Evenamide

Table of contents

• What is evenamide?
• How does evenamide work?
• Which conditions is evenamide studied for?
• How is evenamide given?
• What do the clinical trials show?
• What side effects are known?

What is evenamide?

Evenamide is a chemically synthesised substance being developed as an add-on treatment for schizophrenia. It is classified in the therapeutic area of psychiatry and psychology, specifically mental disorders.^[1] The product records list Newron Pharmaceuticals SpA as the authorisation holder and supplier.^[1] Evenamide has no marketing authorisation in these records, which means it is an investigational substance still under study.^[1]

How does evenamide work?

Evenamide is described in the scientific literature as a glutamate modulator.^[3][2] Glutamate is a chemical messenger in the brain. Most available antipsychotics act on monoaminergic systems, but these systems are not always disrupted in schizophrenia. Evenamide is being studied because it targets a different pathway, the glutamate system, which may offer a new approach for people who do not respond adequately to existing antipsychotics.^[2]

Which conditions is evenamide studied for?

• Treatment-resistant schizophrenia (TRS) — a form of schizophrenia in which symptoms continue despite treatment with antipsychotic medicines. The Phase 3 trial studies evenamide in people with TRS who are not responding to their current antipsychotic.^[1]
• Chronic schizophrenia with inadequate response — an earlier Phase 2/3 study tested evenamide in people with chronic schizophrenia who were still symptomatic while taking a second-generation antipsychotic.^[3][2]

How is evenamide given?

Evenamide is given by mouth as capsules.^[1] In the Phase 3 trial, the doses studied are 15 mg twice daily and 30 mg twice daily, compared with placebo.^[1] The earlier Phase 2/3 study used a dose of 30 mg twice daily added to a stable dose of a second-generation antipsychotic.^[3]

What do the clinical trials show?

The registered trial is a Phase 3, interventional study in 612 participants with treatment-resistant schizophrenia.^[1] It compares evenamide 15 mg twice daily and 30 mg twice daily with placebo over 12 weeks, while participants continue their current antipsychotic medication.^[1] The main outcome is the mean change from baseline to week 12 on the PANSS total score, a scale that measures positive, negative and general symptoms of schizophrenia.^[1] Safety is assessed through treatment-emergent adverse events, adverse events leading to discontinuation and serious adverse events.^[1]

An earlier Phase 2/3 study enrolled 291 people with chronic schizophrenia who were inadequately responding to a second-generation antipsychotic.^[3] Participants received evenamide 30 mg twice daily or placebo for 4 weeks, added to their existing antipsychotic. The primary outcome was also the change in PANSS total score.^[3] The published report states that add-on treatment with evenamide was associated with a statistically significant improvement compared with placebo.^[3]

What side effects are known?

The Phase 3 trial collects information on treatment-emergent adverse events, adverse events leading to discontinuation and serious adverse events, but the registry record does not report specific side effect frequencies.^[1] The published Phase 2/3 report describes the trial as evaluating safety and tolerability, but the provided source text does not list individual side effects.^[3][2] No detailed side effect profile is available from the sources provided.