The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.

This study is a multi-center trial consisting of a 12-week open-label treatment period (OLP), followed by a 12-week double-blind, placebo-controlled, randomized withdrawal period (DBRWP). During the OLP, subjects receive open-label AXS-14. Subjects achieving treatment response will be randomized into the DBRWP in a 1:1 ratio to either continue on AXS-14 or switch to placebo for up to 12 weeks or until a loss of therapeutic response occurs.

Inclusion Criteria:

• Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria.
• Male or female, ≥18 years of age.
• Provides written informed consent to participate in the study before conducting any study procedures.

Exclusion Criteria:

• Previous participation in a clinical trial with reboxetine or esreboxetine or currently receiving treatment with reboxetine for any condition.
• Unable to comply with study procedures.
• Medically inappropriate for study participation in the opinion of the investigator.