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Shire announces clear regulatory path forward for SHP465, an investigational treatment for adults with ADHD

Posted: 7 April 2015 |

Shire has announced a clear regulatory path for SHP465, an investigational medication being evaluated as a potential treatment for ADHD in adults…

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Shire has announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a clear regulatory path for SHP465, an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults.

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Shire has agreed with the FDA to conduct a short-term efficacy and safety study in paediatric patients with ADHD (ages 6-17). While Shire intends to pursue an adult indication, the FDA is requesting this additional paediatric data to better understand the potential effects of SHP465 on children with ADHD in the event of use in this population.

The Company anticipates the clinical trial to start in August 2015, with study completion targeted by the last quarter of 2016. Shire then expects to submit to the FDA by second quarter 2017 a Class 2 resubmission for approval of SHP465 as a treatment for ADHD in adults, which typically entails a 6-month review. Pending FDA approval, Shire anticipates launching the medicine in the second half of 2017.

Adult patients with ADHD represent the fastest growing segment of the overall ADHD patient population

“We believe SHP465 has the potential to be an important treatment option for adults with ADHD, which is why we worked so diligently with the FDA to determine what additional clinical data would be necessary for Shire to finalize our resubmission plans for this medicine,” said  Philip J. Vickers, Ph.D., Head of Research and Development, Shire. “We’re pleased that we now have a clear regulatory path to bring this investigational medicine forward as a potential treatment option for adults with ADHD.”

Adult patients with ADHD represent the fastest growing segment of the overall ADHD patient population. Data from IMS Health (a global healthcare information and technology firm) suggest that about 10% of adult patients are adding an immediate release medicine to their extended release medicine, most often to gain a longer duration of treatment effect.

SHP465 demonstrated a statistically significant difference versus placebo at 16 hours post dosing, with onset of action starting 4 hours post dosing, as measured by the Permanent Product Measure of Performance (PERMP). Common adverse reactions in SHP465 registration trials (incidence ≥5% and at a rate twice placebo) in adults were: insomnia, decreased appetite, dry mouth, decreased weight, heart rate increased, and dysmenorrhea. These adverse events are generally known to be associated with the use of amphetamine products.

For more information about Shire plc, please visit www.shire.com.

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