An assessment of injection site reaction and injection site pain of 1-month and 3-month long-acting injectable formulations of paliperidone palmitate

Purpose To evaluate injection site reactions and pain following paliperidone palmitate 1-month (PP1M) and 3-month (PP3M) administration using safety data of double-blind (DB), noninferiority study. MethodsFindingsPatients (n=1,429) with schizophrenia, treated with PP1M (50-150mg-eq, 17-week open-label [OL] phase) were randomized to PP1M or PP3M in 48-week DB phase. PP1M and PP3M injections were well tolerated. Incidence of induration, redness, and swelling were low in both phases (OL: 9-12%; DB: 7-13%), and were mostly mild in both groups. Mean (SD) visual analog scale scores decreased from OL-baseline (22.0 [21.6]) to DB-baseline (19.5 [20.6] vs. 18.4 [20.4]) and DB-endpoint (15.6 [17.9] vs. 15.5 [18.3]). Practice ImplicationsInjection site reactions and pain were low and similar between both treatments, regardless of administration site and dose.