(Reuters) – Supernus Pharmaceuticals Inc said on Thursday its drug for attention deficit hyperactivity disorder met the main goal in a late-stage trial on adolescents, weeks after results from trials testing the drug on children failed to impress investors.
At daily doses of 200 mg and 400 mg, the drug, SPN-812, showed statistical significance in improvement in the symptoms of ADHD among 12-17 years olds, Supernus said.
The drug had also met the main goal in two other late-stage studies testing the drug in children, the company said earlier this month, but its shares had then dropped 16 percent with analysts saying it failed to stand out from existing treatment options for ADHD.
“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,” Chief Executive Officer Jack Khattar said in a statement.
SPN-812 is a non-stimulant and belongs to the same class of medicine as Eli Lilly and Co’s Strattera and Shire Plc’s Intuniv.
The company said it expects to announce data from the final late-stage trial of SPN-812 by the end of the first quarter of 2019, and submit a marketing application to the U.S. health regulator in the second half of 2019.
Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Sriraj Kalluvila and Saumyadeb Chakrabarty