Shire announced that the Food and Drug Administration (FDA) has approved once-daily Mydayis (mixed salts of single-entity amphetamine product) extended-release capsules for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged ≥13 years.
The FDA approval was based on data from 16 trials evaluating Mydayis in >1,600 adolescents and adults with ADHD. Study data showed treatment with Mydayis significantly improved ADHD symptoms, as assessed by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in both adolescents and adults. Improvements on the PERMP was deemed statistically significant, which started at 2 or 4 hours post-dose and sustained up to 16 hours post-dose.
Other Phase 3 efficacy studies demonstrated that Mydayis taken in the morning was superior to placebo as measured by change from baseline in the ADHD-RS-IV total score for adolescents and adults. In several Phase 2 studies, patients treated with Mydayis had improved attention vs. placebo, as measured by the total PERMP score. Statistically significant improvements were seen at 2 or 4 hours post-dose and were sustained up to 16 hours post-dose.
The most frequent adverse reactions with Mydayis in adults were insomnia, decreased appetite, decreased weight, dry mouth, increased pulse, and anxiety. In pediatric patients, insomnia, decreased appetite, decreased weight, irritability, and nausea were most commonly reported.
Mydayis, a Schedule II controlled substance, is a CNS stimulant. Amphetamines block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
Mydayis will be available as 12.5mg, 25mg, 37.5mg, and 50mg strength extended-release capsules in 100-count bottles. It is anticipated to launch in the third quarter of 2017.
For more information call (800) 828-2088 or visit Mydayis.com.