A potential treatment for attention-deficit/hyperactivity disorder goes back to the drawing board.
Supernus Pharmaceuticals, Inc recently announced regulatory updates on their drugs, SPN-812 for the treatment of attention-deficit/hyperactivity disorder. The United States Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) stating SPN-812 is not ready for approval in its present form.
“On SPN-812, we look forward to collaborating with the FDA to clarify and resolve the facility matter and put SPN-812 back on track to help the millions of children and adolescents in the US with ADHD,” Jack Khattar, President and CEO of Supernus, said to the press.1
SPN-812, or viloxazine hydrochloride, is a novel non-stimulant intended for the treatment of ADHD in pediatric patients aged 6 to 17. The application for SPN-812 included data from 4 Phase III clinical trials, in which the serotonin norepinephrine modulating agent of SPN-812 caused improvements in both the hyperactivity/impulsivity and inattention subscales of the ADHD Rating Scale V.2
Supernus plans to discuss and clarify the CRL for SPN-812 with the FDA. The main issue cited in the letter is Supernus’ in-house analytical testing laboratory, which has recently move to a new location. The application does not solely rely on this facility for product release, which is hoped to be brought up in discussions, along with the resubmission of the NDA for SPN-812.
Supernus plans to provide further updates on the expected launch timing for SPN-812 after their discussion with the FDA.
1. Supernus Pharmaceuticals. Supernus Provides Regulatory Updates for SPN-812 and SPN-830. News release. GlobeNewswire. November 9, 2020. https://www.globenewswire.com/news-release/2020/11/09/2123296/0/en/Supernus-Provides-Regulatory-Updates-for-SPN-812-and-SPN-830.html
2. Bratulic A. FDA rebuffs Supernus filings for ADHD, Parkinson’s disease treatments. FirstWord Pharma. November 10, 2020. https://beta.firstwordpharma.com/story/5148683