Medice receives first German authorisation for treatment of adult ADHD

Iserlohn, April 2011 – Since 15 April 2011, Medikinet® adult has been authorised as the first and only drug in Germany containing the active ingredient methylphenidate for the treatment of adults with Attention Deficit Hyperactivity Disorder (ADHD). Medikinet® adult is planned to be available from summer 2011. This will close a long-standing gap in German healthcare for adult ADHD patients.

In Germany, around four to six percent of children and adolescents between the ages of six and 18 are affected by ADHD. In more than half of these cases, the disorder persists into adulthood – corresponding to around 250,000 adult ADHD patients. Extended-release methylphenidate – the medicinal criterion standard when it comes to the treatment of ADHD in children and adolescents – shall now also be available to adults in the form of Medikinet® adult. "With the inclusion of adult treatment, Medice continues to uphold its therapeutic competence long since established in treating children and adolescents with ADHD", Managing Director Dr Katja Pütter-Ammer comments on the milestone in the treatment of those affected.

Medikinet® adult is indicated for the treatment of patients from the age of 18, who have been affected by ADHD since childhood, if other forms of treatment alone have proven to be insufficient. "Clinical research has shown that the established multi-modal approach of behavioural therapy, psychosocial care and medicinal treatment used on children and adolescents is also considered to be the most promising method for adults", explains Managing Director Dr Richard Ammer with regards to the clinical approach. "This was confirmed by the EMMA study, which initiated the clinical authorisation of Medikinet® adult in 2003." EMMA (Erwachsene mit MPH bei ADHS - “adults with methylphenidate to treat ADHD”), the multi-centre, randomised, placebo-controlled phase III study [1], which included 363 adult ADHD patients, was able to show that extended-release methylphenidate is effective and tolerated over a period of six months and presents a significant additional advantage to psychotherapy. Based on the former study, a confirmatory phase III study was conducted [2] which included 162 patients over two months and documented the significantly improved response of extended-release methylphenidate versus placebo within psychopathological and functional efficacy parameters.

Other drugs currently authorised in Germany containing the active ingredient methylphenidate (such as Concerta®, Ritalin LA®, Equasym® extended-release, Medikinet®, Medikinet® extended-release, etc.) continue to be restricted to the treatment of children and adolescents and will not be reimbursed through statutory health insurance when used by adults within the framework of off-label treatment.

Literature
[1] Rösler M et al. Eur Arch Psychiatry Clin Neurosci 2009; 259(2): 120-129
[2] Retz W et al.  World J Biol Psychiatry 2010; Dec 14 [Epub ahead of print]