Phase 3 study reveals efficacy of dasotraline in children 6 to 12 years old.
Sunovion Pharmaceuticals Inc. today announced results of a phase 3 pivotal study on novel drug candidate dasotraline, a dopamine and norepinephrine reuptake inhibitor being tested in children 6 to 12 years old with attention deficit hyperactivity disorder (ADHD).
In a laboratory classroom setting, dasotraline showed persistent, statistically significant improvement in ADHD symptoms in 6- to 12-year-old children 12 to 24 hours after dosage compared to a placebo, a Sunovion press release said.
“ADHD symptoms can have a significant impact on all aspects of a child’s life, inside and outside of the classroom,” said Ann C. Childress, MD. “Treatment options that provide sustained improvement in ADHD symptoms throughout the day can have a profound effect on the lives of children living with ADHD and their parents or caregivers.”
Dasotraline has an extended half-life of 47-77 hours that supports the potential for sustained improvement in ADHD symptoms and a continuous therapeutic effect. During the phase 3 trials, Sunovion’s novel drug demonstrated efficacy for up to 24 hours, maintaining significant separation from placebo 12 to 24 hours post-dose.
The primary endpoint of phase 3 dasotraline testing was the change from baseline of ADHD symptoms at day 15 compared to a placebo-treated group. Secondary efficacy endpoints included subscales that measured attention and deportment, as well as performance based on the number of attempted and completed math problems.
According to the release, dasotraline was generally well tolerated in patients and had an adverse event profile consistent with completed studies in children and adults. The most common treatment-emergent adverse events included insomnia, decreased appetite, affect lability, headache and irritability.
“These results add to our body of knowledge about dasotraline and reinforce its potential as a treatment option poised to address significant gaps in available treatment,” said Antony Loebel, MD, Sunovion Executive Vice President and Chief Medical Officer.
The global pharmaceutical company said that while dasotraline has not been approved by the US Food and Drug Administration (FDA), it will submit a New Drug Application (NDA) to the FDA in the fiscal year 2017 for the treatment of ADHD, and further investigate dasotraline as a potential treatment for binge eating disorder (BED) in adults as well.
In January Sunovion announced that a phase 2 study evaluating dasotraline in adults aged 18 to 55 years old with moderate to severe BED met the primary efficacy endpoint as well as all key secondary efficacy endpoints.
Prior to releasing positive results on dasotraline in children, Sunovion publicized the results of a phase 3 study in January that measured the drug’s efficacy in adults aged 18 to 55 years old with ADHD. It did not meet its primary endpoint.
Sunovion’s phase 3 trial on children between the ages of 6 and 12 with ADHD was a two-week, randomized, double-blind, multi-center, placebo-controlled, fixed-dose study comparing dasotraline with placebo in 112 children.