Alkermes Begins Schizophrenia Clinical Trial Of Extended Duration Aripiprazole Lauroxil
By C. Rajan, contributing writer
Dublin-based drugmaker Alkermes has announced that it will begin a phase 1 clinical trial to investigate the effect of extended dosing intervals of aripiprazole lauroxil on schizophrenia.
The randomized, open-label Phase 1 study will evaluate the pharmacokinetics, safety, and tolerability of aripiprazole lauroxil dosed once every six weeks and once every two months. These two new longer duration injectable doses are designed to give more flexibility to patients and doctors than currently available options.
Alkermes has already developed a one-month formulation of aripiprazole lauroxil successfully. A New Drug Application (NDA) for the drug is currently under review with the U.S. FDA and has been assigned a Prescription Drug User Fee Act (PDUFA) date of Aug. 22, 2015.
Alkermes submitted the NDA for the once-monthly formulation of aripiprazole lauroxil in August this year, based on positive results from the phase 3 study assessing the efficacy and safety of the drug.
In this new study for six-week and two-month doses, approximately 140 patients with schizophrenia will be treated with aripiprazole lauroxil at one-month, six-week, and two-month intervals. The patients with stable schizophrenia will be randomized to receive one of four different dosing regimens of aripiprazole lauroxil (441 mg once per month, 882 mg every six weeks, or 1064 mg every two months) for a total of six months of treatment. Alkermes expects to have the results from this study by mid-2016.
“Building upon our longstanding expertise with multiple long-acting atypical antipsychotics available today, Alkermes recognizes the value of flexibility of dosing for both patients and healthcare providers. Our goal is to continue to move the frontier by creating the first long-acting atypical antipsychotic designed to be dosed every six weeks or every two months,” said Elliot Ehrich, M.D., CMO of Alkermes. “We believe there are compelling needs in the mental illness community to improve treatment outcomes for patients, and our aim is to continue to apply our innovative technology to bring forward options for the treatment of schizophrenia.”
Aripiprazole, an atypical antipsychotic drug, is a dopamine D2 partial agonist. Oral aripiprazole is marketed under the name Abilify by Otsuka Pharmaceutical and Lundbeck, and it was the best-selling drug in 2013 with sales of nearly $6.5 billion. Alkermes’ drug, aripiprazole lauroxil, is formulated as a long-acting injectable (LAI), which gradually converts into aripiprazole in the body. According to Alkermes, aripiprazole lauroxil will have multiple dosing options administered in a ready-to-use, pre-filled product format.
Schizophrenia is a serious mental illness characterized by hallucinations, depression, and disorganized thinking. According to Alkermes, an estimated 2.4 million American adults have schizophrenia, and about one person in every 100 develops schizophrenia globally.