Supernus Announces Positive Results from Phase III Study For SPN-812 in Adolescents with ADHD

Supernus Pharmaceuticals (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, announced positive topline results from a pivotal Phase III study of SPN-812 in adolescents (P302) for the treatment of attention deficit hyperactivity disorder (ADHD).

As quoted in the press release:

At daily doses of 200 mg and 400 mg, the trial met the primary endpoint with robust statistical significance in improvement in the symptoms of ADHD from baseline to end of study as measured by the ADHD Rating Scale-5. Both active doses were well tolerated.

The Company expects to announce topline data from the final Phase III trial of SPN-812, study P304 in adolescents, by the end of the first quarter of 2019. The Company expects to submit a New Drug Application for SPN-812 in the second half of 2019, and to launch it, pending U.S. Food and Drug Administration approval, in the second half of 2020.

“These data further reinforce the effectiveness of SPN-812 in patients with ADHD, showing a clinically meaningful reduction in the symptoms of ADHD, with a favorable safety and tolerability profile,” stated Jack Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “We now have positive data proving the efficacy and safety of SPN-812 in all ADHD patient populations; positive Phase III data in children 6-11 years old and adolescents 12-17 years old, and positive Phase IIa data in adults.”

Click here to read the full press release.