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Orexo AB (ORXOF)
OTHER OTC:ORXOF
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
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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
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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
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Sl Fentanyl
Pain
Phase IV
Terminated
Conversion From Fast Acting Oral Opioids to Abstral®
Mar 14, 2011
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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
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 (ORXOF) have in its pipeline
ORXOF is currently developing the following drugs: Buprenorphine, Bnx Sublingual Tablets, Bnx Sublingual Film, Higher Bioavailability Bnx Sublingual Tablets, Buprenorphine/Naloxone Sublingual Tablets, Buprenorphine. These drug candidates are in various stages of clinical development as the company works toward FDA approval.