Supernus Pharmaceuticals Inc on Thursday said its experimental treatment for attention deficit hyperactivity disorder met the main goal of reducing symptoms in affected children from six to 11 years of age in two late-stage studies.
The drug, 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.
Analysts, however, believe that SPN-812 could have a slight advantage if it takes effect quicker and causes fewer side effects.
“Onset of action proved more promising… This feature is important given that slow onset has been a primary complaint of other non-stimulants,” Stifel analyst Annabel Samimy said.
Samimy said though the studies reached statistical significance, the results did not represent a clear standout from Strattera.
Children with ADHD, a common developmental disorder, often have trouble paying attention and controlling compulsive behavior
The two placebo-controlled studies tested three doses of SPN-812 for safety and efficacy in 477 and 313 participants, respectively.
The drug was shown to be safe across all doses, and patients recorded a few adverse reactions such as headache, decreased appetite and fatigue, the company said.
Patients on the treatment showed significant improvement in symptoms such as hyperactivity and lack of attention. In one trial, patients showed statistically significant results as early as a week into treatment on two doses, Supernus said.
Brokerage Mizuho Securities sees promising yields if the treatment gets U.S. Food and Drug Administration’s approval. It says the drug could bring in about $600 million in 2025.
Supernus hopes to file for approval in the second half of 2019, and launch the drug in the second half of 2020.
The trials showed weaker-than-expected efficacy, but the drug is still commercially compelling, Mizuho Securities analyst Irina Koffler said.
Preliminary data from two other late-stage studies evaluating SPN-812 in adolescents are expected by the end of the first quarter of 2019, the company said.