Shire Agrees to FDA Request For Vyvanse Pediatric Clinical Trials In ADHD

Shire plc announced in a press release that it has agreed to the Food and Drug Administration’s (FDAs) written request to conduct pediatric clinical studies on Vyvanse (lisdexamfetamine dimesylate). Vyvanse is approved in the U.S. for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients age 6 and above. The proposed studies are for Vyvanse treatment of ADHD in preschool-age children, ages 4 to 5. Philip Vickers, Ph.D., Head of Research and Development at Shire, said, “Shire is committed to continuing to add to the scientific body of knowledge about ADHD treatment options for patients. Additional efficacy and safety data will help clinicians and parents make informed treatment decisions for preschool-age children with ADHD.”

FDA Action

The FDA requested the studies due to the lack of well-controlled studies of ADHD drugs in preschool children. The FDA issued a Written Request for preschool studies of Vyvanse. Shire is to submit data and information that adheres to the requirements of the Written Request. Upon fulfilling the requirements, Shire will be awarded certain benefits according to the Best Pharmaceuticals for Children Act. Those benefits include a six-month exclusivity extension on Shire’s Vyvanse patents that expire in 2023. The federal agency publishes a list of Written Requests for pediatric studies that identifies active moieties since June 1998.

Vyvanse

Vyvanse is approved for ADHD treatment in the U.S., Canada, Australia, Mexico, Brazil, and some European countries. The drug goes by the trade names Elvanse, Tyvense, and Venvanse. Vyvanse (lisdexamfetamine dimesylate) and other CNS stimulants such as amphetamines and methylphenidate-containing products are risky due to the possibility of abuse and dependence. Vyvanse capsules are currently available in dosage strengths of 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg.

Vyvanse Preschool Studies

Shire states that ADHD in preschool children is estimated between three and five percent. Proving that Vyvanse is helpful in controlling ADHD symptoms in that population would add substantially to Shire’s bottom line, which is already growing due to the 18 percent increase in the first quarter of this year. Shire is designing clinical programs that include pharmacokinetic studies, dosing options, efficacy measurements, safety evaluations, and tolerability studies. The company is establishing a Data Monitoring Committee for patient safety. Trials in the preschool program are expected to start in the beginning of 2015.