Supernus Pharmaceuticals, Inc. today announced that its Phase IIa U.S. clinical trial of SPN-812 in adults for the treatment of attention deficit hyperactivity disorder (ADHD) met the primary endpoints of safety and tolerability, and showed statistically significant median reduction versus placebo in both investigator-rated and patient-rated ADHD symptom scores. The trial was a randomized, double-blind, placebo-controlled trial in 52 adults with a current diagnosis of ADHD (26 subjects per treatment group).
“Because this proof-of-concept study was not designed to show a definitive statistical significant separation from placebo on the primary efficacy outcome, we are extremely pleased to have observed such a strong signal in such a small study”
"We are very excited about these positive results as we advance our second ADHD portfolio product candidate in development and continue to make steady progress across all of our pipeline product candidates," said Jack Khattar, Supernus president and CEO. "About 13 million Americans are estimated to suffer from ADHD, and about 30% of patients do not adequately respond to or cannot tolerate stimulant ADHD treatments. The pharmacological profile of SPN-812 is promising for the treatment of ADHD and could represent an alternative to existing ADHD regimens in the United States."
Patients in the active arm were administered SPN-812 at a single dose level three times a day over five weeks, after a one-week titration phase. The primary endpoint was safety, and SPN-812 was shown to be safe and well tolerated by patients. The secondary endpoints included: the efficacy of SPN-812 as measured by Total ADHD Symptom Score on the Conners' Adult ADHD Rating Scale, or CAARS, a commonly-used measurement for ADHD in adults, as rated by each of the investigators and the patients; and the effectiveness of SPN-812 when compared to placebo as determined by changes in the Clinical Global Impressions— Improvement, or CGI-I, score. Subjects in the active group achieved overall significant median reductions from baseline in investigator-rated CAARS total ADHD symptom scores by study end, -11.5 points vs. -6.0 for placebo>
"Because this proof-of-concept study was not designed to show a definitive statistical significant separation from placebo on the primary efficacy outcome, we are extremely pleased to have observed such a strong signal in such a small study," said Paolo Baroldi, senior vice president and chief medical officer of Supernus. "The results are also encouraging because we used an immediate-release formulation in the study, which we believe to be less than optimal when compared to an extended-release formulation. With an extended-release formulation of SPN-812, we believe we could achieve a much better release profile and therefore optimize this clinical outcome."
SPN-812 is the company's second ADHD-related program. Supernus is also developing SPN-810 (molindone hydrochloride), a novel treatment for impulsive aggression in patients with ADHD. In 2010, Supernus reported positive results from the Phase IIa trial of SPN-810, its investigational candidate for treatment of children with ADHD and persistent serious conduct problems. SPN-810 met the primary endpoints of safety and tolerability, and showed statistically significant reduction versus baseline in serious persistent conduct problems across all doses. The company is currently planning to initiate a phase IIb trial for SPN-810.
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