The following article is a part of conference coverage from Psych Congress 2020 Virtual Experience, held virtually from September 10 to 13, 2020. The team at Psychiatry Advisor will be reporting on the latest news and research conducted by leading experts in psychiatry. Check back for more from the Psych Congress 2020.
SHP465 mixed amphetamine salts (MAS) effectively reduced symptoms of attention-deficit/hyperactivity disorder (ADHD) in adults, independent of ADHD treatment history, according to study data presented at Psych Congress 2020, held virtually from September 10 to 13, 2020.
This post hoc analysis pooled data from 2 placebo-controlled studies of SHP465 MAS extended-release for the treatment of adult ADHD. The first study was a 7-week dose-optimization study (SHP465 MAS 12.5-75 mg vs placebo); the second study was a 6-week fixed-dose study (SHP465 MAS 25, 50, or 75 mg vs placebo). In both studies, the primary efficacy outcome was change in ADHD-Rating Scale IV total score (ADHD-RS-IV-TS) from baseline to final study visit. The least squares mean differences between SHP465 MAS and placebo for change in ADHD-RS-IV-TS were determined for 2 groups of patients: patients who were treatment-naïve and patients with prior stimulant exposure (amphetamine or methylphenidate).
The least squares mean (95% confidence interval) treatment differences between SHP465 MAS and placebo were -9.74 (-11.77 to -7.70) and -11.80 (-16.10 to -7.50) for treatment-naïve patients and patients with prior stimulant exposure, respectively (both P <.0001). The magnitude of ADHD-RS-IV-TS improvement with SHP465 MAS was comparable between treatment-naïve and treatment-exposed groups. Adverse event frequency was greater in patients receiving SHP465 MAS vs placebo, regardless of prior treatment history. Among treatment-naïve patients, 85.8% of those receiving SHP465 MAS experienced treatment-emergent adverse events (AE), compared to 63.9% of those receiving placebo. Similarly, among those with prior treatment exposure, 76.9% and 56.8% reported treatment-emergent AE with SHP465 MAS and placebo, respectively.
These data suggest that SHP465 MAS effectively reduces ADHD symptoms in adults with and without prior stimulant exposure. As study limitations, investigators noted that the study cohort was primarily white (>80%), and most patients had the combined ADHD subtype. Additional research is needed to further assess the efficacy of this drug for the wider adult ADHD population.
Disclosure: This study was sponsored by Shire Development LLC, a member of the Takeda group of companies. Please see the original reference for a full list of authors’ disclosures.
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Arnold V, Lloyd E, Foraida S. Post hoc analyses of treatment history on SHP465 mixed amphetamine salts extended-release responses in adult attention-deficit/hyperactivity disorder. Presented at: Psych Congress 2020 Virtual Experience; September 10-13, 2020. Abstract 188.