SPN-812 Gains Another Positive Study for the Treatment of Adolescents with ADHD

SPN-812, a new drug for the treatment of attention deficit hyperactivity disorder (ADHD), met its primary endpoint with “” in its third positive phase III study. SPN-812 comes from Supernus Pharmaceuticals, a pharmaceutical company focused on the development and commercializing of products for the treatment of central nervous system diseases.

Using daily doses of 200mg and 400mg the trial found that there was improvement in the symptoms of ADHD from baseline to the end of study. The study, known as P302, was a randomized, double-blind, placebo controlled, multicenter, parallel group clinical trial in patients aged 12-17 diagnosed with ADHD. This was measured by the ADHD Rating Scale-5 and both active doses were well tolerated.

SPN-812 is a novel non-stimulant that Supernus is developing for the treatment of ADHD. It is a norepinephrine reuptake inhibitor, with selective serotonin modulation activity, with the active ingredient of viloxazine hydrochloride. Viloxazine Hydrochloride has been tested in Europe with a good safety record and was previously marketed there as an antidepressant. Supernus believes that thanks to SPN-812’s main active ingredient and pharmacological and pharmacokinetic profile that it will stand out compared to other ADHD non-stimulant treatments.

In the study, patients who received both doses had a -16.0-point change (p=0.0232) and a -16.5-point change (p=0.0091) from baseline, respectively, in the primary endpoint, compared to -11.4 for placebo at week 6. In terms of effect size, patients who received 200mg had an effect size of 0.47 and a 400mg dose had an effect size of 0.50. This was in the range of 0.46 and 0.63 shown in the in the first two Phase III studies. Furthermore, statistical significance was reached in the third week of the trial and maintained for the remainder of the trial.

The trial also found SPN-812 to have favorable safety and tolerability profiles with a very low incidence rate of adverse events for both doses. The discontinuation rates due to adverse effects were in between 1.9% to 4.1%. SPN-812, both 200mg and 400mg doses, hit the Clinical Global Impression-Improvement secondary endpoint with p-values of 0.0042 and 0.0003 respectively.

“This data further reinforces the effectiveness of SPN-812 in patients with ADHD, showing a clinically meaningful reduction in the symptoms of ADHD, with a favorable safety and tolerability profile,” stated Jack Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “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.”