Amphetamine Extended-Release tablet safe against attention deficit/hyperactivity disorder

Adults with attention deficit/hyperactivity disorder (ADHD) can benefit from and feel safe using amphetamine extended-release pills, says an article published in The Journal of Clinical Psychiatry.

The incidence of ADHD, which often first appears in infancy, is estimated to be 4.4% among people between the ages of 18 and 44. The 3.2:1 blend of d- and l-amphetamine found in the amphetamine base product known as the Amphetamine Extended-Release Tablet (AMPH ER TAB) was created utilizing the patented LiquiXR drug delivery system. According to earlier research, a single dose of 30 mg of mixed amphetamine salts is bioequivalent to 18.8 mg of the amphetamine base product amphetamine extended-release oral suspension (AMPH EROS). Andrew J. Cutler and colleagues carried out this study in order to assess the effectiveness and safety of amphetamine extended-release tablets in people with attention-deficit/hyperactivity disorder.

Subjects were randomly assigned to either oral double-blind AMPH ER TAB 5-mg beginning dosage or matched placebo once daily in the morning over a 5-week forced-dose titration phase. Weekly evaluations of safety and effectiveness were done. Following visit three, individuals took 20 mg for 14 ±  3 days before visit five. Serial Permanent Product Measure of Performance (PERMP) tests were administered pre-dose and at 0.5, 1, 2, 4, 8, 10, 12, and 14 hours after delivery as part of the effectiveness evaluations at visit number five. The mean PERMP Total score (PERMP-T) throughout post-dose time points over the visit of 5 serial PERMPs served as the main effectiveness outcome. Adverse events (AEs) recorded at each visit, the Columbia Suicide Severity Rating Scale (C-SSRS), weight, vital signs, physical exam, and evaluation of hunger, sleep, mood, and psychotic AEs were all used to evaluate patient safety. The research was done from February through October of 2019.

The key findings of this study were as follow:

1. Out of 130 randomly assigned individuals, 127 were in the ITT population and 91 finished the research.

2. At visit 5, the AMPH ER TAB group had a mean PERMP-T that was statistically greater than the placebo group across all post-dose time periods.

3. All time points showed numerical changes in favor of AMPH ER TAB, with statistically significant benefits in the AMPH ER TAB group at 30 minutes, 1, 2, 4, 8, and 13 hours post-dose, but not at 10, 12, or 14 hours.

4. Reduced appetite, sleeplessness, and dry mouth were typical adverse effects.

5. There were no significant adverse events (AEs), as defined by the US Food and Drug Administration, reported, and the majority of treatment-emergent AEs were mild to moderate in intensity.

In conclusion, Amphetamine has a track record of success as an effective medication for the amelioration of ADHD symptoms. Amphetamine's effectiveness and safety, along with the quick absorption and extended-release profile offered by the LiquiXR drug delivery system established in this trial, provide patients with ADHD a novel solid-dose therapy alternative that may be chewed or ingested whole.

Reference:

Cutler, A. J., Childress, A. C., Pardo, A., Duhoux, S., Gomeni, R., Rafla, E., King, T. R., & Kando, J. C. (2022). Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of Amphetamine Extended-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder. In The Journal of Clinical Psychiatry (Vol. 83, Issue 5). https://doi.org/10.4088/jcp.22m14438