Product Description
Buprenorphine, a partial mu-opoid receptor agonist, has unique pharmacologic properties that distinguish it from methadone and other medications used in the treatment of opioid dependence. It has been shown to be as effective as methadone and is generally safe and well-tolerated. (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2994593/)
Mechanisms of Action: OPRM Agonist,OPRD Antagonist,OPRK Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Sublingual,Transdermal,Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Venezuela | Vietnam
Approved Indications: Pain Unspecified | Substance Abuse Unspecified | Opioid-Related Disorders | Pain Unspecified | Substance Abuse Unspecified | Opioid-Related Disorders | Opioid-Related Disorders
Known Adverse Events: Dizziness | Headache | Erythema | Pruritus | Constipation | Depressive Disorder | Back Pain | Pain Unspecified | Toothache | Hyperhidrosis | Edema | Insomnia
Company: Indivior
Company Location: SLOUGH X0 SL13UH
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Egypt, United States, Unknown Location
Active Clinical Trial Count: 11
Highest Development Phases
Phase 3: Neonatal Abstinence Syndrome|Opioid-Related Disorders|Pregnancy Outcomes|Substance Withdrawal Syndrome
Phase 2: Low Back Pain|Radiculopathy|Sciatica
Phase 1: Pain, Postoperative
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| ED-ENVISION | P3 |
Recruiting |
Opioid-Related Disorders |
2027-04-01 |
|
| NIDA-CTN-0100 | P2 |
Recruiting |
Opioid-Related Disorders |
2026-07-01 |
|
| EXHITENTRE | P3 |
Recruiting |
Opioid-Related Disorders |
2026-01-01 |
|
| MOMs | P3 |
Active, not recruiting |
Opioid-Related Disorders|Pregnancy Outcomes|Neonatal Abstinence Syndrome|Substance Withdrawal Syndrome |
2025-01-31 |