Days after Neos Therapeutics (NSDQ:NEOS) nabbed U.S. regulatory approval for its controlled-release formulation of methylphenidate, Shire (NSDQ:SHPG) said it won a nod from the FDA for its long-acting ADHD drug.
The drug, Mydayis, is made up of the same active ingredient in Shire’s ADHD treatment Adderall XR – amphetamine – but it is designed to last up to 16 hours. Adderall XR is formulated to control symptoms in patients for up to 12 hours.
“It’s obviously not a new molecule but it does extend delivery,” study investigator Gregory Mattingly told Reuters.
Shire’s ADHD drugs, Adderall XR and Vyvanse, reportedly brought in nearly $2.4 billion in sales last year.
The company plans to launch the extended-release treatment in the 3rd quarter of this year. Mydayis was designed for patients who usually take 2 doses of ADHD medicines throughout their day.
Shire tried to bring Mydayis to market in 2006, but was asked by the FDA to conduct additional studies.
Neos experienced similar setbacks with its reformulated drug. The company had to resubmit its application for approval from the FDA in December, after the regulatory watchdog asked the company to conduct another study comparing the drug used in clinical trials and the 1 that the company wanted to sell.
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