Sunovion's Dasotraline To Be Filed In US For ADHD Despite Uncertainties

Sunovion is pressing ahead with plans for an FDA filing for its ADHD drug dasotraline in adult and children patients despite ongoing uncertainty over the drug's efficacy in the older grouping.

ADHD

Armed with fresh - and positive – top-line Phase III results, Sunovion Pharmaceuticals Inc. has confirmed it will file its attention-deficit hyperactivity disorder (ADHD) drug dasotraline this year for use in both adults and pediatric populations despite lingering clouds over its potential in older patients.

Sunovion said it took the decision in light of positive top-line results evaluating dasotraline in children aged between six and 12 with

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Chinese Firms Build Obesity Clinical Pipeline But Face Wider Hurdles

 
• By 

Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.

Aldeyra Plans To File Reproxalap Again With New Dry Eye Symptom Data

 
• By 

The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.

Pipeline Watch: Thirteen Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Accelerated Approval May Be Out Of Reach For PTC’s Huntington’s Drug

 
• By 

PTC said its updated Phase II data for PTC 518 met the primary endpoint of Huntingtin’s protein reduction, but analysts said there isn’t clear correlation with clinical benefit.

More from R&D

Accelerated Approval May Be Out Of Reach For PTC’s Huntington’s Drug

 
• By 

PTC said its updated Phase II data for PTC 518 met the primary endpoint of Huntingtin’s protein reduction, but analysts said there isn’t clear correlation with clinical benefit.

In Brief: Genmab To Seek FDA Nod For Epkinly In Lymphoma

 

Genmab will submit an sBLA for Epkinly in R/R follicular lymphoma in H1 2025, backed by positive Phase III data.

Merck & Co. CMO Barr On Breaking Into Immunology And Ophthalmology

 

Chief medical officer Eliav Barr discussed Merck’s investment in new therapeutic areas and business development in an interview with Scrip.