Shire files New Drug Application for adult ADHD treatment

By Elaine Rigoli

Tampa, Fla., July 21 - Shire plc has submitted a New Drug Application to the Food and Drug Administration for SPD465, an investigational amphetamine compound for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults.

The application is subject to a 12-month FDA review period.

The company said SPD465 has the same active ingredient as Adderall XR (mixed salts of a single-entity amphetamine product), but is designed to provide ADHD symptom control for up to 16 hours.

"The FDA filing for SPD465 is another milestone met and underscores Shire's commitment to be the market leader in ADHD treatments by offering patients new solutions to manage this chronic disorder. If approved, the 16-hour formulation of SPD465 would make it the longest-acting stimulant medication for adult patients with ADHD, while also providing the efficacy of Adderall XR, the most prescribed brand of ADHD treatment," chief executive officer Matthew Emmens said in a news release.

London-based Shire is a pharmaceutical company that focuses on meeting the needs of the specialist physician.

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