乌鸦传媒

NEW YORK CITY -- An investigational 1-day aripiprazole initiation regimen was comparable in efficacy to usual treatment, according to a phase I study presented here.

For the treatment of schizophrenia, patients who received the 1-day initiation regimen of the injectable antipsychotic aripiprazole lauroxil (Aristada) had comparable exposure to the treatment compared with patients who received the usual 21-day initiation regimen that includes oral aripiprazole supplementation, reported David Walling, PhD, CEO and principal investigator for CNS Network, a clinical research provider in Southern California, and colleagues.

As described in the study, presented at the annual meeting of the American Psychiatric Association, the 1-day treatment, which is administered in a hospital setting, included just one injection of a novel nano-crystalline milled dispersion of aripiprazole lauroxil in combination with one oral dose of 30 mg aripiprazole. The treatment regimen achieved similar concentrations of aripiprazole in patients compared with the usual 21-day treatment regimen of 15 mg per day of oral aripiprazole.

"One of the issues with some of the long-acting medications is that you have to supplement them with oral medications for a period of time beforehand," Walling explained to 乌鸦传媒. "So for that 3-week period of time, the patients have to take oral medications, as well as an injection at the start of that period. The problem with that is -- particularly for patients with acute episodic schizophrenia -- that they leave the hospital and stop taking their oral medications, so then they don't actually reach the levels that they need to in order to stabilize their illness."

"What we were looking for was a way to essentially start patients on medications faster and reduce the complexity of the regimen for the patients so that it's easier for them when they go out into the community."

The blinded, pharmacokinetic study included 133 patients who completed the study. Participants were randomized (1:1:1:1) to receive the investigational 1-day treatment or the usual 21-day treatment plus a 441-mg or 882-mg dose of aripiprazole lauroxil. The nano-sized particle in the investigational treatment allows for faster dissolution, allowing for faster achievement of target therapeutic levels of the treatment with only one dose, Walling noted.

The investigational treatment was also well tolerated overall, with the most common adverse events being pain at the injection site, anxiety, insomnia, weight gain, and dyspepsia. There were also nine akathisia events reported among the cohort -- with four events occurring in the 1-day treatment and five events occurring in the usual-treatment groups.

The 1-day treatment is currently under review for approval by the FDA, with a decision expected by the end of next month.

"As we know, schizophrenia is a complex disease. By having the 1-day option, it reduces the burden on caregivers, it reduces the burden on patients, and it gives clinicians ease of mind in knowing patients have the medication," Walling concluded.

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