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▎The content team editor of WuXi AppTec recently, Supernus Pharmaceuticals announced that the US FDA has approved the company's Qelbree (viloxazine sustained-release capsules) to treat attention deficit hyperactivity disorder (ADHD) in pediatric patients aged 6-17.
The press release states that this is the first innovative non-stimulant therapy for ADHD in ten years.
ADHD, commonly known as hyperactivity, is a chronic brain disease characterized by inability to concentrate, hyperactivity, and impulsiveness.
ADHD symptoms may begin when children are 3-6 years old and can continue into adolescence and adulthood.
ADHD is the most common mental illness in childhood, affecting 8% to 9% of school-age children.
There is currently no cure for ADHD, and existing therapies are designed to help relieve symptoms.
Qelbree developed by Supernus is a norepinephrine reuptake inhibitor with specific serotonin regulation activity.
The safety of this drug has been extensively verified in Europe and has been used as an antidepressant drug for many years.
In clinical trials, patients were able to observe the effect of Qelbree within a week after taking Qelbree, while the initially approved non-stimulant therapy may require 6 weeks of treatment to be able to observe the effect.
Qelbree’s approval is supported by 4 phase 3 clinical trials involving more than 1,000 pediatric patients aged 6-17 years.
In December last year, Supernus announced that this innovative therapy has also obtained positive results in a phase 3 clinical trial for the treatment of adult ADHD patients.
The company plans to submit a supplementary new drug application in the second half of this year to expand the use of Qelbree in adult patients."Based on the efficacy shown in clinical development projects, we believe that Qelbree provides a unique alternative treatment for ADHD.
" Supernus President and CEO Jack A.
Khattar said, "Qelbree provides doctors and ADHD patients with a A treatment option with proven efficacy and acceptable safety, and does not contain pharmaceutical ingredients that require special regulatory procedures.
"Reference: [1] Supernus Announces FDA Approval of Qelbree™ (SPN-812) for the Treatment of ADHD .
Retrieved April 2, 2021, from for-the-Treatment-of-ADHD.
html Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
The press release states that this is the first innovative non-stimulant therapy for ADHD in ten years.
ADHD, commonly known as hyperactivity, is a chronic brain disease characterized by inability to concentrate, hyperactivity, and impulsiveness.
ADHD symptoms may begin when children are 3-6 years old and can continue into adolescence and adulthood.
ADHD is the most common mental illness in childhood, affecting 8% to 9% of school-age children.
There is currently no cure for ADHD, and existing therapies are designed to help relieve symptoms.
Qelbree developed by Supernus is a norepinephrine reuptake inhibitor with specific serotonin regulation activity.
The safety of this drug has been extensively verified in Europe and has been used as an antidepressant drug for many years.
In clinical trials, patients were able to observe the effect of Qelbree within a week after taking Qelbree, while the initially approved non-stimulant therapy may require 6 weeks of treatment to be able to observe the effect.
Qelbree’s approval is supported by 4 phase 3 clinical trials involving more than 1,000 pediatric patients aged 6-17 years.
In December last year, Supernus announced that this innovative therapy has also obtained positive results in a phase 3 clinical trial for the treatment of adult ADHD patients.
The company plans to submit a supplementary new drug application in the second half of this year to expand the use of Qelbree in adult patients."Based on the efficacy shown in clinical development projects, we believe that Qelbree provides a unique alternative treatment for ADHD.
" Supernus President and CEO Jack A.
Khattar said, "Qelbree provides doctors and ADHD patients with a A treatment option with proven efficacy and acceptable safety, and does not contain pharmaceutical ingredients that require special regulatory procedures.
"Reference: [1] Supernus Announces FDA Approval of Qelbree™ (SPN-812) for the Treatment of ADHD .
Retrieved April 2, 2021, from for-the-Treatment-of-ADHD.
html Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
