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Supernus’ ADHD Drug Hits Phase III Endpoint As Filing Beckons

 
• By Alexandra Shimmings

The first of two Phase III trials of Supernus’ ADHD candidate has hit its endpoints in adolescents. The second is due to report in early 2019, setting the stage for regulatory filings.

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• Source: Shutterstock

Supernus Pharmaceuticals Inc. is looking forward to filing SPN-812, its version of the old antidepressant viloxazine hydrochloride, for the treatment of attention-deficit hyperactivity disorder (ADHD) in the US in the second half of next year after promising data from its first Phase III study in adolescents.

Topline results from the pivotal P302 study of SPN-812 in adolescents show that both daily doses tested, 200 mg and 400 mg, met the primary endpoint with robust statistical significance in improvement in the symptoms of ADHD from baseline to

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