Andrew Cutler, MD, shares insights on the results of a Phase III trial that shows great promise in the treatment of ADHD.
According to the Centers for Disease Control, about 6.1 million children in the United States have been diagnosed with attention-deficit/hyperactivity disorder. While the number of available agents has grown over the years, many options have harsh side effect profiles or do not fully address the symptoms.
Results from a phase III randomized, placebo-controlled study of a new agent showed promise of a safe and effective new treatment option. The results appear in Clinical Therapeutics.
In this Psychiatric Times Mental Health Minute, Andrew Cutler, MD, shares highlights of the SPN-812 study. Cutler is a trial investigator and clinical professor of psychiatry, SUNY Upstate Medical University.
Cutler explains the agent, a multimodal serotonergic and noradrenergic modulating agent and non-stimulant medication, was successful in in improving symptoms of ADHD in children and met both primary and secondary outcome measures. In addition, he notes efficacy was seen as early as one week after initiating treatment, which is unlike many of the other treatments available. The agent also appeared to be well tolerated.
According to a press release, SPN-812 has PDUFA target action date of Nov. 8, 2020.