Irish biotechnology company Shire, through its partner Shionogi, has filed a new drug application (NDA) in Japan seeking approval to manufacture and market its Intuniv medicine for the treatment of adults with attention deficit hyperactivity disorder (ADHD).
Comprising guanfacine as the active substance, Intuniv is a non-stimulant, selective agonist of alpha-2A adrenergic receptor. It is being co-developed and commercialised by Shire and Shionogi.
ADHD is a complex disorder that affects multiple cognitive functions. Last year, the drug secured Japanese regulatory approval for treating ADHD patients aged between six and 17.
Shire Neuroscience vice-president and head of Global Clinical Development Brigitte Robertson said: “This is a key milestone, taking us a step closer to potentially providing INTUNIV to adults in Japan in addition to the approved paediatric indication.
“There remains a significant need for new non-stimulant treatment options for adults being diagnosed with ADHD in Japan.”
The submitted NDA is based on top-line data obtained during a Phase III randomised, double-blind, multi-centre, parallel-group, placebo-controlled clinical trial performed in 201 Japanese adult patients over 12 weeks.
Results showed that the drug met its primary endpoint of superiority in improving ADHD symptoms when compared to placebo. A statistically significant improvement in global functioning was also observed during the trial.
Intuniv additionally resulted in significance at the end of therapy on the secondary efficacy analysis using the Clinical Global Impression-Improvement scale (CGI-I).
During the trial, treatment-emergent adverse events were found to be generally mild-to-moderate in severity and similar to those in prior studies of the drug. The investigators did not report any new or unexpected safety findings.
Shire specialises in drug discovery and development for rare diseases and specialised conditions. It has a diverse pipeline across the fields such as oncology, immunology, hematology and neuroscience.
By working with partners such as Shionogi, its drugs have been approved in 100 countries.