CLOSE

Specials

I agree We use cookies on this website to enhance your user experience. By clicking any link on this page you are giving your consent for us to set cookies. More info

Skip to: Curated Story Group 1
lifesciencesreview
US
EUROPE
APAC
LATAM
  • Home
  • Contributors
  • News
  • Conferences
  • Newsletter
  • Whitepapers
  • Magazine
  • About
×
#

Life Science Review Weekly Brief

Be first to read the latest tech news, Industry Leader's Insights, and CIO interviews of medium and large enterprises exclusively from Life Science Review

Subscribe

loading

Thank you for Subscribing to Life Science Review Weekly Brief

  • Home
  • News

Recommended picks

Key Biotech Applications In Agriculture

Key Biotech Applications In Agriculture

Here's The List Of Top Biotech Stocks To Buy In 2022

Here's The List Of Top Biotech Stocks...

How Does Biotechnology Help Humans?

How Does Biotechnology Help Humans?

How Does Biotechnology Help Agriculture Sector Reap Benefits

How Does Biotechnology Help...

Biotechnology in Agriculture: Key Applications and Significance to Know

Biotechnology in Agriculture: Key...

DNA Sequencing Everything You Need to Know

DNA Sequencing Everything You Need to...

The Applications of Data Analytics in Biotechnology

The Applications of Data Analytics in...

BioCardia to Support Development of Potential Cell Therapy Products

BioCardia to Support Development of...

Key Biotech Applications In Agriculture

Key Biotech Applications In Agriculture

Here's The List Of Top Biotech Stocks To Buy In 2022

Here's The List Of Top Biotech Stocks...

How Does Biotechnology Help Humans?

How Does Biotechnology Help Humans?

How Does Biotechnology Help Agriculture Sector Reap Benefits

How Does Biotechnology Help...

Biotechnology in Agriculture: Key Applications and Significance to Know

Biotechnology in Agriculture: Key...

DNA Sequencing Everything You Need to Know

DNA Sequencing Everything You Need to...

The Applications of Data Analytics in Biotechnology

The Applications of Data Analytics in...

BioCardia to Support Development of Potential Cell Therapy Products

BioCardia to Support Development of...

Supernus Pharmaceuticals' New Drug Application Approved By FDA

Life Sciences Review Life Sciences Review | Tuesday, September 14, 2021
Tweet

FDA approves that Supernus Pharmaceuticals has received the supplemental new drug application (sNDA) for Qelbree.


FREMONT, CA: The U.S. Food and Drug Administration (FDA) has approved that Supernus Pharmaceuticals has received the supplemental new drug application (sNDA) for Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in adult patients. With a user fee goal date (PDUFA date) of April 29, 2022, the sNDA is now officially filed.


Supernus revealed favorable topline results from a Phase III study of Qelbree for the treatment of attention deficit hyperactivity disorder in adults in December 2020. (ADHD). The trial met the primary aim with robust statistical significance compared to placebo in improving ADHD symptoms from baseline to end of the study as judged by the ADHD Investigator Symptom Rating Scale at a daily dose of up to 600mg. 


In addition to satisfying the primary efficacy target, the Phase III study fulfilled the critical secondary efficacy endpoint of the Clinical Global Impression, Severity of Illness Scale change from baseline at week 6 with statistical significance. In April 2021, Qelbree got approved in the United States for the treatment of ADHD in children aged 6 to 17.


Jack Khattar, President and CEO of Supernus, said, “We look forward to making Qelbree available to adult patients, if approved by the FDA. Approximately 10 million adults in the U.S. have ADHD, and every adult who has ADHD had it as a child. Adults with ADHD often cope with difficulties at school, at work, and in their personal and family lives.”


Mr. Khattar continued, “We are currently focused on Qelbrees launch in the pediatric market and on providing physicians, parents and patients with a new ADHD treatment that is not a controlled substance with proven efficacy and a tolerable safety profile.”


Weekly Brief

loading
Top 10 Leading BioTech Solution Companies - 2021
> <
  • DNA Sequencing 2022

    Top Vendors

    Current Issue
  • BioTech Startups 2022

    Top Vendors

    Current Issue
  • DNA Sequencing 2022

    Top Vendors

    Current Issue
  • BioTech Startups 2022

    Top Vendors

    Current Issue

Read Also

Role of Predictive Genomics in Sustainable Healthcare

Role of Predictive Genomics in Sustainable Healthcare

A Conversational AI Approach to Regulatory Intelligence

A Conversational AI Approach to Regulatory Intelligence

A rise in DNA Sequencing Market is expected in coming years

A rise in DNA Sequencing Market is expected in coming years

Omniabio Inc. Announces Private Investor

Omniabio Inc. Announces Private Investor
Data analysis for next-generation sequencing worth USD1.2 billion by 2026 - Cloud-based platforms emerging as preferred solutions

Data analysis for next-generation sequencing worth USD1.2 billion by 2026 - Cloud-based platforms emerging as preferred solutions

Lithuania's Vision to Become a Biotech Hub in Europe

Lithuania's Vision to Become a Biotech Hub in Europe

Bridging the Diversity Gap in Genomics

Bridging the Diversity Gap in Genomics

How does Biotechnology Provide Solutions to Human Needs?

How does Biotechnology Provide Solutions to Human Needs?
Loading...

Copyright © 2022 Life Science Review . All rights reserved. |  Subscribe |  About Us follow on linkedin

This content is copyright protected

However, if you would like to share the information in this article, you may use the link below:

https://www.lifesciencesreview.com/news/supernus-pharmaceuticals--new-drug-application-approved-by-fda-nwid-555.html