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— Once-Monthly Injectable Schizophrenia Medication Achieved Primary and Secondary Endpoints at Both Doses Tested in Pivotal Study —
— Company Plans To Submit New Drug Application in Third Quarter of 2014 —
“These statistically significant efficacy data demonstrate aripiprazole
lauroxil’s ability to provide clinically meaningful symptom control in
patients struggling with schizophrenia,” said
Data from the full analysis set showed statistically significant improvement in PANSS total scores from baseline in both aripiprazole lauroxil dose groups, relative to the placebo treatment group. In addition to meeting the prespecified primary efficacy endpoint, the study also met the prespecified key secondary endpoint of improvement on the Clinical Global Impression – Improvement scale (CGI-I) versus placebo at week 12 (p<0.001).
“Our goal has been to develop a differentiated long-acting injectable
product candidate responsive to the real-world needs of patients and
healthcare providers, providing the proven efficacy of aripiprazole
administered once-monthly in a ready-to-use format with multiple dosage
strengths,” stated Richard Pops, Chief Executive Officer of
Aripiprazole lauroxil was generally well tolerated in the phase 3 study, and the safety profile of aripiprazole lauroxil was similar to that reported with oral aripiprazole. The most common adverse events in the study were insomnia, akathisia and headache.
Phase 3 Study Design
The phase 3, randomized, multicenter, double-blind, placebo-controlled study was designed to assess the efficacy, safety and tolerability of aripiprazole lauroxil in patients experiencing acute exacerbation of schizophrenia. The trial included adult patients who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR®) criteria for schizophrenia and had a PANSS total score of 70 or higher at study baseline.
A total of 623 patients were randomized to receive once-monthly intramuscular injections of aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg or placebo for 12 weeks. Following randomization, patients received their first injection along with daily oral study drug for the first three weeks. Patients randomized to the two aripiprazole lauroxil treatment groups received oral aripiprazole for those initial three weeks, while patients randomized to the placebo group received matching oral placebo for three weeks. The primary efficacy endpoint of the study was the change from baseline at week 12 in PANSS total score, using an analysis of covariance (ANCOVA) with a last observation carried forward (LOCF). The key secondary endpoint was the CGI-I score at week 12.
All participants in the double-blind portion of the study are eligible to continue in an open-label phase and receive aripiprazole lauroxil for an additional 12 months. The objective of the extension phase of the study is to assess the safety and long-term durability of effect of once-monthly aripiprazole lauroxil.
About Aripiprazole Lauroxil
Aripiprazole lauroxil, which utilizes Alkermes’ proprietary LinkeRx® technology, is an injectable atypical antipsychotic with one-month and two-month formulations in development for the treatment of schizophrenia. Once in the body, aripiprazole lauroxil converts to aripiprazole, which is commercially available under the name ABILIFY.
About Schizophrenia and Long-Acting Medicines
Schizophrenia is a chronic, severe and disabling brain disorder. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganized thinking. An estimated 2.4 million Americans have schizophrenia,1 with men and women affected equally. Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness.
Long-acting injectable antipsychotics provide patients with blood concentrations of active drug that remain within a therapeutic range for an extended period of time2 and allow healthcare providers to track when a patient does not return for a scheduled injection.3
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, including, but not limited to,
statements concerning: the therapeutic value, development plans and
commercial potential of aripiprazole lauroxil. The company cautions that
forward-looking statements are inherently uncertain. Although the
company believes that such statements are based on reasonable
assumptions within the bounds of its knowledge of its business and
operations, the forward-looking statements are neither promises nor
guarantees and they are necessarily subject to a high degree of
uncertainty and risk. Actual performance and results may differ
materially from those projected or suggested in the forward-looking
statements due to various risks and uncertainties. These risks and
uncertainties include, among others: regulatory submissions may not
occur or be submitted in a timely manner; adverse decisions by
regulatory authorities may occur; the company may be unable to
commercially manufacture aripiprazole lauroxil successfully; and those
risks described in the
DSM-IV-TR® is a registered trademark of the
2Patel MX and David AS. Why aren't depot antipsychotics prescribed more often and what can be done about it? Adv Psychiatr Treat, 2005; 11: 203-213.
3Kane JM et al. Guidelines for depot antipsychotic treatment in schizophrenia. Eur Neuropsychopharmacol, 1998; 8(1): 55-66.
Rebecca Peterson, +1 781-609-6378
Jennifer Snyder, +1 781-609-6166