Shire's long-acting ADHD drug wins U.S. approval

By Natalie Grover

June 20 (Reuters) - The U.S. Food and Drug Administration (FDA) on Tuesday approved Shire Plc (Xetra: S7E.DE - news) 's long-acting therapy for attention deficit hyperactivity disorder (ADHD), adding another treatment to its stock of drugs for the cognitive condition that affects millions of children.

Shire's SHP465 drug, known as Mydayis, contains the same active ingredient as the company's widely used ADHD treatment Adderall XR but is formulated to last up to 16 hours. Dublin-based Shire's Adderall XR, which manages symptoms for up to 12 hours, is available in generic forms.

"It's obviously not a new molecule but it does extend delivery," said Dr. Gregory Mattingly, who has been a study investigator in multiple Shire ADHD-drug trials.

ADHD is characterized by inattention and/or hyperactivity-impulsivity that affects development. Estimates vary but recent data show up to 11 percent of American children are afflicted and more than half continue to suffer from it as adults.

Shire, whose ADHD drugs Adderall XR and Vyvanse generated close to $2.4 billion in sales last year, plans to launch Mydayis in the third quarter of 2017.

Both Mydayis and Adderall XR contain amphetamine, a stimulant that elevates levels of dopamine - a neurotransmitter associated with motivation, attention and movement.

Stimulants carry a risk of abuse, can be poorly tolerated, and even be fatal in rare cases. Non-stimulant ADHD treatments have a cleaner side-effect profile but are typically less effective.

Mydayis is designed to help eliminate the use of short-acting stimulants given to boost the impact of long-acting ones, especially among college students and adults, Mattingly said.

However, the drug cannot be used for children aged 12 years and younger, the company said on Tuesday.

Shire, which sponsored an awareness campaign on ADHD featuring Maroon 5 singer Adam Levine in 2011, first filed an application to market Mydayis in 2006, but faced multiple setbacks, including additional studies to satisfy the FDA.

Other ADHD drug developers include Neos Theraputics Inc , Alcobra Ltd (NasdaqGM: ADHD - news) and Aevi Genomic Medicine (NasdaqGM: GNMX - news) .

Privately held NLS Pharma, which is developing a non-stimulant ADHD treatment, reported positive mid-stage data last month. (http://reut.rs/2rAankA) (Reporting by Natalie Grover in Bengaluru; Editing by Arun Koyyur and Bill Trott)