Shire plots new ADHD drug approval
pharmafile | April 7, 2015 | News story | Sales and Marketing | ADHD, FDA, SHP465, Shire, Vyvanse, clinical trials, paediatrics
Shire is launching a new clinical trial as part of its FDA submission for a potential ADHD treatment.
The company has agreed with the US regulator to conduct paediatric clinical trials of SHP465, (triple-bead mixed amphetamine salts – MAS), an investigational oral stimulant that is being evaluated as a potential treatment for ADHD in adults.
Shire’s long-term goal is to file – and win – approval for SHP465 as a treatment for adults. The Irish firm has agreed with the regulator to conduct a short-term efficacy and safety study in children and adolescents aged six to 17, which the FDA requested “to better understand the potential effects of SHP465 on children with ADHD in the event of use in this population.”
Adult patients with ADHD represent the fastest growing segment of the ADHD patient population, according to data from IMS Health.
In a statement, Shire says the company anticipates that the clinical trial will begin in August 2015 and end in the last quarter of 2016. Shire then expects to submit SHP465 to the FDA by Q2 2017 and, pending FDA approval, anticipates launching the medicine in the second half of 2017.
“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.
“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 finalise our resubmission plans for this medicine,” says Philip Vickers, Shire’s head of research and development.
Shire already has an established portfolio in ADHD. Vyvanse (lisdexamfetamine dimesylate) is approved for the treatment of ADHD in patients aged six years and above in several countries including the UK (where it is called Elvanse).
Shire has also agreed to an FDA request to conduct paediatric clinical studies of Vyvanse as a treatment for ADHD in preschool-age children aged four and five. If successful, Shire will earn a six-month exclusivity extension, under the terms of the Best Pharmaceuticals for Children Act. The company is also eyeing a possible approval for Vyvanse as a weight-loss treatment.
Lilian Anekwe
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