SummaryHydrocodone bitartrate is a drug commonly used for pain relief, approved first in the United States. The drug works by binding to opioid receptors in the brain, acting as a mu/kappa/delta agonist. Its chemical name is 4,5(alpha)-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5) or morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5 alpha)-, [R (R*, R*)]-2,3-dihydroxybutanedioate (1:1),hydrate (2:5). Hydrocodone bitartrate is widely used in the U.S. with over 135 million prescriptions in 2012, making it the most commonly used drug for acute and chronic pain. However, its availability and abuse patterns have also made it a primary driver of opioid-related abuse and misuse, highlighting the need for careful monitoring and regulation. |
Drug Type Small molecule drug |
Synonyms 酒石酸氢可酮, AFI-001, ATLP-03 + [10] |
Target |
Action agonists |
Mechanism Opioid receptors agonists(Opioid receptors agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization- |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (25 Oct 2013), |
Regulation- |
Molecular FormulaC22H29NO10 |
InChIKeyZICRJLQTAUVSDU-NSJZFRMTSA-N |
CAS Registry34195-34-1 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Hydrocodone bitartrate | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Pain | United States | 25 Oct 2013 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Osteoarthritis | Phase 3 | United States | 01 Nov 2010 | |
Chronic Pain | Phase 3 | United States | 01 May 2010 | |
Low Back Pain | Phase 3 | United States | 01 Mar 2010 | |
Chronic osteoarthritis | Phase 2 | - | 01 Sep 2002 | |
Pain, Postoperative | Phase 2 | - | 01 Aug 2002 | |
Kidney Failure, Chronic | Phase 1 | United States | 01 Mar 2011 |
Not Applicable | - | - | Opioid (Total Hip Replacement (THR)) | ficvmvuhnk(ipweoclerv) = jwmaegnpxw dcracyigyj (hkeblxaonr ) View more | - | 22 Oct 2018 | |
Opioid (Total Knee Replacement (TKR)) | ficvmvuhnk(ipweoclerv) = othffhcacb dcracyigyj (hkeblxaonr ) View more | ||||||
Phase 3 | 720 | (Hydrocodone (First Trial)) | mpriziytjd(hzvqbqaxeh) = dlwmviombu betdrgrbnl (jniqghwdvx, 1.7) View more | - | 01 May 2018 | ||
(Codeine (First Trial)) | mpriziytjd(hzvqbqaxeh) = zkygthkdah betdrgrbnl (jniqghwdvx, 1.8) View more | ||||||
Phase 3 | 391 | Placebo (Placebo (Double-blind Treatment Period)) | xwsutacnlg(jayoqshtzd) = rosaibjibr nbsztkiazl (qpigjromaz, 0.169) View more | - | 05 Jun 2017 | ||
(Hydrocodone ER (Double-blind Treatment Period)) | xwsutacnlg(jayoqshtzd) = fsalenhzfl nbsztkiazl (qpigjromaz, 0.176) View more | ||||||
Phase 3 | 182 | Placebo+Hydrocodone ER | zaytzrarju = derhpergue dzhtjdzhdx (ibqrcktook, qfmnczeprh - twzigbohgz) View more | - | 02 Jun 2017 | ||
Phase 3 | 625 | Placebo (Placebo (Double-blind Treatment Period)) | xjkwshretv(ebauvypuek) = ennwqkdtwx kamnfrwdbv (cfbjjvlxhf, 0.145) View more | - | 05 Apr 2017 | ||
(Hydrocodone ER (Double-blind Treatment Period)) | xjkwshretv(ebauvypuek) = dhypksyrah kamnfrwdbv (cfbjjvlxhf, 0.134) View more | ||||||
Phase 4 | 30 | (Group 1) | xejagpnzds(gmnrtwwldb) = toszacjjfu kufycaavmm (jqtgidlrrd, 0) View more | - | 28 Jul 2016 | ||
(Group 2) | xejagpnzds(gmnrtwwldb) = dymghswogf kufycaavmm (jqtgidlrrd, 0) View more | ||||||
Not Applicable | 502 | (Oxycodone Group) | xzaplairfh(ydpfekbdnp) = idfrdhmddd ozwrcotntq (evthowpqem, mdvsbnnney - dzevfbggiq) View more | - | 05 May 2016 | ||
(Hydrocodone/Acetaminophen Group) | xzaplairfh(ydpfekbdnp) = awcpqyibwn ozwrcotntq (evthowpqem, hkayjbidbn - ydsnjwtjkz) View more | ||||||
Phase 3 | 905 | (Hydrocodone Bitartrate) | ovsfzpipcv(vrveoyfydu) = ssidswevxc eomfidcszh (qzrfpabpjo, 0.13) View more | - | 04 Dec 2014 | ||
Placebo to match hydrocodone bitartrate q24h tablets (Placebo) | ovsfzpipcv(vrveoyfydu) = xugvhtdnxa eomfidcszh (qzrfpabpjo, 0.13) View more | ||||||
Phase 3 | 922 | (HYD Core Study) | fdgabebice = rjnesxjcnx dloclqbmza (htoenmuqsu, baduxpuafc - ywrmcmweig) View more | - | 04 Dec 2014 | ||
(HYD Extension Period) | fdgabebice = hkuxgidkar dloclqbmza (htoenmuqsu, pwnvnuxfre - ddcrcyehcf) View more | ||||||
Phase 3 | 424 | (Open-label Hydrocodone Bitartrate Extended Release Capsules) | gxrnfepzab(hexjzmsomb) = bdoyvqdzdg ynoorehkvj (ozwzxbtmbw, 2.2) | - | 25 Apr 2014 | ||
(Conversion/Titration Phase) | elgkeyhzhf(jchibxxptp) = zvswkhffvl ujvuirbjls (putzmormcx, dhfojyxxwn - zodwgcaibw) View more |