Buprenorphine/samidorphan
Buprenorphine/samidorphan (developmental code name ALKS-5461) is a combination formulation of buprenorphine and samidorphan which is under development as an add on to antidepressants in treatment-resistant depression (TRD).
Buprenorphine (top) + samidorphan (bottom) | |
| Combination of | |
|---|---|
| Buprenorphine | Opioid modulator |
| Samidorphan | Opioid antagonist |
| Clinical data | |
| Other names | ALKS-5461 |
| Routes of administration | Sublingual |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
ALKS-5461 failed to meet its primary efficacy endpoints in two trials from 2016. On the basis of a third study that did meet its primary endpoints, Alkermes initiated a rolling New Drug Application with the FDA.
In November 2018, an FDA panel voted against recommending approval, finding that evidence was insufficient. As such, approval of the medication was rejected in 2019. It is a κ-opioid receptor (KOR) antagonist and is being developed by Alkermes.
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