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Sequel to Popular ADHD Drug Back in FDA's Hands

After a decade in limbo, Shire’s other amphetamine salt combo is back under review.

Shire Pharmaceuticals announced yesterday that the US Food and Drug Administration (FDA) had received their New Drug Application for a drug currently called SHP465 for the treatment of attention-deficit/hyperactivity disorder (ADHD).

The drug is seen as somewhat of a sequel to Shire’s Adderall XR, the extended release version of their wildly successful and controversial Adderall, widely prescribed but often misused off-label. With the same active ingredient, amphetamine salts, SHP465 is designed to last for 16 hours, up from the XR version’s 12.

Shire’s efforts to develop the drug to approval are far from new. A version of it, then called SPD465, was first submitted to the FDA in 2006. Since then, the FDA has repeatedly requested more data, and Shire lost patented exclusivity for both the original Immediate Release and the XR version of Adderall.

The company at one point believed it was on pace to release SHP465 in 2015, but the day never came to pass. This week’s press release announces that “Shire resubmitted the NDA for SHP465 in response to the Approvable Letter from the FDA (May 18, 2007) that requested additional clinical studies and classified the response as a Class 2 resubmission with a review goal of six months.”

The recurring regulatory delays and requests have led to an accumulation of data. The submitted NDA contains results of 16 clinical studies evaluating the drug in over 1,600 patients, including one that tested the drug’s safety in 6-to-17 year olds for the treatment of pediatric ADHD. The company is confident in its performance over placebo in phase 3 studies, while acknowledging that those studies displayed many of the same common side effects of its chemical predecessors.

The FDA’s ruling on the drug is expected sometime in June, 2017, according to the press release.

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