Alkermes Announces Schizophrenia Therapy Studies

A phase 3b clinical study will look into the safety and efficacy of what could be 2 crucial bridging therapies for schizophrenia patients.

Aripiprazole lauroxil (ARISTADA) from Alkermes is being investigated as a possible extended-release injectable suspension, as well as paliperidone palmitate (INVEGA SUSTENNA) in patients with acute exacerbation of schizophrenia. Aripiprazole lauroxil is currently approved for the treatment of schizophrenia in 441 mg, 662 mg, 882 mg, and 1064 mg doses.

The announced randomized, multicenter, double-blind, phase 3b trial will seek the efficacy and safety of both therapies in about 180 patients suffering acute exacerbation of schizophrenia. Patients will be randomized into either treatment group for 6 total treatment months, with an endpoint of change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at week 4.

ARISTADA therapy will be initiated to patients with the recent US Food and Drug Administration (FDA)-submitted novel device Aripiprazole Lauroxil NanoCrystal Dispersion (ALNCD) before receiving ARISTADA 30 mg for another 2 months.

Elliot Ehrich, MD, executive vice president of Research and Development for Alkermes, said the use of ALNCD to initiate 2-month ARISTADA prior to schizophrenia patient discharge “represents an innovative approach to treating schizophrenia, and one we believe has the potential to significantly change the treatment paradigm.”

“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.

A recurring issue in schizophrenia patient populations is treatment non-adherence, Alejandro Kopelowicz, MD, professor and vice-chair in the Department of Psychiatry and Biobehavioral Sciences at the David Geffen School of Medicine at UCLA, told MD Magazine. The investigational therapies are designed to circumvent that issue.

Schizophrenia patients can suffer from re-hospitalization in only a matter of days if they suffer from lapses of treatment, Kopelowicz said. This is a particular issue when they are being transitioned from inpatient to outpatient care.

The injected ALNCD, provided with a 30 mg oral dose of aripiprazole, could provide a proper transition therapy before patients begin the projected once-monthly treatments of ARISTADA.

“That is a major accomplishment,” Kopelowicz said. “The most risky period of a patient having decompensation is the 30 days following their discharge. Unfortunately, their psychotic episodes are extremely sensitive to medications.”

The Alkermes study, projected to begin in November, is preceded by a phase 4 clinical study that showed patients who switched therapy to ARISTADA after failing to have adequate response or tolerance to INVEGA SUSTENNA reported statistically significantly and clinically meaningful improvement in schizophrenia symptom at the end of 6 months.

Further successful results may answer the long-held hope from clinicians for a once-monthly or twice-monthly injection treatment, Kopelowicz said.

While the investigational therapy process may be capable of steadying patient status at a quicker rate before beginning injection treatment, Kopelowicz advocated for better treatment integration, and communication between the inpatient and outpatient facilities that treat schizophrenia patients.

Alkermes may have uncovered “just one approach to minimize all the possible way things can fall apart,” Kopelowicz said.

A press release regarding the trials was made available.