title: Deltoid injections of risperidone long-acting injectable in patients with schizophrenia.
abstract: BACKGROUND
  Risperidone long-acting injectable was previously approved for treatment of schizophrenia as biweekly injections in the gluteal muscle only. We present data on local injection-site tolerability and safety of risperidone long-acting injectable and comparability of systemic exposure of deltoid versus gluteal injections.
  
  
  METHODS
  Risperidone long-acting injectable was administered in an open-label, single-dose, two-way crossover study, with patients randomized to receive either 25mg gluteal/37.5mg deltoid crossover in two treatment periods or 50mg gluteal/50mg deltoid injections crossover; each treatment period was separated by an 85-day observation period (Study 1) and an open-label, multiple-dose study (4 sequential 37.5mg or 50mg deltoid injections every 2 weeks) (Study 2). The pharmacokinetic results from both the studies have already been published.
  
  
  RESULTS
  In Study 1 (n=170), the majority of patients had no local injection-site findings, based on investigator and patient-rated evaluations. In Study 2 (n=53), seven of the 51 patients who received at least two deltoid injections discontinued (primary endpoint). However, none of the discontinuations were due to injection-site related reasons. The 90-percent upper confidence limit of the true proportion of injection-site issue withdrawals was 5.7 percent. No moderate or severe injection-site reactions were reported.
  
  
  CONCLUSIONS
  Intramuscular injections via the deltoid and gluteal sites are equivalent routes of administration of risperidone long-acting injectable with respect to local injection-site tolerability. The overall safety and tolerability profile of risperidone long-acting injectable was comparable when administered as an intramuscular injection in the deltoid (37.5mg and 50mg) and gluteal (25mg and 50mg) sites.
authors.affiliation: Central Nervous System, Pain and Translational Medicine Therapeutic Area at Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, New Jersey, USA.
authors.forename: Jorge A
authors.initials: JA
authors.lastname: Quiroz
authors.forename: Sarah
authors.initials: S
authors.lastname: Rusch
authors.forename: An
authors.initials: A
authors.lastname: Thyssen
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Palumbo
authors.forename: Stuart
authors.initials: S
authors.lastname: Kushner