 Buprenorphine (top) + samidorphan (bottom) | |
| Combination of | |
|---|---|
| Buprenorphine | Opioid modulator |
| Samidorphan | Opioid antagonist |
| Clinical data | |
| Other names | ALKS-5461 |
| Routes of administration | Sublingual[1] |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
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).[2]
ALKS-5461 failed to meet its primary efficacy endpoints in two trials from 2016.[3] On the basis of a third study that did meet its primary endpoints, Alkermes initiated a rolling New Drug Application with the FDA.[4]
In November 2018, an FDA panel voted against recommending approval, finding that evidence was insufficient.[5] As such, approval of the medication was rejected in 2019.[6] It is a κ-opioid receptor (KOR) antagonist and is being developed by Alkermes.
- ^ Dhir A (January 2017). "Investigational drugs for treating major depressive disorder". Expert Opinion on Investigational Drugs. 26 (1): 9–24. doi:10.1080/13543784.2017.1267727. PMID 27960559. S2CID 45232796.
- ^ Machado-Vieira R, Henter ID, Zarate CA (May 2017). "New targets for rapid antidepressant action". Progress in Neurobiology. 152: 21–37. doi:10.1016/j.pneurobio.2015.12.001. PMC 4919246. PMID 26724279.
- ^ Steele A (21 January 2016). "Alkermes Depression Drug Disappoints in Trials". WSJ. Retrieved 21 January 2016.
- ^ Cite error: The named reference
Fiercethirdwas invoked but never defined (see the help page). - ^ Cite error: The named reference
FierceBiotech2018was invoked but never defined (see the help page). - ^ "FDA declines to approve Alkermes opioid-based depression drug". Reuters. 1 February 2019. Retrieved 4 February 2019.