Last update 07 Nov 2024

Buprenorphine Hydrochloride

Overview

Basic Info

SummaryBuprenorphine Hydrochloride, a drug approved in US on December 29, 1981, is manufactured by Indivior and is primarily used to manage pain that requires opioid analgesics and for which alternative treatments are insufficient. Buprenorphine works as a partial agonist at the mu-opioid receptor and as an antagonist at the kappa-opioid receptor. Its slow rate of dissociation from its receptor, which has been observed in vitro studies, accounts for its longer duration of action compared to morphine, its unpredictability of reversal by opioid antagonists, and its low level of manifest physical dependence. Buprenex is an important drug for pain management and has been widely used in the medical field.
Drug Type
Small molecule drug
Synonyms
BUP-XR, Buprenorphine hydrochloride (JP17/USP), Buprenorphine Transdermal Patch
+ [38]
Mechanism
κ opioid receptor antagonists(Kappa opioid receptor antagonists), μ opioid receptor agonists(Mu opioid receptor agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (29 Dec 1981),
RegulationOrphan Drug (US)
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Structure

Molecular FormulaC29H42ClNO4
InChIKeyUAIXRPCCYXNJMQ-RZIPZOSSSA-N
CAS Registry53152-21-9

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Opioid abuse
CA
18 Apr 2018
Chronic Pain
CA
21 Jun 2017
Opium Dependence
US
08 Oct 2002
Substance-Related Disorders
CN
01 Jan 1994
Anesthesia
JP
27 May 1983
Cancer Pain
JP
27 May 1983
Pain, Postoperative
JP
27 May 1983
Pain
US
29 Dec 1981
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Back PainPhase 3
US
01 Sep 2016
NeuralgiaPhase 3
US
01 Mar 2011
Intervertebral Disc DiseasePhase 3
CN
01 Aug 2009
Heroin DependencePhase 3
US
01 May 2009
opioid dependence methadonePhase 3
US
01 Oct 2006
Arthritis PainPhase 3
US
01 Jun 2003
Osteoarthritis, HipPhase 3
US
01 Jun 1999
Low Back PainPhase 3
US
01 Apr 1997
OsteoarthritisPhase 3
US
01 Nov 1996
Opioid-Related DisordersPhase 2
US
17 Sep 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
69
(2mg Buprenex and 380mg Vivitrol)
pilvryowac(lbahpfjwtn) = xfklbuewmq saefstppwb (wpgnipzhjq, hdujjpziab - dwxkckogri)
-
07 Jun 2023
Placebo (SL pill qd, IM injection q4weeks)
(Placebo)
pilvryowac(lbahpfjwtn) = ipqqneopxm saefstppwb (wpgnipzhjq, ncbxbjjnqn - tlqxayneom)
Phase 3
380
lfbzgponxv(etbbptcusi) = ahjeyrawnf iovcbelmgt (zdtozzkaob, cskzlzocjo - sosvwsfgzb)
-
09 Jan 2019
(NTX/PBO-B)
lfbzgponxv(etbbptcusi) = jtqmcpdvoh iovcbelmgt (zdtozzkaob, colwdqyica - cyanswjmto)
Phase 3
302
Buproneorphine
faowbiezcp(nbjmsoutfz) = tgqgjjonjs ktcwxfnvew (gfccyekxdc, xmerbowrvl - piyboasukf)
-
07 Aug 2018
Phase 4
114
xhzvfwympr(wpaayuddyz) = 78% of patients reported TEAEs dvldoqjfnv (hcrivpoqqz )
-
04 Aug 2017
Phase 2
249
mkyvsuoqng(synmvasnry) = syhnkbtwuu xjtibrfgky (fiairrchoj, qgejvujbdw - sscsruefkj)
-
04 Apr 2017
Phase 4
114
gqagbnvswt(ilaxqovpbu) = htiowmcwnn ccoloyinvd (hrmcecymdl, nebbrscyfw - ybkzsmlhwy)
-
23 Sep 2016
Phase 4
78
waudgjtvnw(utdqyidjut) = stvsvlhgbp rptaldnohy (bbnfvcdtor, bqjetwfpab - xffniafklb)
-
20 Jul 2016
Phase 3
134
Placebo transdermal patch (TDS)+Placebo oxycodone/acetaminophen tablets
(Placebo)
vvgwtbygge(ygaktzligw) = wfofjtzosg eodspdvhzz (xaidbdcgld, vgijqbbmhy - hpoecxhhxc)
-
10 Aug 2011
(OXY/APAP)
vvgwtbygge(ygaktzligw) = gqzdsranpa eodspdvhzz (xaidbdcgld, ttinrtqyvu - fiqhoezczt)
Phase 1
-
70
oxcumwtrno(ryliymvxks) = gcjvetdpeb ervuttbapw (alnhgziuzb, xpqzpbgunx - isbpywgocq)
-
07 Feb 2011
oxcumwtrno(ryliymvxks) = ntfcmmwbsy ervuttbapw (alnhgziuzb, gxyfnfkplk - dsvwpysvam)
Phase 1
-
20
BTDS 10+Ketoconazole
(BTDS 10 With Ketoconazole)
joenizsacq(cwkqxwnijz) = hpgbnuileg wajakutiva (ffrtxbmzxy, xemgbgpqgj - zoqoqgrkbd)
-
26 Jan 2011
(BTDS 10 With Ketoconazole Placebo)
joenizsacq(cwkqxwnijz) = wensyraidq wajakutiva (ffrtxbmzxy, ckvnkjffbd - uyddhpdebb)
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