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Low Dose ALKS 5461
ALKS 5461 is a combination of buprenorphine and samidorphan that acts as a partial mu-opioid receptor agonist while blocking opioid-induced side effects through opioid antagonism.
ALKS 5461 is a combination of buprenorphine and samidorphan that acts as a partial mu-opioid receptor agonist while blocking opioid-induced side effects through opioid antagonism. Used for Moderate to severe acute pain, Chronic pain management.
At a glance
| Generic name | Low Dose ALKS 5461 |
|---|---|
| Also known as | ALKS 5461 |
| Sponsor | Alkermes, Inc. |
| Drug class | Opioid agonist-antagonist combination |
| Target | Mu-opioid receptor (buprenorphine component); opioid receptor antagonism (samidorphan component) |
| Modality | Small molecule |
| Therapeutic area | Pain Management / Opioid Use Disorder |
| Phase | Phase 3 |
Mechanism of action
ALKS 5461 combines buprenorphine, a partial mu-opioid receptor agonist used for pain and opioid use disorder, with samidorphan, an opioid antagonist. The samidorphan component is designed to mitigate certain opioid-related adverse effects such as respiratory depression and abuse potential while maintaining the therapeutic benefits of buprenorphine. At low doses, this combination aims to provide analgesia with an improved safety profile.
Approved indications
- Moderate to severe acute pain
- Chronic pain management
Common side effects
- Nausea
- Dizziness
- Headache
- Constipation
- Vomiting
Key clinical trials
- A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study (PHASE3)
- A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Low Dose ALKS 5461 CI brief — competitive landscape report
- Low Dose ALKS 5461 updates RSS · CI watch RSS
- Alkermes, Inc. portfolio CI