France approves compassionate use scheme for generic ketamine in suicidal crisis
Last month, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced its decision to establish compassionate access to generic ketamine for patients in suicidal crisis.
The approval concerns the administration of intravenous (IV) racemic ketamine to adults experiencing acute suicidal ideation. The protocol requires prescription by psychiatrists, with administration taking place in hospital settings, and does not exclude based on psychiatric comorbidities. The Compassionate Use Programme will run for three years, followed by a re-evaluation of the data.
The decision is based on scientific evidence demonstrating the effectiveness of racemic IV ketamine in this indication, the lack of adequate alternative treatments, and the comparatively lower cost of generic ketamine in relation to esketamine.
From a European perspective, France joins countries such as Norway and Germany in, respectively, expanding access to generic ketamine for psychiatric indications and in establishing compassionate use frameworks for compounds with psychedelic effects.
