Drug Profile
Buprenorphine/samidorphan - Alkermes
Alternative Names: ALKS 33-BUP; ALKS 33/buprenorphine; ALKS-5461; BUP-ALKS 33; Buprenorphine/ALKS-33; Buprenorphine/RDC 0313; RDC 0313/buprenorphine; Samidorphan/buprenorphineLatest Information Update: 24 Sep 2021
Price :
$50
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At a glance
- Originator Alkermes
- Developer Alkermes plc
- Class Amides; Antidepressants; Cyclopropanes; Drug withdrawal therapies; Morphinans; Opioid analgesics; Small molecules
- Mechanism of Action Nociceptin receptor agonists; Opioid delta receptor antagonists; Opioid kappa receptor antagonists; Opioid mu receptor agonists; Opioid mu receptor antagonists
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Preregistration Major depressive disorder
- No development reported Cocaine-related disorders
Most Recent Events
- 24 Sep 2021 Buprenorphine/samidorphan is still in preregistration for Major depressive disorder (Adjunctive treatment, In adults, In the elderly, Treatment-experienced) in USA
- 24 Sep 2021 No development reported - Phase-III for Major depressive disorder (Adjunctive treatment) in Australia, Bulgaria, Canada, Puerto Rico, Germany, Poland, Slovakia, Hungary (Sublingual)
- 19 May 2020 Alkermes terminates a phase III trial in Major depressive disorder in USA, Australia and Puerto Rico (sublingual) due to sponsor's decision (NCT03610048)