Drug Overview
ALKS 3831 is an orally available, fixed-dose combination of samidorphan (ALKS 33) and olanzapine being developed by Alkermes. Samidorphan is a novel, potent mu-opioid antagonist, while olanzapine is an atypical antipsychotic with antagonist activity at the dopamine D2 and serotonin 5-HT2A receptors. ALKS 3831 was designed to display olanzapine’s high antipsychotic efficacy, while also benefitting from an improved metabolic profile. The drug is currently in Phase III development in the US, for the treatment of schizophrenia and bipolar disorder.
TABLE OF CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 ALKS 3831 : Bipolar disorder
10 ALKS 3831 : Schizophrenia
LIST OF FIGURES
8 Figure 1: ALKS 3831 for bipolar disorder – SWOT analysis
14 Figure 2: ALKS 3831 for schizophrenia – SWOT analysis
15 Figure 3: Datamonitor Healthcare’s drug assessment summary of ALKS 3831 for schizophrenia
16 Figure 4: Datamonitor Healthcare’s drug assessment summary of ALKS 3831 for schizophrenia
18 Figure 5: ALKS 3831 sales for schizophrenia in the US, 2017–26
LIST OF TABLES
6 Table 1: ALKS 3831 drug profile
7 Table 2: ALKS 3831 Phase III trials in bipolar disorder
11 Table 3: ALKS 3831 drug profile
12 Table 4: ALKS 3831 Phase III data in schizophrenia
14 Table 5: ALKS 3831 Phase III trials in schizophrenia
18 Table 6: ALKS 3831 sales for schizophrenia in the US ($m), 2017–26