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FDA accepts Supernus Pharma’s NDA review for SPN-812 in ADHD treatment
- SPN-812 will be important for the treatment of 6.1 million children, adolescents across U.S.
- The U.S. FDA has assigned a PDUFA target action date of November 8, 2020
Supernus Pharmaceuticals, Inc., a leading pharmaceutical firm involved in the development and commercialization of products to treat central nervous system (CNS) diseases, recently confirmed that the U.S. FDA has given a nod for the review of New Drug Application (NDA) for SPN-812 to treat both children and adolescents suffering from attention deficit hyperactivity disorder (ADHD).
Apparently, a Prescription Drug User Fee Act (PDUFA) has been assigned by the FDA with the action date of November 8, 2020.
Jack A. Khattar, the CEO and President of Supernus, commented that if the FDA approves SPN-812, it will be the first new therapy made for the treatment of ADHD in a decade. This therapy is important for about 6.1 million children as well as adolescents across the U.S. who have been diagnosed with this condition and are in dire need of treatment. This treatment is essentially a non-controlled substance that works in a different way compared to other available treatments.
For the record, NDA for SPN-812 has been based on the data from a large development program that consists of four Phase III clinical trials. These clinical trials have studied pediatric patient population starting from the age of 6 to 17 years, various Phase I trials, two of Phase II clinical trials, drug manufacturing data and preclinical testing, a long-term open-label extension study.
Every pivotal clinical trial exhibited a considerable reduction in ADHAD-RS-5, the total score by the very first week and has continued up until the clinical study ended. It has also shown an improvement in both impulsivity/hyperactivity as well as inattention subscales.
SPN-812 proved to have an acceptable safety profile that depicted a low incidence of harmful events and even lower discontinuation rates. Additionally, the company had started a Phase III program during 2019’s fourth quarter, in order to study SPN-812 found in the adult patient population.
Source Credit- http://ir.supernus.com/node/11466/pdf