New research suggests that the medication dasotraline, a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), may be one step closer to FDA approval for the treatment of ADHD in children.
Encouraging new research suggests that the medication dasotraline, a dual-acting dopamine and norepinephrine reuptake inhibitor , may be one step closer to FDA approval for the treatment of ADHD in children. The study, published in thefound that 4 mg of dasotraline is an effective and tolerable treatment for attention deficit hyperactivity disorder in children aged 6 to 12 years.
The research was conducted by dasotraline manufacturer Sunovion Pharmaceuticals Inc., in conjunction with AVIDA Inc. and thein Las Vegas, in response to the U.S. Food and Drug Administration and its 2018 request for additional clinical data on dasotraline’s efficacy and tolerability for the treatment of ADHD.
The FDA said it could not approve dasotraline’s New Drug Application for ADHD treatment without additional research like thisThe randomized, double-blind study included 112 children with ADHD, ages 6 to 12 years, half of whom received a once-daily evening dose of dasotraline 4 mg or placebo for 14 days.
Participants treated daily with dasotraline had significantly greater least squares mean improvement from their baseline to Day 15 in the SKAMP-combined score, in the SKAMP-attention subscale score, and in the SKAMP-deportment subscale scores.
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