Mixed phase 3 data for ADHD treatment presented at ASHP meeting

Mixed phase 3 data for ADHD treatment presented at ASHP meeting

CONFERENCE SPEAKER

Researchers shared mixed good news for the new treatment centanafadine for the treatment of attention-deficit/hyperactivity disorder at the American Society of Health-System Pharmacists 2023 Summer Meetings and Exhibition.1 Specifically, they found that centanafadine had a better safety profile and demonstrated more favorable tolerability, but was less effective than lisdexamfetamine dimesylate (Vyvanse) for adults with ADHD.

Recent Phase 3 clinical trials have demonstrated significant reductions in ADHD symptoms compared to placebo in adults treated with centanafadine, a serotonin-norepinephrine-dopamine triple reuptake inhibitor. Although centanafadine appeared to be well tolerated, the researchers conducted a match-adjusted indirect comparison comparing the safety and efficacy results between centanafadine versus the stimulants lisdexamfetamine, atomoxetine (Strattera), and the non-stimulant ER viloxazine (Qelbree).

Patient-level data were pooled from 2 centanafadine studies (NCT03605680 and NCT03605836) and 3 comparator studies: NCT00334880 for lisdexamfetamine, NCT00190736 for atomoxetine, and NCT04016779 for viloxazine ER. Propensity score weighting was used to match baseline characteristics, including age, gender, race, Adult ADHD Investigator Symptom Rating Scale (AISRS/ADHD-RS) score, Clinical Global Scale score Impression-Severity of Illness and for centanafadine and viloxazine ERbody mass index. Estimated risk differences, which represent the incremental risk of each adverse event with centanafadine versus placebo versus placebo, were also reported.

The baseline characteristics after matching were the same in all trials. Adverse outcomes (eg, dry mouth, insomnia, anxiety, nausea, lack of appetite, and fatigue) were evaluated. The risk difference between centanafadine and lisdexamfetamine was -23.43% for lack of appetite, -19.27% ​​for dry mouth, and -15.35% for insomnia; between centanafadine and atomoxetine, the risk difference was -18.64% for nausea and -17.44% for dry mouth, and between centanafadine and ER viloxazine, the risk difference was -11.07% for fatigue and -10 .67% for insomnia.

The investigators also evaluated the reduction from baseline in the AISRS/ADHD-RS score. Adults with ADHD treated with lisdexamfetamine experienced a 6.58-point greater reduction from baseline scores than those treated with centanafadine. There were no statistically significant changes in AISRS score from baseline between centanafadine and atomoxetine or viloxazine ER (2.02 and 0.90 points, respectively).

Centanafadine showed a better safety/tolerability profile than lisdexamfetamine, atomoxetine and viloxazine ER, as evidenced by a significantly lower incidence of several adverse side effects, the researchers noted. Efficacy was lower than lisdexamfetamine and no different than atomoxetine and viloxazine ER.

This study provides important insights into the relative efficacy and safety of common treatment options for adults with ADHD to help inform treatment decisions, they concluded.

The researchers also noted that future studies are needed to better understand how the trade-off between safety/tolerability and efficacy affects management in clinical practice and patient treatment preferences.

Reference

1. Schein J. Evaluation of centanafadine in adults with ADHD: a matched indirect comparison versus lisdexamfetamine dimesylate, atomoxetine, and viloxazine ER. Presented at: American Society of Health-System Pharmacists Summer Meetings and Exhibition; 10-14 June 2023; Baltimore, MD.

This conference reporter originally appeared with Drug topics, Psychiatric Times‘ sister publication.

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