Aripiprazole Lauroxil Shows Promise in Late-Stage Schizophrenia Trial

Promising data from a phase III study of aripiprazole lauroxil (Alkermes LLC), an investigational drug candidate in development for the treatment of schizophrenia, have been presented at the American Society of Clinical Psychopharmacology (ASCP) annual meeting in Hollywood, Florida.

In the pivotal trial, both doses of aripiprazole lauroxil (441 mg and 882 mg), administered once-monthly, met the primary endpoint, achieving statistically significant reductions in Positive and Negative Syndrome Scale (PANSS) scores compared with placebo. The study also met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms with aripiprazole lauroxil.

A new drug application is expected to be submitted to the FDA in the third quarter of 2014.

In the trial, 623 patients with acute exacerbation of schizophrenia were randomly assigned to receive once-monthly intramuscular injections of aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg, or matching placebo for 12 weeks. After randomization, patients received their first injection along with daily oral study drug for the first 3 weeks.

Patients assigned to the two aripiprazole lauroxil treatment groups received oral aripiprazole for those initial 3 weeks, whereas patients assigned to the placebo group received matching oral placebo for 3 weeks. A total of 596 patients were included in the full analysis set, defined as those who received at least one dose of study drug and had at least one primary efficacy assessment after the administration of study drug.

During the 12-week, double-blind treatment period, the patients treated once monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically and clinically significant placebo-adjusted mean reductions from baseline in PANSS total scores (–10.9 points, P < 0.001 for aripiprazole lauroxil 441 mg; and –11.9 points, P < 0.001 for aripiprazole lauroxil 882 mg).

In addition to meeting its prespecified primary efficacy endpoint, the study also met the prespecified key secondary endpoint of improvement on the Clinical Global Impression—Improvement (CGI-I) scale for each aripiprazole lauroxil group versus placebo at week 12 (P < 0.001).

Both of the aripiprazole lauroxil dosing groups demonstrated significant improvement at all post-baseline visits. In addition, all other secondary endpoints were found to be statistically significant across both doses.

The most common adverse events associated with the active treatment were insomnia, akathisia, and headache.


what the hell is late-stage Sz? sounds like more propganda for a drug company to make a buck, but these folks aren’t cured yet, it’s probably their immune system causing the problem…

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I’m personally always happy to see a new treatment option available. But the primary side effects with this one are going to be tough for patients to manage. These types of side effects often lead to treatment dropout or treatment non-compliance.

I wouldn’t be able to handle them, that’s for sure!

Thanks for sharing!



Exactly what I thought.

Truth is a person can experience a gradual onset of symptoms and then they subside on their own… some even go away entirely without meds or doctors.

It does work, but it causes weight gain that’s the major side effect. I went to their updated website for Abilify, and I would say it’s all very accurate. I would assume the main risks: somnolence, fatigue/agitation, weight gain, pregnant or nursing women/passes into breastmilk.

It is known to cause skeletal birth defects on rats and bunnies, lower weight gain, increased infertility, stillbirth, and abortion. You can’t breastfeed unless you want to risk that. 10mgs is the highest dose if you ever get pregnant and choose to keep taking it for bipolar or schizophrenia. There have been no known or recorded deaths by overdose of abilify.

It’s relatively the safest and most effective drug available for schizophrenia.

It is not used as a monotherapy for MDD or depression. It might help alongside another drug but appears to be known ineffective on its own for depression. On its own for mania and schizophrenia it works really well though for me.

It increases risk of suicide in preteens who have depression.

Disagree…or what about when given for non SZ diagnoses?

Now are they telling us just pre teens? It used to be teens and young adults.

I knew my wife was young at heart and even when she was in her 30s got asked if she went to high school.

Of course at the real age of 40 after starting Abilify and her cutting, taking an OD and eventual suicide I guess doesn’t count for their mislabeling…
I cannot totally fault the med though as the therapist was also greatly to blame for lack of proper monitoring and other violations when prescribing it…

when someone can stop my immune system from attacking my own body, then I’ll be impressed.

It’s safer as far as known physical side effects like NMS, TD, diabetes, etc. It is not supposed to be used on its own for depression. I didn’t mean to upset you with my comment.

I simply can’t seem to get off Abilify now. I can’t handle the withdrawal. It makes me too sick. I get chest pains, anxiety, start crying non-stop, get weird colds/flu symptoms.

Abilify is also causing my shallow breathing and hiccups.

You didnt upset me personally…I’m not upset with you…I am upset with what happened with the total mismanagement of my wifes case though, as you know…
It wasn’t on its own…Abilify was added to what she had already been on a few months: Xanax, Wellbutrin and Remeron.
I forget if they replaced Wellbutrin with Abilify or if she took all 4 at once, but i know for sure she was taking the Xanax, Remeron and Abilify together…