Mydayis improves ADHD, functioning in adults
NEW ORLEANS — Data presented here indicated efficacy and safety of Mydayis, a once-daily mixed salts of a single-entity amphetamine product, for ADHD in adults.
“It was very important for us to pull all the studies together that we’ve studied in the adult population. The first one is the efficacy and safety poster comparing Mydayis [Shire] to placebo in three of our randomized controlled studies and one long-term study to allow everyone to assess the short-term efficacy and the long-term 52-week efficacy of Mydayis compared to placebo,” Manisha Madhoo, MD, vice president, Global Medical Affairs, Neuroscience, Shire, told Healio.com/Psychiatry. “The conclusions of these studies are that ... Mydayis is significantly clinically superior to placebo in the [ADHD Rating Scale] and [Clinical Global Impressions-Improvement]. In the global clinical function scale, Mydayis compared to placebo is superior.”
The FDA-approved Mydayis is available as a once-daily treatment of three different types of drug-releasing beads for individuals aged 13 years and older with ADHD.
To assess efficacy and safety of Mydayis for ADHD in adults, researchers conducted 4- to 7-week placebo-controlled studies among individuals aged 18 to 55 years. Analysis included a 12.5 mg to 75 mg optimized dose, and several fixed doses, including 12.5 mg, 25 mg, 37.5 mg, 50 mg and 75 mg. Researchers measured ADHD with the ADHD Rating Scale (ADHD-RS) total score change from baseline to end-of-study/early termination or week 4, and assessed treatment-emergent adverse events.
Least squares mean treatment differences indicated Mydayis was superior to placebo for total ADHD-RS score changes (P .001 for all).
According to data, treatment-emergent adverse events reported by at least 5% of participants in the Mydayis arm and at two times or more the placebo rate included decreased appetite, insomnia, dry mouth and anxiety.
Most insomnia events were mild or moderate, began early during treatment and resolved while receiving Mydayis without a dose change, according to researchers.
To determine efficacy and safety of Mydayis for global functioning in adults with ADHD, researchers assessed changes in Clinical Global Impressions-Improvement (CGI-I) scores. Researchers determined safety and tolerability by changes in vital signs from baseline to end-of-study/early termination.
At end-of-study/early termination, more participants who received Mydayis exhibited improvements in CGI-I scores for all dosages (P .001 for all).
From baseline to treatment end, mean changes in vital signs were as follows: pulse, 0.9 beats per minute to 7.1 beats per minute; systolic blood pressure, –0.3 mm Hg to 1.7 mm Hg; and diastolic blood pressure,–0.3 mm Hg to 2.8 mm Hg.
“It’s very important for clinicians to understand that as Mydayis is brought into the market, they have an option of a medication that has four dosings — 12.5, 25, 37.5 and 50 mg. It’s a tripled bead mixed amphetamine, so the first one is immediate release and the second two are the delayed releases,” Madhoo said. “We’ve studied Mydayis well enough to be able to receive approval from the FDA, which allows assessment of cardiovascular safety adverse events. The top five adverse events of these products were similar to that of long-acting amphetamines. So it’s really important [clinicians] understand how to use this medication in their clinical practice.” – by Amanda Oldt
Robertson B, et al. Effects of SHP465 mixed amphetamine salts extended-release on patient global functioning and vital signs in adults with attention-deficit/hyperactivity disorder. Presented at: U.S. Psychiatric and Mental Health Congress; Sept. 16-19, 2017; New Orleans.
Robertson B, et al. Efficacy and safety of SHP465 mixed amphetamine salts extended-release in adults with attention-deficit/hyperactivity disorder. Presented at: U.S. Psychiatric and Mental Health Congress; Sept. 16-19, 2017; New Orleans.
Disclosure: Madhoo is an employee of Shire.