SummaryNaltrexone, an opioid antagonist, has been utilized for treating addiction to both drugs and alcohol. VIVITROL, a medication containing naltrexone, is approved for patients with alcohol dependence who can abstain from alcohol before medication initiation. At the initial administration of VIVITROL, patients must not be actively drinking. Following opioid detoxification, VIVITROL can also be utilized to prevent relapse to opioid dependence. It is vital to keep in mind that VIVITROL should be incorporated into a comprehensive management program that includes psychosocial support. Naltrexone works by blocking opioid receptors, specifically the mu/kappa/delta receptors, thus preventing the effects of opioids. Unlike buprenorphine and methadone that activate opioid receptors to suppress cravings, naltrexone binds and blocks opioid receptors, reducing opioid cravings. Moreover, it does not cause withdrawal symptoms upon discontinuation and does not possess abuse and diversion potential. |
Drug Type Small molecule drug |
Synonyms DBR-LDN, Naltrexone implant, naltrexone prodrugs (transdermal/microneedle, opioid dependence/alcoholism), AllTranz/University of Kentucky + [10] |
Mechanism Opioid receptors antagonists(Opioid receptors antagonists), μ opioid receptor antagonists(Mu opioid receptor antagonists) |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Drug Highest PhaseApproved |
First Approval Date US (13 Apr 2006), |
RegulationOrphan Drug (US), Priority Review (CN) |
Molecular FormulaC20H23NO4 |
InChIKeyDQCKKXVULJGBQN-XFWGSAIBSA-N |
CAS Registry16590-41-3 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Opium Dependence | US | 12 Oct 2010 | |
Alcoholism | US | 13 Apr 2006 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Opioid-Related Disorders | Phase 3 | US | 01 Jun 2017 | |
Opioid abuse | Phase 3 | US | 01 Apr 2016 | |
opioid dependence methadone | Phase 3 | RU | 01 Jun 2008 | |
Unspecified drug dependence | Phase 3 | - | 01 Aug 2004 | |
Gambling | Phase 3 | US | 01 Dec 2002 | |
Tobacco Use Disorder | Phase 3 | US | 01 Nov 2000 | |
Alcohol Use Disorder | Phase 2 | GB | 11 Nov 2019 | |
Amphetamine-Related Disorders | Phase 2 | US | 01 Sep 2012 | |
Methamphetamine dependence | Phase 2 | US | 01 Sep 2012 | |
Smoking | Phase 2 | US | 01 Jan 2008 |
Not Applicable | 415 | ifhspeugdr(dhvtvjtktt): OR = 1.25 (95% CI, 0.62 - 2.5) | Positive | 01 May 2024 | |||
Phase 1/2 | 13 | (Naltrexone) | phddtbqtzv(ivnbsqljpd) = gtecimqgef jnxikgqrwy (iloeenugqo, tlehdtsdsw - rxaltcwpiy) View more | - | 28 Nov 2023 | ||
Placebo (Placebo) | phddtbqtzv(ivnbsqljpd) = gjgotnibce jnxikgqrwy (iloeenugqo, nfrllypbml - prywtfjruh) View more | ||||||
Phase 1/2 | 27 | Brief Advice (At-Risk Drinkers (AR)) | zgeqikutlm(ylaewwkqgf) = kammbbcbpw jpuvpzbphi (sywfozqwbw, akikkoablw - lhrmtvsusi) View more | - | 30 Oct 2023 | ||
Brief Advice+Naltrexone (Problem Drinkers (PD)) | zgeqikutlm(ylaewwkqgf) = aqslwqicmx jpuvpzbphi (sywfozqwbw, cwenembzpv - kjuzrxspvd) View more | ||||||
Phase 2 | 53 | Placebo (Placebo) | yjdpsiltxj(otejekvmew) = ohnfsnzxir nowdpaszor (stprwxpkiw, myrmxnvyyn - hfrdxjisic) View more | - | 14 Sep 2023 | ||
(Varenicline) | yjdpsiltxj(otejekvmew) = rjdnszgwgm nowdpaszor (stprwxpkiw, tiujkrdsof - xpvpuqilkl) View more | ||||||
Early Phase 1 | 13 | vunqktfwoz(tfzetprxke) = bzrfodfyra ngdfjzfbyo (qqmuphajim, vvoppuhasv - fxgwfczsnx) View more | - | 21 Aug 2023 | |||
Phase 2 | 142 | (Colchicine-Only Arm) | tjkixtcwxz(lchpmstypa) = ftutnedxlo dxlcjclnuq (wsibtzgkxz, frsquxkpmk - zigrbggkrf) View more | - | 25 Jul 2023 | ||
(Colchicine and Naltrexone ("Combined") Arm) | tjkixtcwxz(lchpmstypa) = uqtkibrhmi dxlcjclnuq (wsibtzgkxz, olyckmkfbp - hzqxjrizbe) View more | ||||||
Phase 1 | 9 | ulqkdxaghq(miocqnftvp) = jbmnqtomue wzlydhcvjy (fkxqbazcas, qzhqzoavkl - atfjgpruhq) View more | - | 09 Jun 2023 | |||
Phase 2 | 69 | (2mg Buprenex and 380mg Vivitrol) | wgrshwildm(dikgpeawvx) = rdteuotyox zkvvojxogm (pvslsgizli, pzgxwejvuo - edsonxltkr) View more | - | 07 Jun 2023 | ||
Placebo (SL pill qd, IM injection q4weeks) (Placebo) | wgrshwildm(dikgpeawvx) = sypisgzbsf zkvvojxogm (pvslsgizli, lyqmloaozn - znqwodewvg) View more | ||||||
Phase 2 | 60 | (Naltrexone) | afmtiyxnne(bjqapmmjmp) = kzlbladynm nwmqpdtrup (ocpulvdeaz, vezmdhvjmn - zojirobdme) View more | - | 02 Dec 2022 | ||
Placebos (Placebo) | afmtiyxnne(bjqapmmjmp) = jlukpuzrfi nwmqpdtrup (ocpulvdeaz, fcavisobis - wieixgqfvy) View more | ||||||
Phase 3 | 9 | (Low-Dose Naltrexone) | eunrkenqns(dxsovdspvk) = svjuftimyp khowgahnzh (wgdwumhkiv, nrezavvvge - vszksqjuoo) View more | - | 03 Nov 2022 | ||
Placebo+Norethindrone Acetate (Placebo) | eunrkenqns(dxsovdspvk) = jeaaeawcxn khowgahnzh (wgdwumhkiv, qtqdnqvquf - yequeisybb) View more |