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Study expands dosing options for Aristada

Data presented at the International Congress on Schizophrenia Research indicated a higher dose of Aristada may be safe and effective for a two-month dose interval, potentially expanding dosing options of aripiprazole treatments.

“Schizophrenia is a complex condition in which symptoms and severity of the disease varies, and healthcare providers need a variety of options to help individualize treatment based on patient needs,” Elliot Ehrich, MD, chief medical officer of Alkermes, said in a press release. “We are designing Aristada to offer unprecedented flexibility in terms of doses and dosing intervals, and we believe a two-month offering of Aristada could be an important new treatment option for the treatment of schizophrenia.”

To evaluate Aristada (aripiprazole lauroxil, Alkermes) in different dosing scenarios, researchers updated an existing pharmacokinetic model of aripiprazole lauroxil to include data from five clinical studies, including a completed phase 1 open-label study assessing pharmacokinetics, safety and tolerability of 441, 882, or 1,064 mg of aripiprazole lauroxil at 4-, 6-, and 8-week intervals. Analysis included data for 700 individuals with schizophrenia.

The final pharmacokinetic model assessed an 8-week regimen of aripiprazole lauroxil compared with already approved regimens (441, 662 and 882 mg monthly and 882 mg every 6 weeks), impact of missed doses and reinitiation of treatment every 8 weeks following a delay in dosing.

Repeated dosing simulations indicated 1,064 mg of aripiprazole lauroxil every 8 weeks produced aripiprazole concentrations that were associated with efficacy.

Median simulated steady-state concentrations of aripiprazole in the 8-week regimen (154 ng/ml, 165 ng/ml and 183 ng/ml) were comparable to 882 mg every 6 weeks and 662 mg monthly regimens.

Aripiprazole concentrations slowly decreased when a dose was delayed, decreasing by less than 20% for a 14-day delay within an 8-week regimen. Concentrations returned to expected levels when aripiprazole lauroxil dosing resumed.

“Given the wide spectrum of symptoms and severity associated with schizophrenia, clinicians often need a variety of treatment options to find the right medication regimen that works for their patients,” Peter J. Weiden, MD, senior medical director at Alkermes, and professor at Northwestern University School of Medicine, told Healio/Psychiatry. “With Aristada, a long-acting antipsychotic medication, clinicians and patients have additional dosing options. Aristada currently has two dosing interval options: medication given by injection once every month or once every six weeks. This potential two-month dosing interval, if approved, would expand the range of Aristada dose intervals for use by clinicians and patients in treating schizophrenia. Some patients may benefit from having their Aristada injection interval once every two months.” – by Amanda Oldt

Reference:

Hard ML, et al. Pharmacokinetic analysis of a 2-month regimen of aripiprazole lauroxil. Presented at: International Congress on Schizophrenia Research; March 24-28, 2017; San Diego.

Disclosure: Hard reports holding stock and employment with Alkermes. Please see the study for a full list of relevant financial disclosures.