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Human Abuse Potential of the New Opioid Analgesic Molecule NKTR-181 Compared with Oxycodone
Abstract Objective Evaluate the human abuse potential, pharmacokinetics, pharmacodynamics, and safety of NKTR-181, a novel mu-opioid agonist molecule, relative to oxycodone. Design This randomized, single-center, double-blind, active- and placebo-controlled five-period crossover study enrolled healt...
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| Published in: | Pain medicine (Malden, Mass.) Mass.), 2018-02, Vol.19 (2), p.307-318 |
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| container_title | Pain medicine (Malden, Mass.) |
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| creator | Webster, Lynn Henningfield, Jack Buchhalter, August R Siddhanti, Suresh Lu, Lin Odinecs, Aleksandrs Di Fonzo, Carlo J Eldon, Michael A |
| description | Abstract
Objective
Evaluate the human abuse potential, pharmacokinetics, pharmacodynamics, and safety of NKTR-181, a novel mu-opioid agonist molecule, relative to oxycodone.
Design
This randomized, single-center, double-blind, active- and placebo-controlled five-period crossover study enrolled healthy, adult, non–physically dependent recreational opioid users.
Setting
Inpatient clinical research site.
Subjects
Forty-two randomized subjects (73.8% male, 81% white, mean age = 25 years).
Methods
The primary objective was to evaluate single orally administered 100, 200, and 400 mg NKTR-181 doses in solution compared with 40 mg oxycodone and placebo solutions using the Drug Liking visual analog scale. Secondary measures included the Drug Effects Questionnaire, Addiction Research Center Inventory/Morphine Benzedrine Group Subscale, Price Value Assessment Questionnaire, Global Assessment of Overall Drug Liking, and Take Drug Again Assessment. Central nervous system mu-opioid effects were assessed using pupillometry. The study included qualifying and treatment phases. Subjects received each of the five treatments using a crossover design.
Results
NKTR-181 at all dose levels had significantly lower Drug Liking Emax than oxycodone (P |
| doi_str_mv | 10.1093/pm/pnw344 |
| format | article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5914314</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A588343003</galeid><oup_id>10.1093/pm/pnw344</oup_id><sourcerecordid>A588343003</sourcerecordid><originalsourceid>FETCH-LOGICAL-c525t-f4951394b85e5cf90add8b51a2992b9fa754bf0a57f3ecce77473319a94ce1ed3</originalsourceid><addsrcrecordid>eNp9kk1v1DAQhi0Eou3CgT-ALMGhHNL6cx1fKq1WQBGFRaicOFiOM951lcQhTlj67_Fql0IRQrbkkeeZ15rXg9AzSs4o0fy8b8_7bsuFeICOqWTzQsy5eniIGVfyCJ2kdEMInYuSP0ZHrOSCUCGP0dfLqbUdXlRTAvwpjtCNwTY4ejxuAH-ELV71IYYaLzrbrCEFhz_EBtzU5Oz7688FLSlexra3A9R4G8YNXv24dbGOHTxBj7xtEjw9nDP05c3r6-VlcbV6-265uCqcZHIsvNCSci2qUoJ0XhNb12UlqWVas0p7q6SoPLFSeQ7OgVJCcU611cIBhZrP0MVet5-qFmqXexhsY_ohtHa4NdEGcz_ThY1Zx-9Gaip43jN0ehAY4rcJ0mjakBw0je0gTsnQsqRMEaVVRl_8hd7EacjeJMMywzVhkv-m1rYBEzof87tuJ2oWsszmc0J21Nk_qLxqaIPLBvqQ7-8VvNoXuCGmNIC_65ESs5sE07dmPwmZff6nKXfkr6_PwMs9EKf-Pzo_AcVxuYU</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2127390253</pqid></control><display><type>article</type><title>Human Abuse Potential of the New Opioid Analgesic Molecule NKTR-181 Compared with Oxycodone</title><source>Oxford Journals Online</source><creator>Webster, Lynn ; Henningfield, Jack ; Buchhalter, August R ; Siddhanti, Suresh ; Lu, Lin ; Odinecs, Aleksandrs ; Di Fonzo, Carlo J ; Eldon, Michael A</creator><creatorcontrib>Webster, Lynn ; Henningfield, Jack ; Buchhalter, August R ; Siddhanti, Suresh ; Lu, Lin ; Odinecs, Aleksandrs ; Di Fonzo, Carlo J ; Eldon, Michael A</creatorcontrib><description>Abstract
Objective
Evaluate the human abuse potential, pharmacokinetics, pharmacodynamics, and safety of NKTR-181, a novel mu-opioid agonist molecule, relative to oxycodone.
Design
This randomized, single-center, double-blind, active- and placebo-controlled five-period crossover study enrolled healthy, adult, non–physically dependent recreational opioid users.
Setting
Inpatient clinical research site.
Subjects
Forty-two randomized subjects (73.8% male, 81% white, mean age = 25 years).
Methods
The primary objective was to evaluate single orally administered 100, 200, and 400 mg NKTR-181 doses in solution compared with 40 mg oxycodone and placebo solutions using the Drug Liking visual analog scale. Secondary measures included the Drug Effects Questionnaire, Addiction Research Center Inventory/Morphine Benzedrine Group Subscale, Price Value Assessment Questionnaire, Global Assessment of Overall Drug Liking, and Take Drug Again Assessment. Central nervous system mu-opioid effects were assessed using pupillometry. The study included qualifying and treatment phases. Subjects received each of the five treatments using a crossover design.
Results
NKTR-181 at all dose levels had significantly lower Drug Liking Emax than oxycodone (P < 0.0001). Drug Liking scores for oxycodone increased rapidly within 15 minutes and peaked at approximately one hour postdose, whereas Drug Liking (and most secondary abuse potential measures) for all doses of NKTR-181 were comparable with placebo for at least the first hour. Only the 400 mg Drug Liking scores were minimally differentiated vs placebo from one and a half to four hours, but remained significantly lower than oxycodone (P < 0.003). NKTR-181 treatment-related adverse effects were mild and occurred at a lower rate compared with oxycodone.
Conclusions
NKTR-181 demonstrated delayed onset of CNS effects and significantly lower abuse potential scores compared with oxycodone in recreational opioid users.</description><identifier>ISSN: 1526-2375</identifier><identifier>EISSN: 1526-4637</identifier><identifier>DOI: 10.1093/pm/pnw344</identifier><identifier>PMID: 28340145</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Addiction ; Addictions ; Adult ; Analgesics ; Analgesics, Opioid - pharmacology ; Central nervous system ; Central nervous system depressants ; Chronic pain ; Clinical trials ; Cross-Over Studies ; Double-Blind Method ; Drug abuse ; Drug addiction ; Drug development ; Drug dosages ; Evidence-based medicine ; Female ; Health risk assessment ; Humans ; Male ; Medical research ; Morphinans - pharmacology ; Morphine ; Narcotics ; Novels ; Opioid receptors (type mu) ; Opioid-Related Disorders ; Opioids ; OPIOIDS & SUBSTANCE USE DISORDERS SECTION ; Oral administration ; Oxycodone ; Oxycodone - pharmacology ; Pharmacodynamics ; Pharmacokinetics ; Young Adult</subject><ispartof>Pain medicine (Malden, Mass.), 2018-02, Vol.19 (2), p.307-318</ispartof><rights>2017 American Academy of Pain Medicine. 2017</rights><rights>2017 American Academy of Pain Medicine.</rights><rights>COPYRIGHT 2018 Oxford University Press</rights><rights>Copyright © 2017 American Academy of Pain Medicine</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c525t-f4951394b85e5cf90add8b51a2992b9fa754bf0a57f3ecce77473319a94ce1ed3</citedby><cites>FETCH-LOGICAL-c525t-f4951394b85e5cf90add8b51a2992b9fa754bf0a57f3ecce77473319a94ce1ed3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28340145$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Webster, Lynn</creatorcontrib><creatorcontrib>Henningfield, Jack</creatorcontrib><creatorcontrib>Buchhalter, August R</creatorcontrib><creatorcontrib>Siddhanti, Suresh</creatorcontrib><creatorcontrib>Lu, Lin</creatorcontrib><creatorcontrib>Odinecs, Aleksandrs</creatorcontrib><creatorcontrib>Di Fonzo, Carlo J</creatorcontrib><creatorcontrib>Eldon, Michael A</creatorcontrib><title>Human Abuse Potential of the New Opioid Analgesic Molecule NKTR-181 Compared with Oxycodone</title><title>Pain medicine (Malden, Mass.)</title><addtitle>Pain Med</addtitle><description>Abstract
Objective
Evaluate the human abuse potential, pharmacokinetics, pharmacodynamics, and safety of NKTR-181, a novel mu-opioid agonist molecule, relative to oxycodone.
Design
This randomized, single-center, double-blind, active- and placebo-controlled five-period crossover study enrolled healthy, adult, non–physically dependent recreational opioid users.
Setting
Inpatient clinical research site.
Subjects
Forty-two randomized subjects (73.8% male, 81% white, mean age = 25 years).
Methods
The primary objective was to evaluate single orally administered 100, 200, and 400 mg NKTR-181 doses in solution compared with 40 mg oxycodone and placebo solutions using the Drug Liking visual analog scale. Secondary measures included the Drug Effects Questionnaire, Addiction Research Center Inventory/Morphine Benzedrine Group Subscale, Price Value Assessment Questionnaire, Global Assessment of Overall Drug Liking, and Take Drug Again Assessment. Central nervous system mu-opioid effects were assessed using pupillometry. The study included qualifying and treatment phases. Subjects received each of the five treatments using a crossover design.
Results
NKTR-181 at all dose levels had significantly lower Drug Liking Emax than oxycodone (P < 0.0001). Drug Liking scores for oxycodone increased rapidly within 15 minutes and peaked at approximately one hour postdose, whereas Drug Liking (and most secondary abuse potential measures) for all doses of NKTR-181 were comparable with placebo for at least the first hour. Only the 400 mg Drug Liking scores were minimally differentiated vs placebo from one and a half to four hours, but remained significantly lower than oxycodone (P < 0.003). NKTR-181 treatment-related adverse effects were mild and occurred at a lower rate compared with oxycodone.
Conclusions
NKTR-181 demonstrated delayed onset of CNS effects and significantly lower abuse potential scores compared with oxycodone in recreational opioid users.</description><subject>Addiction</subject><subject>Addictions</subject><subject>Adult</subject><subject>Analgesics</subject><subject>Analgesics, Opioid - pharmacology</subject><subject>Central nervous system</subject><subject>Central nervous system depressants</subject><subject>Chronic pain</subject><subject>Clinical trials</subject><subject>Cross-Over Studies</subject><subject>Double-Blind Method</subject><subject>Drug abuse</subject><subject>Drug addiction</subject><subject>Drug development</subject><subject>Drug dosages</subject><subject>Evidence-based medicine</subject><subject>Female</subject><subject>Health risk assessment</subject><subject>Humans</subject><subject>Male</subject><subject>Medical research</subject><subject>Morphinans - pharmacology</subject><subject>Morphine</subject><subject>Narcotics</subject><subject>Novels</subject><subject>Opioid receptors (type mu)</subject><subject>Opioid-Related Disorders</subject><subject>Opioids</subject><subject>OPIOIDS & SUBSTANCE USE DISORDERS SECTION</subject><subject>Oral administration</subject><subject>Oxycodone</subject><subject>Oxycodone - pharmacology</subject><subject>Pharmacodynamics</subject><subject>Pharmacokinetics</subject><subject>Young Adult</subject><issn>1526-2375</issn><issn>1526-4637</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><recordid>eNp9kk1v1DAQhi0Eou3CgT-ALMGhHNL6cx1fKq1WQBGFRaicOFiOM951lcQhTlj67_Fql0IRQrbkkeeZ15rXg9AzSs4o0fy8b8_7bsuFeICOqWTzQsy5eniIGVfyCJ2kdEMInYuSP0ZHrOSCUCGP0dfLqbUdXlRTAvwpjtCNwTY4ejxuAH-ELV71IYYaLzrbrCEFhz_EBtzU5Oz7688FLSlexra3A9R4G8YNXv24dbGOHTxBj7xtEjw9nDP05c3r6-VlcbV6-265uCqcZHIsvNCSci2qUoJ0XhNb12UlqWVas0p7q6SoPLFSeQ7OgVJCcU611cIBhZrP0MVet5-qFmqXexhsY_ohtHa4NdEGcz_ThY1Zx-9Gaip43jN0ehAY4rcJ0mjakBw0je0gTsnQsqRMEaVVRl_8hd7EacjeJMMywzVhkv-m1rYBEzof87tuJ2oWsszmc0J21Nk_qLxqaIPLBvqQ7-8VvNoXuCGmNIC_65ESs5sE07dmPwmZff6nKXfkr6_PwMs9EKf-Pzo_AcVxuYU</recordid><startdate>20180201</startdate><enddate>20180201</enddate><creator>Webster, Lynn</creator><creator>Henningfield, Jack</creator><creator>Buchhalter, August R</creator><creator>Siddhanti, Suresh</creator><creator>Lu, Lin</creator><creator>Odinecs, Aleksandrs</creator><creator>Di Fonzo, Carlo J</creator><creator>Eldon, Michael A</creator><general>Oxford University Press</general><scope>TOX</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20180201</creationdate><title>Human Abuse Potential of the New Opioid Analgesic Molecule NKTR-181 Compared with Oxycodone</title><author>Webster, Lynn ; Henningfield, Jack ; Buchhalter, August R ; Siddhanti, Suresh ; Lu, Lin ; Odinecs, Aleksandrs ; Di Fonzo, Carlo J ; Eldon, Michael A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c525t-f4951394b85e5cf90add8b51a2992b9fa754bf0a57f3ecce77473319a94ce1ed3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Addiction</topic><topic>Addictions</topic><topic>Adult</topic><topic>Analgesics</topic><topic>Analgesics, Opioid - pharmacology</topic><topic>Central nervous system</topic><topic>Central nervous system depressants</topic><topic>Chronic pain</topic><topic>Clinical trials</topic><topic>Cross-Over Studies</topic><topic>Double-Blind Method</topic><topic>Drug abuse</topic><topic>Drug addiction</topic><topic>Drug development</topic><topic>Drug dosages</topic><topic>Evidence-based medicine</topic><topic>Female</topic><topic>Health risk assessment</topic><topic>Humans</topic><topic>Male</topic><topic>Medical research</topic><topic>Morphinans - pharmacology</topic><topic>Morphine</topic><topic>Narcotics</topic><topic>Novels</topic><topic>Opioid receptors (type mu)</topic><topic>Opioid-Related Disorders</topic><topic>Opioids</topic><topic>OPIOIDS & SUBSTANCE USE DISORDERS SECTION</topic><topic>Oral administration</topic><topic>Oxycodone</topic><topic>Oxycodone - pharmacology</topic><topic>Pharmacodynamics</topic><topic>Pharmacokinetics</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Webster, Lynn</creatorcontrib><creatorcontrib>Henningfield, Jack</creatorcontrib><creatorcontrib>Buchhalter, August R</creatorcontrib><creatorcontrib>Siddhanti, Suresh</creatorcontrib><creatorcontrib>Lu, Lin</creatorcontrib><creatorcontrib>Odinecs, Aleksandrs</creatorcontrib><creatorcontrib>Di Fonzo, Carlo J</creatorcontrib><creatorcontrib>Eldon, Michael A</creatorcontrib><collection>Oxford University Press Journals Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Databases</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Pain medicine (Malden, Mass.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Webster, Lynn</au><au>Henningfield, Jack</au><au>Buchhalter, August R</au><au>Siddhanti, Suresh</au><au>Lu, Lin</au><au>Odinecs, Aleksandrs</au><au>Di Fonzo, Carlo J</au><au>Eldon, Michael A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Human Abuse Potential of the New Opioid Analgesic Molecule NKTR-181 Compared with Oxycodone</atitle><jtitle>Pain medicine (Malden, Mass.)</jtitle><addtitle>Pain Med</addtitle><date>2018-02-01</date><risdate>2018</risdate><volume>19</volume><issue>2</issue><spage>307</spage><epage>318</epage><pages>307-318</pages><issn>1526-2375</issn><eissn>1526-4637</eissn><abstract>Abstract
Objective
Evaluate the human abuse potential, pharmacokinetics, pharmacodynamics, and safety of NKTR-181, a novel mu-opioid agonist molecule, relative to oxycodone.
Design
This randomized, single-center, double-blind, active- and placebo-controlled five-period crossover study enrolled healthy, adult, non–physically dependent recreational opioid users.
Setting
Inpatient clinical research site.
Subjects
Forty-two randomized subjects (73.8% male, 81% white, mean age = 25 years).
Methods
The primary objective was to evaluate single orally administered 100, 200, and 400 mg NKTR-181 doses in solution compared with 40 mg oxycodone and placebo solutions using the Drug Liking visual analog scale. Secondary measures included the Drug Effects Questionnaire, Addiction Research Center Inventory/Morphine Benzedrine Group Subscale, Price Value Assessment Questionnaire, Global Assessment of Overall Drug Liking, and Take Drug Again Assessment. Central nervous system mu-opioid effects were assessed using pupillometry. The study included qualifying and treatment phases. Subjects received each of the five treatments using a crossover design.
Results
NKTR-181 at all dose levels had significantly lower Drug Liking Emax than oxycodone (P < 0.0001). Drug Liking scores for oxycodone increased rapidly within 15 minutes and peaked at approximately one hour postdose, whereas Drug Liking (and most secondary abuse potential measures) for all doses of NKTR-181 were comparable with placebo for at least the first hour. Only the 400 mg Drug Liking scores were minimally differentiated vs placebo from one and a half to four hours, but remained significantly lower than oxycodone (P < 0.003). NKTR-181 treatment-related adverse effects were mild and occurred at a lower rate compared with oxycodone.
Conclusions
NKTR-181 demonstrated delayed onset of CNS effects and significantly lower abuse potential scores compared with oxycodone in recreational opioid users.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>28340145</pmid><doi>10.1093/pm/pnw344</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1526-2375 |
| ispartof | Pain medicine (Malden, Mass.), 2018-02, Vol.19 (2), p.307-318 |
| issn | 1526-2375 1526-4637 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5914314 |
| source | Oxford Journals Online |
| subjects | Addiction Addictions Adult Analgesics Analgesics, Opioid - pharmacology Central nervous system Central nervous system depressants Chronic pain Clinical trials Cross-Over Studies Double-Blind Method Drug abuse Drug addiction Drug development Drug dosages Evidence-based medicine Female Health risk assessment Humans Male Medical research Morphinans - pharmacology Morphine Narcotics Novels Opioid receptors (type mu) Opioid-Related Disorders Opioids OPIOIDS & SUBSTANCE USE DISORDERS SECTION Oral administration Oxycodone Oxycodone - pharmacology Pharmacodynamics Pharmacokinetics Young Adult |
| title | Human Abuse Potential of the New Opioid Analgesic Molecule NKTR-181 Compared with Oxycodone |
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