A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study (Part A) with a 40 Week Open-Label Extension (Part B) Evaluating the Efficacy and Safety of Oral MM120 Compared to Placebo in the Treatment of Adults with Generalized Anxiety Disorder - Panorama

Generalized Anxiety Disorder (GAD)

Double-blind Period (Part A): Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12.

Double-blind Period (Part A): Change from Baseline in HAM-A total score at Week 8, Week 4, Week 2, and Week 1. HAM-A response/remission at each timepoint assessed during 12-week double-blind period. A full description of this endpoint can be found in the protocol., Double-blind Period (Part A): Change from Baseline in the Changes in CSFQ-14 total score at each timepoint assessed during the double-blind period. Percent of men and women with normal and abnormal sexual functioning at each timepoint assessed during the double-blind period., Open-label Extension (Part B): Percent of participants requiring 1, 2, 3, 4, or 5 doses of MM120 during the 52-week study as assessed by participants meeting protocol-specified retreatment criteria during the 40-week open-label period. . A full description of this endpoint can be found in the protocol., Open label extension (Part B): Change from Double-blind Baseline at each timepoint assessed during the 40-week open-label period in the following: • HAM-A/ MADRS total score • CGI-S/ PGI-S Scale score • WPAI • EQ-5D-5L., Open label extension (Part B): CSFQ-14 total score at each timepoint assessed during the open-label period. Percent of men and women with normal and abnormal sexual functioning at each timepoint assessed during the open-label period., Double-blind Period (Part A) key secondary: Change from Baseline to Week 1 in HAM-A total score, to Week 12 in CGI-S scale score, to Day 2 in CGI-S score. Time to first retreatment or lack of efficacy

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