Drug Overview
ALKS 5461 (Alkermes) is a fixed-dose combination of buprenorphine, a mu opioid receptor partial agonist and kappa opioid receptor antagonist, and samidorphan (ALKS 33), which is a proprietary opioid modulator. Buprenorphine is more commonly known as an analgesic in low doses and as an anti-addiction drug in high doses, but has also been demonstrated to have an antidepressant effect. The combination with samidorphan is hypothesized to allow for buprenorphine’s antidepressant effect through kappa opioid receptor antagonism, while samidorphan blocks any activity at mu opioid receptors. The net effect of the combination is selective kappa opioid receptor antagonism.
The drug's positive data are currently limited to one Phase III trial and one Phase II trial, which falls short of the two adequate and well-controlled clinical trials required for US Food and Drug Administration (FDA) approval. Despite its receipt of a complete response letter, another ongoing Phase III trial may yet secure the drug’s approval. ALKS 5461’s main attractive characteristics are its offering as a new drug class and its potential to address high unmet need by targeting treatment-refractory patients. Although its efficacy data have been modest, key opinion leaders suspect the drug may be suitable for a subpopulation of patients.
Analyst Outlook
ALKS 5461’s ([buprenorphine + samidorphan]; Alkermes) positive data are currently limited to one Phase III trial and one Phase II trial, which falls short of the two adequate and well-controlled clinical trials required for US Food and Drug Administration (FDA) approval. Despite its receipt of a complete response letter, another ongoing Phase III trial may yet secure the drug’s approval. ALKS 5461’s main attractive characteristics are its offering as a new drug class and its potential to address high unmet need by targeting treatment refractory patients. Although its efficacy data have been modest, key opinion leaders suspect the drug may be suitable for a subpopulation of patients.
ALKS 5461 (Alkermes) is a fixed-dose combination of buprenorphine, a mu opioid receptor partial agonist and kappa opioid receptor antagonist, and samidorphan (ALKS 33), which is a proprietary opioid modulator. Buprenorphine is more commonly known as an analgesic in low doses and as an anti-addiction drug in high doses, but has also been demonstrated to have an antidepressant effect. The combination with samidorphan is hypothesized to allow for buprenorphine’s antidepressant effect through kappa opioid receptor antagonism, while samidorphan blocks any activity at mu opioid receptors. The net effect of the combination is selective kappa opioid receptor antagonism.
The drug's positive data are currently limited to one Phase III trial and one Phase II trial, which falls short of the two adequate and well-controlled clinical trials required for US Food and Drug Administration (FDA) approval. Despite its receipt of a complete response letter, another ongoing Phase III trial may yet secure the drug’s approval. ALKS 5461’s main attractive characteristics are its offering as a new drug class and its potential to address high unmet need by targeting treatment-refractory patients. Although its efficacy data have been modest, key opinion leaders suspect the drug may be suitable for a subpopulation of patients.
Analyst Outlook
ALKS 5461’s ([buprenorphine + samidorphan]; Alkermes) positive data are currently limited to one Phase III trial and one Phase II trial, which falls short of the two adequate and well-controlled clinical trials required for US Food and Drug Administration (FDA) approval. Despite its receipt of a complete response letter, another ongoing Phase III trial may yet secure the drug’s approval. ALKS 5461’s main attractive characteristics are its offering as a new drug class and its potential to address high unmet need by targeting treatment refractory patients. Although its efficacy data have been modest, key opinion leaders suspect the drug may be suitable for a subpopulation of patients.
Table of Contents
OVERVIEW
LIST OF FIGURES
LIST OF TABLES
