Eli Lilly's Strattera has become the first medicine in the UK to be approved specifically for treatment initiation in adults with attention-deficit hyperactivity disorder (ADHD).
The Medicines and Healthcare products Regulatory Agency (MHRA) has licensed the drug to begin treatment of ADHD in adult patients, but only when pre-existing symptoms during childhood can be confirmed by a third-party.
This marks a new era in the treatment of the condition in the country, as while therapy with Strattera (atomoxetine) could be continued into adulthood, there were no licensed options available to initiate therapy in those who had not received a diagnosis in childhood.
Problems with identifying ADHD can stem from a lack of training and awareness among mental health services and the fact that many of the symptoms of the condition - which is characterised by severe and impairing levels of hyperactivity, impulsivity and inattention, potentially leading to educational and social difficulties - overlap with other common mental health disorders, leading to misdiagnosis.
Aside from the health benefits to patients of a timely diagnosis, evidence suggests there is a high cost burden related to under-treating the condition as this can lead to sick leave, drug abuse, accidents and criminality, according to an article by BioPharm Insight published by the Financial Times last month.
“Around two thirds of children and adolescents with ADHD continue to have symptoms into adulthood, yet many adults who are impaired by ADHD symptoms go undiagnosed or are misdiagnosed for other common mental health disorders, and may be prevented from receiving effective treatments,” noted Professor Philip Asherson, Professor of Clinical and Molecular Psychiatry at King’s College London and President of the UK Adult ADHD Network (UKAAN).
A positive step
And so the extended licence for Strattera, alongside ongoing patient and healthcare professional education around recognition and diagnosis, "represents a positive step towards the provision of effective treatments that reduce symptoms and impairments of ADHD in adults, in line with clinical best practice,” he said.
The MHRA approved the extension of the drug's license - which was originally to treat children aged six years and older and adolescents withe ADHD - on the back of data from 10 clinical trials involving 4,800 patients which, according to Lilly, showed statistically significant and clinically relevant differences in the improvements of symptoms, as well as quality-of-life outcomes, offering stable control throughout the day and over time compared with placebo.