New Shire ADHD treatment gets FDA green light

Shire announced on Wednesday that the US Food and Drug Administration (FDA) approved Mydayis - mixed salts of a single-entity amphetamine product - as a once-daily treatment comprised of three different types of drug-releasing beads for patients 13 years and older with attention deficit hyperactivity disorder (ADHD).

The FTSE 100 company said it expected to make Mydayis commercially available in the United States in the third quarter of 2017.

Its board said the FDA approval of Mydayis was based on results from 16 clinical studies evaluating Mydayis in more than 1,600 subjects, including adolescents aged 13 to 17 years and adults with ADHD.

In pivotal, placebo-controlled clinical studies, Mydayis “significantly improved” symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents.

Improvement on the PERMP, which Shire described as “an objective, validated, skill-adjusted math test” that measures attention in ADHD patients, reached statistical significance beginning at two or four hours post-dose and lasting up to 16 hours post-dose.

“Mydayis is the latest innovation in Shire’s 20-year legacy of helping to support the treatment of ADHD,” said Shire CEO Flemming Ornskov.

“It’s a testament to Shire’s commitment to helping support the evolving needs of appropriate patients with ADHD.”

Dr Ornskov said with the approval, Shire hoped to help patients who needed a once-daily treatment option.

“Mydayis has shown efficacy lasting up to 16 hours after taking one capsule, beginning at 2 or 4 hours post-dose.”

Andrew J. Cutler, executive vice president and chief medical officer at Meridien Research and an investigator in the Mydayis clinical trials, said many of his patients living with ADHD were trying to manage symptoms that impacted them in different settings - often across home life, school or work, and in social settings.

“Patients have individual needs and may respond differently to treatments, so it is important for healthcare professionals to have multiple options.

“It’s rewarding to work with Shire to provide a new treatment option that may help appropriate patients with ADHD.”