Supernus Pharmaceuticals Inc (NASDAQ: SUPN) reported that SPN-812 exhibited positive topline results in its Phase III study for the treatment of attention deficit hyperactivity disorder.
The Rockville, Md.-based pharmaceutical company, fsed on developing and commercializing products for the treatment of central nervous system diseases, today announced positive topline results from a Phase III study of SPN-812 in adults (P306) for the treatment of attention deficit hyperactivity disorder (ADHD).
At a daily dose of up to 600mg, the trial met the primary endpoint with robust statistical significance (p=0.0040) compared to placebo in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating Scale (AISRS).
In addition to meeting the primary efficacy endpoint, the Phase III study met the key secondary efficacy endpoint with statistical significance (p=0.0023) in the change from baseline of the Clinical Global Impression – Severity of Illness (CGI-S) Scale at week Six. The active dose was well tolerated.
Said CEO Jack Khattar, "These compelling data in adults will be important for our planned sNDA submission to make this treatment option available, if approved by the FDA, to the adult ADHD patient population, which represents approximately half of the total ADHD market in the U.S.
"We now have positive Phase III data proving the efficacy and safety of SPN-812 in a broad range of ADHD patient populations; children six-11 years old, adolescents 12-17 years old, and adults."
The study was a randomized, double-blind, placebo controlled, multicenter, parallel group clinical trial in adult patients diagnosed with ADHD. The study had a two-arm flexible dose design where treatment was administered orally once a day over six weeks, including the titration phase up to a total daily dose of 600mg SPN-812 or matched placebo.
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