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Orexo AB (ORX) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Buprenorphine, Bnx Sublingual Tablets, Bnx Sublingual Film | Opioid Dependence, On Agonist Therapy | Phase III | Completed | Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults | Jul 19, 2013 | ― |
| Higher Bioavailability Bnx Sublingual Tablets | Opioid Dependence, On Agonist Therapy | Phase IV | Completed | Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence | Jul 09, 2013 | ― |
| Buprenorphine/Naloxone Sublingual Tablets, Buprenorphine | Opioid-Related Disorders, Opiate Dependence | Phase III | Completed | Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence | May 02, 2013 | ― |
| Sl Fentanyl | Pain | Phase IV | Terminated | Conversion From Fast Acting Oral Opioids to Abstral® | Mar 14, 2011 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Buprenorphine, Bnx Sublingual Tablets, Bnx Sublingual Film | Phase III | Opioid Dependence, On Agonist Therapy | Completed | Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults | Jul 19, 2013 | ― |
| Higher Bioavailability Bnx Sublingual Tablets | Phase IV | Opioid Dependence, On Agonist Therapy | Completed | Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence | Jul 09, 2013 | ― |
| Buprenorphine/Naloxone Sublingual Tablets, Buprenorphine | Phase III | Opioid-Related Disorders, Opiate Dependence | Completed | Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence | May 02, 2013 | ― |
| Sl Fentanyl | Phase IV | Pain | Terminated | Conversion From Fast Acting Oral Opioids to Abstral® | Mar 14, 2011 | ― |
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Orexo AB (SE:ORX) have in its pipeline
Orexo AB SE:ORX is currently developing the following drugs: Buprenorphine, Bnx Sublingual Tablets, Bnx Sublingual Film, Higher Bioavailability Bnx Sublingual Tablets, Buprenorphine/Naloxone Sublingual Tablets, Buprenorphine, Sl Fentanyl. These drug candidates are in various stages of clinical development as the company works toward FDA approval.