Zulresso
Author: Stephanie Yip
Publisher: Datamonitor Healthcare
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Drug Overview
Zulresso is SAGE Therapeutics’ proprietary intravenous formulation of brexanolone, which is an allosteric modulator of both synaptic and extra-synaptic GABA-A receptors. Zulresso was also investigated for super-refractory status epilepticus; however, it failed to meet the primary endpoint in its Phase III trial, hence its development for this indication was suspended.
The drug is a much-needed, novel prospect for post-partum depression (PPD) as there are currently no drugs approved for this indication. Impressively, Zulresso has produced potent, rapid-onset effects in PPD patients at 60 hours, and is a first-in-class drug addressing critical unmet need, spurring significant enthusiasm for the drug.
Analyst Outlook
Zulresso (intravenous brexanolone; SAGE Therapeutics) is a much-needed, novel prospect for post-partum depression (PPD) as there are currently no drugs approved for this indication. Impressively, Zulresso has produced potent, rapid-onset effects in PPD patients at 60 hours, and is a first-in-class drug addressing critical unmet need, spurring significant enthusiasm for the drug.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Zulresso : Depression
LIST OF FIGURES
12 Figure 1: Datamonitor Healthcare’s drug assessment summary of Zulresso for depression
13 Figure 2: Datamonitor Healthcare’s drug assessment summary of Zulresso for depression
15 Figure 3: Zulresso sales for depression in the US, 2017–26
LIST OF TABLES
6 Table 1: Zulresso drug profile
8 Table 2: Zulresso pivotal data in post-partum depression
11 Table 3: Zulresso ongoing Phase III trials in post-partum depression
12 Table 4: Zulresso for depression – SWOT analysis
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