Improved Performance Scores Reported With Amphetamine Extended-Release Tablets for ADHD

The efficacy and safety of the amphetamine extended-release tablet (AMPH ER TAB; Dynavel XR Tablet, Tris Pharma, Inc.) for symptoms of attention-deficit/hyperactivity disorder (ADHD) in adults were reported in a phase 3 trial, the results of which were presented at Psych Congress 2021, held both online and in person in San Antonio, Texas, between October 29 and November 1.

Researchers conducted Permanent Product Measure of Performance (PERMP) assessments at screening or baseline in adults aged 18 to 60 years with ADHD. At baseline, the participants had Adult ADHD Investigator Symptom Rating Scale (AISRS) scores of at least 26 and Clinical Global Impression – Severity (CGI-S) scores of at least 4. Exclusion criteria included pregnancy/lactation, a known history of chronic medical illnesses or significant renal or hepatic disease, and the use of monoamine oxidase inhibitors or tricyclic antidepressants in the past month.

For a study period of 5 weeks, patients (aged 32±11 years) took 1 dose of the test product (n=65) or matching placebo (n=62) before 10 AM each morning. The dose of AMPH ER TAB the experimental group received increased by 5 mg each week. The researchers assessed safety and efficacy of the doses weekly by monitoring adverse events, obtaining Columbia-Suicide Severity Rating Scale scores, and assessing weight and vital signs. Following the third visit, participants received a dose of 20 mg for 14±3 days, before visit 5. At visit 4, patients performed the PERMP predose and at 0.5, 1, 2, and 4 hours postdose. The researchers compared PERMP scores at visit 5 predose and at 0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours postdose with the PERMP obtained at baseline.

Patients who took the AMPH ER TAB were found to have significantly higher mean postdose PERMP total scores at the 0.5-, 1-, 2-, 4-, 8-, and 13-hour postdose time points at visit 5 compared with patients who took placebo (overall 302.8 vs 279.6; P =.0043). Mean predose PERMP scores at visit 5 were comparable between the 2 groups (259.5 and 260.6 respectively).

A total of 91 individuals completed the study. In the AMPH ER TAB group, 86% experienced treatment-related treatment emergent adverse events (TEAEs), 90% experienced AEs, and 87% experienced TEAEs. In the placebo group, 48% experienced treatment-related TEAEs, 60% experienced AEs, and 54% experienced TEAEs. No severe TEAEs or deaths occurred during the study. Three individuals discontinued participation after experiencing AEs. Reported AEs occurring in more than 2% of participants included insomnia, irritability, initial insomnia, and decreased appetite.

“Based on the results of this clinical study the safety profile of the AMPH ER TAB appears similar to other amphetamine extended-release products,” the researchers said. “The tablet can be chewed or swallowed whole, and may offer a new ADHD treatment option for adults patients based on the tablets’ palatability and pharmacokinetic profiles.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical and/or device companies. This research was supported by Tris Pharma, Inc. Please see the original reference for a full list of disclosures.

Reference

Cutler AJ, Childress AC, Everitt A, et al. Randomized, double-blind, placebo-controlled, fixed-dose, parallel group study to evaluate the efficacy and safety of the amphetamine extended-release tablet (AMPH ER TAB) in adults with ADHD. Poster presented at: Psych Congress 2021, October 29-November 1, 2021; San Antonio, Texas. Poster 40.