Shire plc has reached an agreement with the US Food and Drug Administration (FDA) on a clear regulatory path for SHP465 (triple-bead mixed amphetamine salts - MAS), an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults.

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 pediatric 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’s first patient, first visit to take place 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. This update follows Shire’s announcement on October 9, 2014, that it was engaging the FDA to determine the parameters of clinical data requirements in order to submit the Class 2 resubmission.

“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.

There are patents supporting Shire’s overall ADHD franchise in the U.S. that extend to 2029. With a launch planned for the second half of  2017, Shire expects that SHP465, following FDA approval, will have three years of Hatch-Waxman exclusivity and at least three patents listed in the FDA Orange Book expiring as late as May 2029.

Vyvanse (lisdexamfetamine dimesylate), which has patents expiring in 2023, is a prescription medicine used for the treatment of ADHD in patients 6 years and above and for the treatment of moderate to severe Binge Eating Disorder (B.E.D.) in adults. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity. Shire announced on June 12, 2014 that it has agreed to a Written Request by the FDA to conduct paediatric clinical studies to investigate the potential use of Vyvanse for the treatment of ADHD in preschool-age children, ages 4 to 5. Upon FDA confirmation of a timely submission and review of data that adheres to the requirements of the Written Request, Shire will be entitled to the benefits of the Best Pharmaceuticals for Children Act, including a six-month extension to the exclusivity afforded by Shire’s patents for Vyvanse.

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Vyvanse may harm others and is illegal.

Vyvanse is a prescription medicine currently only approved in the United States, Canada, Australia, several European countries (trade name: Elvanse/Tyvense) and Brazil (trade name: Venvanse) for ADHD and in the United States for the treatment of moderate to severe B.E.D. in adults. Vyvanse should only be used in accordance with locally approved prescribing information.