant subject and/or the infant subject.
20. The use of claim 19, wherein the 5-HT antagonist is ondansetron.
21. Use of any one of claims 1 to 20, substantially as herein described with reference to any example thereof.
NZ744112A 2017-01-06 Treatments and prevention of opioid neonatal abstinence syndrome NZ744112B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662276691P 2016-01-08 2016-01-08
PCT/US2017/012452 WO2017120417A1 (en) 2016-01-08 2017-01-06 Treatments and prevention of opioid neonatal abstinence syndrome

Publications (2)

Publication Number Publication Date
NZ744112A NZ744112A (en) 2025-05-30
NZ744112B2 true NZ744112B2 (en) 2025-09-02

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