Adults with attention deficit hyperactivity disorder (ADHD) can now be offered a treatment specifically licensed for their condition after the Medicines & Healthcare Products Regulatory Agency (MHRA) authorised the use of Strattera (atomoxetine).
About 1.7 million adults are estimated to have ADHD in the UK. ADHD can have a serious impact on social and functional performance in adults, affecting family and social relationships, work and psychological health.
Continuing treatment from childhood
Until now, adults with ADHD could only receive medication if they were continuing treatment from childhood. Strattera, manufactured by pharmaceutical company Lilly, is the first treatment to receive a licence to initiate treatment of ADHD in adults. It will be available by prescription only.
The new authorisation is in addition to Strattera's current licence to treat children aged six years and older and adolescents.
Undiagnosed ADHD in adulthood
Professor Philip Asherson, president of the UK Adult ADHD Network (UKAAN) said: "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.
"Awareness and knowledge about ADHD in adults is rapidly increasing among healthcare professionals and the extended licence for atomoxetine represents a positive step towards the provision of effective treatments that reduce symptoms and impairments of ADHD in adults."
Significant source of impairment
ADHD in adults represents a significant source of impairment across many areas of life, with research by Lilly showing that 75% having experienced educational difficulties, 83% suffering an adverse effect on their professional life and 24% having difficulties with social relationships.
Equally, comorbid alcohol and substance use disorders, including smoking, are more likely to occur in adults with ADHD.
"There is a need for greater understanding of a condition most people mistakenly believe only affects children. ADHD has a profound effect on the ability to gain and sustain employment, to maintain good relationships at home and at work”, added Andrea Bilbow, chief executive of the National Attention Deficit Disorder Information and Support Service.
Clinically relevant improvements in ADHD symptoms
The new adult licence has been awarded based on the results of 10 clinical trials with atomoxetine in 4,800 patients.
Clinical trials showed statistically significant and clinically relevant differences in the improvements of ADHD symptoms, as well as quality-of-life outcomes, providing stable control throughout the day and over time compared with placebo. Side effects may include decreased appetite, insomnia, headaches, dry mouth, nausea and raised blood pressure and heart rate.
On the basis of the UK licence, Lilly will seek further marketing authorisations in other European countries in line with the EU mutual recognition procedure. Atomoxetine has already been approved for adult use in countries including the USA and Japan.