This article is more than 5 years old. Information may no longer be current.
FDA receives resubmitted NDA for SHP465 for ADHD
Click Here to Manage Email Alerts
Shire recently announced that the FDA acknowledged receipt of a class 2 resubmission of a New Drug Application for SHP465, a triple-bead mixed amphetamine salts capsule, as a once-daily treatment for ADHD.
“Our progress with the SHP465 clinical development program underscores Shire’s commitment to supporting the needs of patients living with ADHD in the US,” Philip Vickers, PhD, global head of research and development at Shire, said in a press release. “Since our first submission, our understanding of ADHD and adult patients’ needs has evolved, and we believe the additional studies in our filing fulfill the request from the FDA. With the potential of once-daily dosing, SHP465, if approved, could help patients address the ongoing challenges of ADHD symptoms.”
Shire resubmitted the NDA in response to an approvable letter from the FDA in May 2007 that requested additional clinical studies and set a review goal of 6 months.
The application included data from 16 clinical studies among approximately 1,600 individuals and data from a short-term efficacy and safety study among children aged 6 to 17 years that the FDA requested.
The NDA also included positive results for SHP465 in adults.
Shire expects a decision from the FDA on June 20, 2017.
“As the medical community broadens its understanding of ADHD and the ways it impacts people differently, it is important to expand the long-acting treatment options available to health care professionals to address patient needs,” study researcher Andrew J. Cutler, MD, executive vice president and chief medical officer at Meridien Research, said in the release. “It’s encouraging to see that health care professionals and their patients living with ADHD may have more options available to them.”