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This study was published as several abstracts and presented
at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Note that a phase III study was halted at a preplanned
interim data point which demonstrated fewer relapses with depot aripiprazole compared with placebo for long-term maintenance in schizophrenia.
Note that the drug appeared well-tolerated with similar
numbers of discontinuations due to adverse events in the
PHILADELPHIA -- A depot formulation of aripiprazole (Abilify) is on track to join the ranks of long-
acting antipsychotic drugs that don't need to be taken daily, reports here suggested.
Results of a placebo-controlled phase III trial indicated that depot aripiprazole effectively prevented relapses after patients had been stabilized on daily oral doses of the drug, with no adverse effects beyond those expected with aripiprazole, according to John Kane, MD, of Hofstra North Shore-Long
The trial, which had enrolled 710 patients, was stopped when 344 had been in the randomized maintenance-therapy phase long enough to be evaluated for impending relapse, the trial's primary
At that point, a preplanned interim analysis conducted after the 64th relapse showed a clear clinical benefit for the depot product relative to placebo -- 9.6% of patients receiving depot aripiprazole showed signs of impending relapse compared with 36.8% of the placebo group (hazard ratio 4.7, 95% CI 2.8 to 7.9).
Impending relapse was defined as any of four events: symptom worsening according to Clinical Global Impression scores, hospitalization for psychotic symptoms, risk of suicide, or violent behavior resulting
In a final analysis conducted on 403 patients who entered the randomized maintenance phase, more than 70% of the placebo group relapsed compared with approximately 20% of those receiving the
active drug in about one year of follow-up.
Serious adverse events were rare, recorded in 4.1% of patients assigned to aripiprazole for the
randomized maintenance phase versus 6.7% of the placebo group.
Tremor was the only common treatment-emergent adverse effect seen more often with aripiprazole than placebo (5.9% versus 1.5%). Rates of discontinuation due to adverse effects during the
randomized phase were virtually the same in both groups.
In the trial, patients with a recent history of schizophrenic episodes were first put on oral aripiprazole over a 4 to 6 week period, then stabilized on a fixed dose for an additional 4 to 12 weeks. At that point, all patients (576 of the original 710) were placed on the depot aripiprazole, administered
monthly by injection in the buttock, for 3 to 9 months.
Finally, patients were randomized 2:1 to continue on the depot aripiprazole or switch to placebo on a
Several depot antipsychotics are already available: haloperidol, fluphenazine, risperidone (Risperdal),
paliperidone (Invega), and olanzapine (Zyprexa).
Marcus Graff, MD, a psychiatrist who recently left the Kaiser Permanente system to work in the Los
Angeles County health department, said it's helpful to have additional options.
Many patients do better on one antipsychotic drug than others, said Graff, who was not involved with the study. So when a depot product is indicated -- usually but not always to improve compliance -- it's preferable to keep the patient on the same drug he or she was taking orally, rather than switch to
another agent that may not work as well.
Graff said a depot agent may sometimes be effective when the oral version of the same drug was not.
A patient may not absorb the oral drug well, for example.
Normally, though, a depot drug is considered when patients won't take oral medications regularly, said John Lauriello, MD, of the University of Missouri in Columbia, who was not involved with the
In such cases, "long-acting injectables are the most likely thing that people will try," he said.
He said safety has never been a major problem with depot products. Rather, the main barrier has
Graff told MedPage Today
that the injection can be painful -- the products are viscous and require a
large-gauge needle -- and not every patient wants to drop his or her pants to be treated.
Lauriello said another factor is that patients may perceive the injections as surrendering control, or as
punishment for failing to take oral medications on schedule.
Depot aripiprazole's manufacturer, Otsuka, and its marketing partner Lundbeck have applied for FDA
approval. A decision is expected by the end of July.
Kane reported consulting or other relationships with MedAvante, Alkermes, Amgen, Bristol-Myers Squibb, Cephalon, Boehringer Ingelheim, Lilly, Janssen, Johnson & Johnson, Lundbeck, Merck,
Novartis, Otsuka, Pfizer, Pierre Fabre, and Proteus.
Graff had no relevant financial interests.
Lauriello reported relationships with Sunovion and Lilly.
Kane J, et al "Efficacy of aripiprazole-intramuscular-depot for the long-term maintenance treatment of
2012; Abstract NR6-41.
Fleischhacker W, et al "Long-term safety and tolerability of one-monthly aripiprazole-intramuscular-
depot for the long-term maintenance treatment of schizophrenia" APA
2012; Abstract NR4-47.
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