Shire ‘reaches new milestone for ADHD drug’

Shire, the UK’s third-largest pharmaceutical company, has claimed that the development of its investigational compound for the treatment of attention deficit/hyperactivity disorder (ADHD) has reached a new milestone.

The company describes SPD465 as the “first and only” ADHD stimulant product to control inattention, hyperactivity and impulsivity for up to 16 hours. The active ingredient in SPD465 is the same as in its best-selling drug, Adderall XR, but it has been formulated to be effective over the course of 16 hours.

Now the company has announced it has filed the drug with the FDA – a move described by Shire as an important development that could precede EU and UK approval.

Matthew Emmens, Shire’s chief executive officer, remarked: “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,” he added.

In related news, the Independent has said that Shire is expected to receive regulatory approval from the US for Elaprase, a treatment for the rare genetic disorder, Hunters syndrome.

The paper claims that the drug could become one of the company’s biggest sellers, potentially generating revenues of up to 164 million pounds, making it Shire’s second best-selling drug behind Adderall XR.

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