ADHD reaches major endpoint in two key Phase 3 clinical trials

ADHD, commonly known as ADHD, is a chronic brain disease that manifests itself as unable to concentrate, hyperactivity and impulsivenesstoday, Supernus Pharmaceuticals(http://announced that itsdrug(http://SPN-812 for the treatment of children's attention deficit hyperactivity disorder (ADHD) reached its main point in two key Phase 3 clinicaltrial(http://Supernus Pharmaceuticals plans to submit aapplication fornew drug(http:// to theFDA(http://in the second half of next yearSPN-812 Supernus is a norepinephrine reuptake inhibitor with specific 5-serotonin regulatory activity 　　The safety of SPN-812 has been widely proven in Europe and has been used for many years as an antidepressant drug Supernus aims to develop it as an innovative non-stimulant ADHD therapy studies
in two randomized double-blind, placebo-controlled, multicenter parallel Phase 3 clinical trials called P301 and P303, children with ADHD ages 6-11 were treated with different doses of SPN-812 A total of 477 patients received SPN-812 or placebo treatment with a dose of 100 mg or 200 mg in the P301 trial A total of 313 patients were treated with SPN-812 or placebo at doses of 200 mg and 400 mg in the P303 trial the main endpoint of the two trials was a change in the ADHD RS-5 score compared to the baseline at the end of the trial results showed that in the P301 trial, the 100 mg and 200 mg dose of SPN-812 therapy reached the main endpoint Patients treated with SPN-812 of 100 mg and 200 mg scored 16.6 (p-0.0004) and 17.7 (p0.0001) after 6 weeks, while the placebo group scored 10.9 notably, the symptoms improved significantly in the first week after treatment At the same time, two doses of SPN-812 therapy also reached all the secondary endpoints of the trial In the P303 trial, sPN-812 therapy in doses of 200 mg and 400 mg also reached its main endpoint After 8 weeks of treatment, the 200 mg group scored 17.6 (p.0.0038), the 400 mg group scored 17.5 (P-0.0063) and the placebo group decreased by 11.7