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Supernus Announces U.S. FDA Acceptance for Review of the New Drug Application for SPN-812 for the Treatment of ADHD

Jan. 21, 2020: Supernus Pharmaceuticals reported that the U.S. FDA has discovered the New Drug Application (NDA) for SPN-812(serotonin norepinephrine modulating agent) for the treatment of kids and youths with consideration shortfall hyperactivity issue (ADHD) worthy for audit.

The FDA has appointed a Prescription Drug User Fee Act (PDUFA) target activity date of November 8, 2020. If FDA approve SPN-812, will be the first new therapy to treat ADHD.

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The NDA for SPN-812 depends on information from a broad improvement program comprising of four Phase III clinical preliminaries that concentrated the pediatric patient populace from the age of 6 to 17 years, two Phase II clinical preliminaries, a few Phase I preliminaries, a long haul open name augmentation study, preclinical testing, and medication fabricating information.

Every one of the four crucial clinical preliminaries indicated a decrease in ADHD-RS-5 all out score as ahead of schedule as Week 1 and proceeding until the finish of the clinical investigation, just as progress in both hyperactivity/impulsivity and negligence subscales.

The impact was factually critical for the examinations for 100mg, 200mg, and 400mg portions. SPN-812 had a satisfactory security profile with low frequency of antagonistic occasions and low suspension rates.

What’s more, during the final quarter of 2019, the Company started a Phase III program to examine SPN-812 in the grown-up ADHD persistent populace.


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