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April 06, 2021 // --Supernus Pharma is a professional biopharmaceutical company focusing on the development and commercialization of drugs for the treatment of central nervous system (CNS) diseases.
Recently, the company announced that the U.
S.
Food and Drug Administration (FDA) has approved Qelbree (viloxazine, viloxazine, sustained-release capsules), which is a serotonin-norepinephrine modulator (SNMA).
It is used to treat pediatric patients with attention deficit hyperactivity disorder (ADHD) aged 6-17 years.
Recently, the company announced that the U.
S.
Food and Drug Administration (FDA) has approved Qelbree (viloxazine, viloxazine, sustained-release capsules), which is a serotonin-norepinephrine modulator (SNMA).
It is used to treat pediatric patients with attention deficit hyperactivity disorder (ADHD) aged 6-17 years.
It is worth mentioning that Qelbree represents the first non-stimulant therapy in ADHD treatment in ten years.
Supernus plans to launch Qelbree in the US market in the second quarter of 2021.
In terms of medication, Qelbree is taken orally once a day, swallowed as a whole capsule, or sprinkled on applesauce.
Supernus plans to launch Qelbree in the US market in the second quarter of 2021.
In terms of medication, Qelbree is taken orally once a day, swallowed as a whole capsule, or sprinkled on applesauce.
ADHD (Image source: askdrmakkar.
com)
com)
Qelbree's approval is backed by an extensive development project data.
The project includes 4 phase 3 clinical trials, enrolling more than 1,000 children with ADHD aged 6-17 years.
In December 2020, the company announced that the Phase 3 trial in adult patients with ADHD has achieved positive results, and plans to submit a supplementary new drug application to the FDA in the second half of 2021 to use Qelbree for the treatment of adult patients with ADHD.
The project includes 4 phase 3 clinical trials, enrolling more than 1,000 children with ADHD aged 6-17 years.
In December 2020, the company announced that the Phase 3 trial in adult patients with ADHD has achieved positive results, and plans to submit a supplementary new drug application to the FDA in the second half of 2021 to use Qelbree for the treatment of adult patients with ADHD.
It is worth noting that Qelbree may increase suicidal thoughts and behavior in some children with ADHD, especially during the first few months of treatment or when the dose is changed.
Therefore, you need to pay close attention to any new or sudden changes in emotions, behaviors, thoughts, and feelings.
In addition, patients who are taking certain antidepressants, especially monoamine oxidase inhibitors (MAOI), or certain asthma medications, should not take Qelbree.
Therefore, you need to pay close attention to any new or sudden changes in emotions, behaviors, thoughts, and feelings.
In addition, patients who are taking certain antidepressants, especially monoamine oxidase inhibitors (MAOI), or certain asthma medications, should not take Qelbree.
Jack a.
Khattar, President and CEO of Supernus, said: "Based on the efficacy shown in the clinical program, we believe that Qelbree will provide a unique new option for the treatment of ADHD.
Qelbree will provide an uncontrolled option for prescribing physicians and ADHD patients.
A treatment method that has been proven effective, safe and tolerable.
We thank the patients, their families and their caregivers who participated in and supported our research.
"
Khattar, President and CEO of Supernus, said: "Based on the efficacy shown in the clinical program, we believe that Qelbree will provide a unique new option for the treatment of ADHD.
Qelbree will provide an uncontrolled option for prescribing physicians and ADHD patients.
A treatment method that has been proven effective, safe and tolerable.
We thank the patients, their families and their caregivers who participated in and supported our research.
"
Andrew J.
Cutler, MD, associate clinical professor of psychiatry at North State Medical University, State University of New York and chief medical officer of the Institute of Neuroscience Education, said: "ADHD is one of the most common mental health problems in the United States.
For children and adolescents, it is correct.
The treatment is key because they grow and develop in school and social relationships.
This approval provides a novel non-stimulant that can be sprinkled on jam once a day.
For children and adolescents with ADHD, it will be a good choice.
"()
Cutler, MD, associate clinical professor of psychiatry at North State Medical University, State University of New York and chief medical officer of the Institute of Neuroscience Education, said: "ADHD is one of the most common mental health problems in the United States.
For children and adolescents, it is correct.
The treatment is key because they grow and develop in school and social relationships.
This approval provides a novel non-stimulant that can be sprinkled on jam once a day.
For children and adolescents with ADHD, it will be a good choice.
"()
Original source: Supernus Announces FDA Approval of Qelbree (SPN-812) for the Treatment of ADHD
April 06, 2021 // --Supernus Pharma is a professional biopharmaceutical company focusing on the development and commercialization of drugs for the treatment of central nervous system (CNS) diseases.
Recently, the company announced that the U.
S.
Food and Drug Administration (FDA) has approved Qelbree (viloxazine, viloxazine, sustained-release capsules), which is a serotonin-norepinephrine modulator (SNMA).
It is used to treat pediatric patients with attention deficit hyperactivity disorder (ADHD) aged 6-17 years.
Recently, the company announced that the U.
S.
Food and Drug Administration (FDA) has approved Qelbree (viloxazine, viloxazine, sustained-release capsules), which is a serotonin-norepinephrine modulator (SNMA).
It is used to treat pediatric patients with attention deficit hyperactivity disorder (ADHD) aged 6-17 years.
It is worth mentioning that Qelbree represents the first non-stimulant therapy in ADHD treatment in ten years.
Supernus plans to launch Qelbree in the US market in the second quarter of 2021.
In terms of medication, Qelbree is taken orally once a day, swallowed as a whole capsule, or sprinkled on applesauce.
Supernus plans to launch Qelbree in the US market in the second quarter of 2021.
In terms of medication, Qelbree is taken orally once a day, swallowed as a whole capsule, or sprinkled on applesauce.
ADHD (Image source: askdrmakkar.
com)
com)
Qelbree's approval is backed by an extensive development project data.
The project includes 4 phase 3 clinical trials, enrolling more than 1,000 children with ADHD aged 6-17 years.
In December 2020, the company announced that the Phase 3 trial in adult patients with ADHD has achieved positive results, and plans to submit a supplementary new drug application to the FDA in the second half of 2021 to use Qelbree for the treatment of adult patients with ADHD.
The project includes 4 phase 3 clinical trials, enrolling more than 1,000 children with ADHD aged 6-17 years.
In December 2020, the company announced that the Phase 3 trial in adult patients with ADHD has achieved positive results, and plans to submit a supplementary new drug application to the FDA in the second half of 2021 to use Qelbree for the treatment of adult patients with ADHD.
It is worth noting that Qelbree may increase suicidal thoughts and behavior in some children with ADHD, especially during the first few months of treatment or when the dose is changed.
Therefore, you need to pay close attention to any new or sudden changes in emotions, behaviors, thoughts, and feelings.
In addition, patients who are taking certain antidepressants, especially monoamine oxidase inhibitors (MAOI), or certain asthma medications, should not take Qelbree.
Therefore, you need to pay close attention to any new or sudden changes in emotions, behaviors, thoughts, and feelings.
In addition, patients who are taking certain antidepressants, especially monoamine oxidase inhibitors (MAOI), or certain asthma medications, should not take Qelbree.
Jack a.
Khattar, President and CEO of Supernus, said: "Based on the efficacy shown in the clinical program, we believe that Qelbree will provide a unique new option for the treatment of ADHD.
Qelbree will provide an uncontrolled option for prescribing physicians and ADHD patients.
A treatment method that has been proven effective, safe and tolerable.
We thank the patients, their families and their caregivers who participated in and supported our research.
"
Khattar, President and CEO of Supernus, said: "Based on the efficacy shown in the clinical program, we believe that Qelbree will provide a unique new option for the treatment of ADHD.
Qelbree will provide an uncontrolled option for prescribing physicians and ADHD patients.
A treatment method that has been proven effective, safe and tolerable.
We thank the patients, their families and their caregivers who participated in and supported our research.
"
Andrew J.
Cutler, MD, associate clinical professor of psychiatry at North State Medical University, State University of New York and chief medical officer of the Institute of Neuroscience Education, said: "ADHD is one of the most common mental health problems in the United States.
For children and adolescents, it is correct.
The treatment is key because they grow and develop in school and social relationships.
This approval provides a novel non-stimulant that can be sprinkled on jam once a day.
For children and adolescents with ADHD, it will be a good choice.
"()
Cutler, MD, associate clinical professor of psychiatry at North State Medical University, State University of New York and chief medical officer of the Institute of Neuroscience Education, said: "ADHD is one of the most common mental health problems in the United States.
For children and adolescents, it is correct.
The treatment is key because they grow and develop in school and social relationships.
This approval provides a novel non-stimulant that can be sprinkled on jam once a day.
For children and adolescents with ADHD, it will be a good choice.
"()
Original source: Supernus Announces FDA Approval of Qelbree (SPN-812) for the Treatment of ADHD
