Shire plc announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a long-acting, triple-bead, mixed amphetamine salts formulation. SHP465 is being evaluated as a potential once-daily treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). The FDA is expected to provide a decision on or around June 20, 2017, the designated Prescription Drug User Fee Act (PDUFA) action date. Shire resubmitted the NDA for SHP465 in response to the Approvable Letter from the FDA (May 18, 2007) that requested additional clinical studies and classified the response as a Class 2 resubmission with a review goal of six months.
“Our progress with the SHP465 clinical development program underscores Shire’s commitment to supporting the needs of patients living with ADHD in the U.S.,” said Philip Vickers, PhD, Global Head of Research and Development, Shire. “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.”
“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,” said Andrew J. Cutler, MD, Executive Vice President and Chief Medical Officer at Meridien Research and an investigator in the SHP465 clinical trials. “It’s encouraging to see that health care professionals and their patients living with ADHD may have more options available to them.”
The NDA for SHP465 includes data from a database of 16 clinical studies evaluating SHP465 in more than 1,600 subjects, including data resulting from a U.S. FDA request to conduct a short-term efficacy and safety study in pediatric patients with ADHD (aged 6-17). Positive top-line results from that study, SHP465-305, were reported in April 2016. The NDA also includes results from SHP465-306, a short-term efficacy study in adults, for which positive top-line results were announced in June 2016.
In earlier adolescent and adult clinical studies, SHP465 demonstrated a statistically significant difference versus placebo at 16 hours post-dosing, with onset of action starting 2 or 4 hours post-dosing, as measured by the Permanent Product Measure of Performance (PERMP). PERMP is an objective, validated, skill-adjusted math test that measures attention in ADHD. The most common adverse reactions in Phase 3 studies (incidence ≥ 5% and at a rate at least twice placebo) in children, adolescents, and/or adults with ADHD were insomnia, decreased appetite, dry mouth, decreased weight, increased heart rate, anxiety, nausea, upper abdominal pain, irritability and dizziness.
