Supernus Pharmaceuticals, Inc. today announced the initiation of a Phase IIa U.S. clinical trial of its product candidate SPN812 for the treatment of ADHD in adults. The trial is a proof-of-concept, randomized, double-blind, placebo-controlled study in healthy adults aged 18 to 64, inclusive, with ADHD. Supernus expects to enroll 50 subjects in the study at 5 sites across the United States. The primary objective is to measure safety and tolerability, with a secondary measure of efficacy in reducing symptoms of ADHD. SPN812 has previously been marketed outside the United States with a good tolerability and safety profile.
"We are excited to advance our second ADHD portfolio product into Phase II as we make steady progress across all of our pipeline products," said Jack Khattar, Supernus president and CEO. "Nearly 10 million American adults are estimated to suffer from ADHD, and about 30% of patients do not adequately respond to or cannot tolerate stimulant ADHD treatments. The mechanism of action of SPN812 appears to be promising as a novel treatment of ADHD and we believe it represents a strong alternative to existing ADHD regimens in the United States."
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