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Alkermes submits NDA for Aristada dispersion product
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Alkermes recently announced submission of a New Drug Application for aripiprazole lauroxil NanoCrystal Dispersion, an investigational product designed for initiation to Aristada extended-release injectable suspension, for treatment of schizophrenia.
“The NanoCrystal Dispersion system greatly reduces the transition period from oral to [long-acting injectable] antipsychotics. Individuals given the [NanoCrystal Dispersion] formulation require only one dose of oral aripiprazole to reach a therapeutic blood level within 24 hours, thus providing practitioners with more confidence that patients will arrive at their first outpatient appointment in a clinically stable state,” Alex Kopelowicz, MD, of the David Geffen School of Medicine at University of California, Los Angeles, told Healio.com/Psychiatry. “Given all of the obstacles to continuity of care faced by patients and their families when navigating the complex mental health system, eliminating the problem of medication non-adherence during the transition from inpatient to outpatient treatment is an important achievement.”
NanoCrystal technology is designed to provide extended-release Aristada (aripiprazole lauroxil, Alkermes) using a smaller particle size intended to enable faster dissolution and more rapid achievement of therapeutic levels of aripiprazole.
If approved, NanoCrystal Dispersion used in conjunction with a single 30-mg oral dose of aripiprazole may replace the need for 3 weeks of concomitant oral aripiprazole with the first dose of Aristada.
NanoCrystal Dispersion is designed for initiation of any dose or duration of Aristada.
Alkermes also announced initiation of a phase 3b clinical study to assess efficacy and safety of Aristada extended-release injectable suspension and Invega Sustenna (paliperidone palmitate, Alkermes) among approximately 180 patients with acute exacerbation of schizophrenia.
Participants randomly assigned to receive aripiprazole lauroxil will receive NanoCrystal Dispersion followed by a 2-month dose of aripiprazole lauroxil for six months.
Participants randomly assigned to receive a starting dose of paliperidone palmitate followed by monthly treatment for 6 months.
Researchers will determine change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 4 and at the end of the 6-month treatment.
“This study evaluating Aristada alongside Invega Sustenna, a medicine which is recognized in the medical community as a highly effective therapeutic option for schizophrenia, will provide helpful insight into the utility of these treatment options,” Ehrich said in the release. “The use of aripiprazole lauroxil NanoCrystal Dispersion to initiate onto 2-month Aristada prior to hospital discharge represents an innovative approach to treating schizophrenia, and one we believe has the potential to significantly change the treatment paradigm.”
Alkermes projects the study will begin in November 2017.