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Dyanavel XR effective, safe for ADHD in children
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SAN ANTONIO — Poster data presented here indicated efficacy and safety of Dyanavel XR, an extended-release oral suspension amphetamine for attention-deficit/hyperactivity disorder in children aged 6 years and older.
To assess efficacy and safety of Dyanavel XR (amphetamine, Tris Pharma), Ann C. Childress, MD, of the Center for Psychiatry and Behavioral Medicine Inc., Las Vegas, and colleagues conducted a randomized, double-blind study among 108 children with ADHD. Study participants had a mean age of 9.4 years. Participants began treatment with 2.5 mg or 5 mg of extended-release amphetamine per day and were titrated in 2.5 mg to 10 mg per day increments until an optimal dose was achieved. Maximum dosage was 20 mg per day. Participants received amphetamine or placebo for 7 days. Efficacy was assessed at 1, 2, 4, 6, 8, 10, 12 and 13 hours’ post-dose.
Change in Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) combined score from baseline to 4 hours after dosing was statistically significant, compared with placebo (P < .0001).
Change in SKAMP combined scores from baseline to 1, 2, 6, 8, 10, 12 and 13 hours after dosing was also statistically significant (P < .0001) vs. placebo.
Onset of treatment effect occurred at 1 hour post-dose, which was the earliest time point assessed, with a mean treatment difference of –10.2 (P < .0001).
Duration of efficacy persisted until the final time point, 13 hours after dosing, with a mean treatment difference of –9.2 (P < .0001).
“Efficacy of extended-release oral suspension amphetamine was demonstrated vs. placebo for the treatment of children aged 6 to 12 years with ADHD,” the researchers wrote. “extended-release oral suspension amphetamine was well-tolerated in this study, with a safety profile similar to other extended-release amphetamines.” – by Amanda Oldt
Reference:
Childress AC, et al. The efficacy and safety of amphetamine extended-release oral suspension in children with ADHD. Presented at: U.S. Psychiatric and Mental Health Congress; Oct. 21-24, 2016; San Antonio.
Disclosure: Childress reports receiving research support, serving as a consultant, an advisory board member and/or speaker for Shire Pharmaceuticals, Pfizer, Noven, NextWave Pharmaceuticals, Lilly USA, Forest Research Institute, Otsuka, Sunovion, Ironeshare, Rhodes, Theravance, Neurovance, Neos, Arbor, Tris Pharma, Purdue, Lundbeck, Alcobra, and Pearson.