EMA starts review of ipidacrine-containing medicines

EMA’s human medicines committee (CHMP) has started a review of medicines containing ipidacrine. These medicines have been authorised in several EU countries through national procedures and are used in adults to treat different conditions affecting the nervous system. A company recently submitted an application for a generic formulation of ipidacrine in four EEA countries. In the context of this application, concerns were raised regarding the strength of the data supporting the effectiveness of ipidacrine in its authorised uses. This was because these data mainly came from studies which had several uncertainties. Many of these studies included a small number of participants, did not compare ipidacrine to another medicine or placebo (a dummy treatment), or were designed so that both the participants and investigators conducting the studies were aware of the treatment that was given. In addition, the findings of a study comparing ipidacrine with placebo for the treatment of lumbosacral radiculopathy (a condition where the nerves in the lower back are irritated or compressed) contributed to the uncertainties regarding its effectiveness. Furthermore, medicines containing ipidacrine are authorised for use in a diverse range of neurological conditions, with differing causes and symptoms, which are not clearly defined or aligned with current guidelines issued by medicines regulators. Concerns were also raised regarding the potential for ipidacrine to cause liver damage. This...