Naloxone without the needle − systematic review of candidate routes for non-injectable naloxone for opioid overdose reversal

John Strang; Rebecca McDonald; Abdulmalik Alqurshi; Paul Royall; David Taylor; Ben Forbes

doi:10.1016/j.drugalcdep.2016.02.042

Naloxone without the needle − systematic review of candidate routes for non-injectable naloxone for opioid overdose reversal

John Strang, Rebecca McDonald, Abdulmalik Alqurshi, Paul Royall, David Taylor, Ben Forbes

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Abstract

AbstractIntroduction Deaths from opioid overdose can be prevented through administration of the antagonist naloxone, which has been licensed for injection since the 1970s. To support wider availability of naloxone in community settings, novel non-injectable naloxone formulations are being developed, suitable for emergency use by non-medical personnel. Objectives 1) Identify candidate routes of injection-free naloxone administration potentially suitable for emergency overdose reversal; 2) consider pathways for developing and evaluating novel naloxone formulations. Methods A three-stage analysis of candidate routes of administration was conducted: 1) Assessment of all 112 routes of administration identified by FDA against exclusion criteria. 2) Scrutiny of empirical data for identified candidate routes, searching PubMed and WHO International Clinical Trials Registry Platform using search terms “naloxone AND [route of administration]”. 3) Examination of routes for feasibility and against the inclusion criteria. Results Only three routes of administration met inclusion criteria: nasal, sublingual and buccal. Products are currently in development and being studied. Pharmacokinetic data exist only for nasal naloxone, for which product development is more advanced, and one concentrated nasal spray was granted licence in the US in 2015. However, buccal naloxone may also be viable and may have different characteristics. Conclusion After 40 years of injection-based naloxone treatment, non-injectable routes are finally being developed. Nasal naloxone has recently been approved and will soon be field-tested, buccal naloxone holds promise, and it is unclear what sublingual naloxone will contribute. Development and approval of reliable non-injectable formulations will facilitate wider naloxone provision across the community internationally.

Original language	English
Pages (from-to)	16-23
Journal	Drug and alcohol dependence
Volume	163
Early online date	9 Mar 2016
DOIs	https://doi.org/10.1016/j.drugalcdep.2016.02.042
Publication status	Published - 1 Jun 2016

Keywords

naloxone
drug development
heroin
opioid
overdose
deaths
nasal
buccal
sublingual

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10.1016/j.drugalcdep.2016.02.042

Naloxone without the needle_STRANG_Firstonline9March2016_GREEN AAM (CC BY-NC-ND)Accepted author manuscript, 758 KBLicence: CC BY-NC-ND

Cite this

@article{675f26eb78c7476abc26fce13d274aca,

title = "Naloxone without the needle − systematic review of candidate routes for non-injectable naloxone for opioid overdose reversal",

abstract = "AbstractIntroduction Deaths from opioid overdose can be prevented through administration of the antagonist naloxone, which has been licensed for injection since the 1970s. To support wider availability of naloxone in community settings, novel non-injectable naloxone formulations are being developed, suitable for emergency use by non-medical personnel. Objectives 1) Identify candidate routes of injection-free naloxone administration potentially suitable for emergency overdose reversal; 2) consider pathways for developing and evaluating novel naloxone formulations. Methods A three-stage analysis of candidate routes of administration was conducted: 1) Assessment of all 112 routes of administration identified by FDA against exclusion criteria. 2) Scrutiny of empirical data for identified candidate routes, searching PubMed and WHO International Clinical Trials Registry Platform using search terms “naloxone AND [route of administration]”. 3) Examination of routes for feasibility and against the inclusion criteria. Results Only three routes of administration met inclusion criteria: nasal, sublingual and buccal. Products are currently in development and being studied. Pharmacokinetic data exist only for nasal naloxone, for which product development is more advanced, and one concentrated nasal spray was granted licence in the US in 2015. However, buccal naloxone may also be viable and may have different characteristics. Conclusion After 40 years of injection-based naloxone treatment, non-injectable routes are finally being developed. Nasal naloxone has recently been approved and will soon be field-tested, buccal naloxone holds promise, and it is unclear what sublingual naloxone will contribute. Development and approval of reliable non-injectable formulations will facilitate wider naloxone provision across the community internationally.",

keywords = "naloxone, drug development, heroin, opioid, overdose, deaths, nasal, buccal, sublingual",

author = "John Strang and Rebecca McDonald and Abdulmalik Alqurshi and Paul Royall and David Taylor and Ben Forbes",

year = "2016",

month = jun,

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doi = "10.1016/j.drugalcdep.2016.02.042",

language = "English",

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journal = "Drug and alcohol dependence",

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T1 - Naloxone without the needle − systematic review of candidate routes for non-injectable naloxone for opioid overdose reversal

AU - Strang, John

AU - McDonald, Rebecca

AU - Alqurshi, Abdulmalik

AU - Royall, Paul

AU - Taylor, David

AU - Forbes, Ben

PY - 2016/6/1

Y1 - 2016/6/1

N2 - AbstractIntroduction Deaths from opioid overdose can be prevented through administration of the antagonist naloxone, which has been licensed for injection since the 1970s. To support wider availability of naloxone in community settings, novel non-injectable naloxone formulations are being developed, suitable for emergency use by non-medical personnel. Objectives 1) Identify candidate routes of injection-free naloxone administration potentially suitable for emergency overdose reversal; 2) consider pathways for developing and evaluating novel naloxone formulations. Methods A three-stage analysis of candidate routes of administration was conducted: 1) Assessment of all 112 routes of administration identified by FDA against exclusion criteria. 2) Scrutiny of empirical data for identified candidate routes, searching PubMed and WHO International Clinical Trials Registry Platform using search terms “naloxone AND [route of administration]”. 3) Examination of routes for feasibility and against the inclusion criteria. Results Only three routes of administration met inclusion criteria: nasal, sublingual and buccal. Products are currently in development and being studied. Pharmacokinetic data exist only for nasal naloxone, for which product development is more advanced, and one concentrated nasal spray was granted licence in the US in 2015. However, buccal naloxone may also be viable and may have different characteristics. Conclusion After 40 years of injection-based naloxone treatment, non-injectable routes are finally being developed. Nasal naloxone has recently been approved and will soon be field-tested, buccal naloxone holds promise, and it is unclear what sublingual naloxone will contribute. Development and approval of reliable non-injectable formulations will facilitate wider naloxone provision across the community internationally.

AB - AbstractIntroduction Deaths from opioid overdose can be prevented through administration of the antagonist naloxone, which has been licensed for injection since the 1970s. To support wider availability of naloxone in community settings, novel non-injectable naloxone formulations are being developed, suitable for emergency use by non-medical personnel. Objectives 1) Identify candidate routes of injection-free naloxone administration potentially suitable for emergency overdose reversal; 2) consider pathways for developing and evaluating novel naloxone formulations. Methods A three-stage analysis of candidate routes of administration was conducted: 1) Assessment of all 112 routes of administration identified by FDA against exclusion criteria. 2) Scrutiny of empirical data for identified candidate routes, searching PubMed and WHO International Clinical Trials Registry Platform using search terms “naloxone AND [route of administration]”. 3) Examination of routes for feasibility and against the inclusion criteria. Results Only three routes of administration met inclusion criteria: nasal, sublingual and buccal. Products are currently in development and being studied. Pharmacokinetic data exist only for nasal naloxone, for which product development is more advanced, and one concentrated nasal spray was granted licence in the US in 2015. However, buccal naloxone may also be viable and may have different characteristics. Conclusion After 40 years of injection-based naloxone treatment, non-injectable routes are finally being developed. Nasal naloxone has recently been approved and will soon be field-tested, buccal naloxone holds promise, and it is unclear what sublingual naloxone will contribute. Development and approval of reliable non-injectable formulations will facilitate wider naloxone provision across the community internationally.

KW - naloxone

KW - drug development

KW - heroin

KW - opioid

KW - overdose

KW - deaths

KW - nasal

KW - buccal

KW - sublingual

U2 - 10.1016/j.drugalcdep.2016.02.042

DO - 10.1016/j.drugalcdep.2016.02.042

M3 - Article

SN - 0376-8716

VL - 163

SP - 16

EP - 23

JO - Drug and alcohol dependence

JF - Drug and alcohol dependence

ER -

Naloxone without the needle − systematic review of candidate routes for non-injectable naloxone for opioid overdose reversal

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Keywords

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