Shire's once-daily treatment for attention-deficit hyperactivity disorder (ADHD) - Intuniv - has now been launched in the UK for children aged between 6 and 17.
Intuniv (guanfacine) was approved by the European Commission last year as a therapy for ADHD in children who cannot tolerate or do not respond to conventional stimulant-based therapies such as amphetamine-based drugs.
The drug is a once-daily selective 2A adrenergic receptor agonist and is the first drug in that class to be licensed for ADHD in the EU. It has been launched in the UK with a list price of £56 to £76 per month, depending on the dose needed.
It is also the first alternative to Eli Lilly's non-stimulant ADHD therapy Strattera (atomoxetine) in Europe, providing another option for the approximately 10% of people with the condition who are not candidates for stimulant therapy.
Preclinical studies suggest that the drug may exert physiological effects by selectively stimulating the alpha-2A adrenergic receptor in the prefrontal cortex, a region of the brain known to control several cognitive functions including attention and social behaviours.
Intuniv has also been launched in Germany and Denmark and additional EU launches are planned over the coming year, according to Shire. In the UK, ADHD is estimated to affect 3%-9% of school-age children and young people.
"The availability of the new non-stimulant, guanfacine prolonged release tablets, may represent an important alternative treatment option, enabling physicians to tailor ADHD therapy to those patients for whom stimulants are not suitable," said Chris Steer, a consultant paediatrician with NHS Fife.
Intuniv was approved in the US several years ago and has been a big product in Shire's ADHD franchise, although it has latterly been affected by generic competition in the US market after losing patent protection there in December 2014. Sales plummeted 80% to just $65m last year.
Shire has been rolling it out in different international markets to try to stem the loss in revenue, and is also planning a launch in Japan in the coming months.
While Intuniv remains an important ADHD product for Shire, the company's main near-term ambition in the category is securing approval for SHP465, a mixed amphetamine salt product that it believes could expand the use of drug therapy for ADHD in adults.