Shire eyes adult ADHD drug application in 2016 after encouraging results
Shire plans to resubmit a new drug application in the US for its potential treatment for adult attention-deficit/hyperactivity disorder (ADHD) after efficacy and safety trials produced positive results.
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A four-week trial in 275 adults for SHP465, the name for its triple-bead mixed amphetamine salts (MAS), is an investigational oral stimulant that Shire is developing as a potential treatment for adult ADHD in the US, a therapeutic area that it felt to have a significant need for additional treatment options.
While Shire's Addreall and Adderall XR mixed amphetamine salts products already address the childhood ADHD market and are used as short-acting products by some adult sufferers, the adult form of the disorder has been found to be also be remarkably common, with an estimated prevalence of up to 5%.
The primary efficacy analysis of the study showed that SHP465 at 12.5mg and 37.5mg doses, both administered as a daily morning dose, generated a superior result compared to a placebo on a clinically administered ADHD rating score.
Both doses were also significantly better than placebo on the key secondary efficacy analysis of the 'clinical global impression improvement scale' (CGII) a week-four, which Shire said suggested "a marked clinical improvement in patients’ global functioning".
Shire said it plans to file a Class 2 resubmission of the new drug application (NDA) with the US Food and Drug Administration (FDA) by the end of 2016, putting the program on track for potential US approval in the second half of 2017, it believes.
Shire said adverse events, such as decreased appetite, dry mouth, insomnia, headache, anxiety, irritability and bruxism, were "generally mild to moderate" and no different from previous studies of the treatment and with other amphetamine compounds.
"Shire has been working to fully understand the different needs of adult patients with ADHD so we can help physicians and their patients optimally manage the disorder,” said Shire's head of research and development, Philip Vickers.
“We are excited that SHP465, when taking into account the broader clinical development program and multiple dosing strengths, has the potential to benefit adult patients with ADHD.”
Shire intend for SHP465 to provide 16 hours cover from a single tablet and expect the new formulation to claim three years' additional market exclusivity in the US, extending its patent protection out to 2029.
Chief executive Flemming Ornskov has said the adult ADHD product, as well as other repurposing of ADHD products to treat binge-eating, could eventually double sales of Shire's psychiatric portfolio by 2020.