David Walling, PhD, discussed the results from a pharmacokinetic and safety study that evaluated aripiprazole lauroxil NanoCrystal Dispersion therapy initiation.
David Walling, PhD, the CEO of the Collaborative Neuroscience Network, sat down with MD Magazine at the American Psychiatric Association’s (APA) annual meeting in New York City to discuss the results from a pharmacokinetic and safety study that evaluated aripiprazole lauroxil (Aristada, Alkermes) NanoCrystal Dispersion, a novel and investigational product designed for initiation onto the therapy.
The method was tested in a clinical trial of 133 patients with schizophrenia, randomizing them 1:1:1:1 to a 1-day initiation regimen of the nano-crystalline milled dispersion plus a 30-mg dose of oral aripiprazole, or the standard approach of injection of aripiprazole lauroxil at a dose of either 441 or 882 mg plus 21 daily 15-mg doses of oral aripiprazole.
Ultimately, the method was well-tolerated, with the most common adverse events (occurring in ≥5% of patients) were injection-site pain, headache, increased weight, insomnia, dyspepsia, and anxiety. The findings were presented in a poster at the APA’s annual meeting.
Walling talked about how, importantly, this new delivery method allows for physicians to improve treatment adherence for patients with schizophrenia, who normally struggle greatly with keeping the medications they require in their systems.
David Walling, PhD:
With many of the long-acting injectable antipsychotics, you have to supplement them for 3 weeks with oral medication. So, what we did was actually look at a way that did not require the same oral supplementation, but where you could initiate subjects on the medication in 1 day. So rather than having to worry about a patient who's in an acute episode of psychosis needing to take oral medication after you've given them a long-acting injectable, instead, we can do everything in the 1 day.
We start subjects with aripiprazole lauroxil, which is Aristada, as well as give them a 30-mg tablet of aripiprazole. Then, [we] also give them a faster dissolving version of aripiprazole, so that essentially, we get them to [the correct] blood levels within a day or 2, rather than needing to wait that 3 weeks for the patient to get to the appropriate level.
Aripiprazole is a medication that's been around for a while— actually I think we started doing studies with it in the 1990s—so it's not a new mechanism of action for the drug itself, but what [Alkermes has] done, is they've come up with a nanocrystal delivery system, which sounds really exotic or kind of sci-fi, but it's really not. It really has to do with the size of the molecule, and because of this nanocrystal dissolution, the molecule, or the medication, actually dissolves in the body a little bit faster and that's how we're able to get those blood levels very quickly.
I think that what we did is exciting because it gives you comfort in knowing that your subject is getting the medication that they need prior to them leaving the hospital, or if they're in the clinic and you're concerned about them maybe not taking their medication or being compliant, this is a way that you can actually get the medication into their system very quickly.
There wasn't anything that we weren't expecting to find, but that's actually a good thing in this particular trial because the way that this came about was the [pharmacokinetic] scientists at Alkermes, they have these [computer models]—and it's becoming much more common to do this computer modeling [that they did to] come up with what they expect the ranges to be when we give the medications. I think what's really exciting is this was exactly where they expected it to be, so the computer models actually worked out with what we saw in the clinic, which is really good. I think that's another way of moving medicine forward [and] we're seeing more and more of those kinds of computer models, and when they bear out, it shows that it really works.
Transcript edited for clarity.
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