Corium's Azstarys (serdexmethylphenidate and dexmethylphenidate) Receives the US FDA's Approval for ADHD in Patients Aged 6 Years and Older
Shots:
- The approval is based on a P-III study that involves assessing Azstarys (qd) vs PBO in 150 children aged 6-12yrs. with ADHD
- The study showed improvement in 1EPs i.e. ADHD symptoms- reduction in SKAMP-C score (-5.4points)
- Azstarys is the first and only product containing a d-MPH oral prodrug for the treatment of ADHD and will be available as 3 dosage strength- 26.1/5.2 mg- 39.2/7.8 mg- and 52.3/10.4 mg with the anticipated launch in summer 2021
Ref: PRNewswire | Image: Twitter
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