-- ALKS 9070 Is Designed to Offer Best-in-Class, Extended-Release, Once-Monthly Version of Aripiprazole --
“Multiple studies have shown that long-acting therapies in the treatment of schizophrenia can lead to improved patient outcomes and reduced costs,” stated Dr.
In
“Alkermes’ expertise in developing safe and effective long-acting therapeutics uniquely positions us to develop a once-monthly atypical antipsychotic medication that delivers aripiprazole, a widely prescribed oral product with an established safety and efficacy profile,” stated Dr.
Phase 3 Study Design
The phase 3 randomized, multicenter, double-blind study is designed to assess the efficacy, safety and tolerability of ALKS 9070 compared to placebo in patients experiencing acute exacerbation of schizophrenia. Approximately 690 subjects will be randomized to receive once-monthly intramuscular injections of ALKS 9070 300 mg, ALKS 9070 600 mg or placebo for twelve weeks. In addition, subjects will receive oral study drug for the first three weeks after randomization. Subjects randomized to one of the two ALKS 9070 treatment groups will receive oral aripiprazole, while subjects randomized to the placebo group will receive matching oral placebo. The primary efficacy endpoint of the study is the change in Positive and Negative Syndrome Scale (PANSS) total score from baseline. All participants in the double-blind portion of the study will be eligible to continue in an open-label phase and receive ALKS 9070 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 ALKS 9070.
About LinkeRx™ and ALKS 9070
LinkeRx is a novel, proprietary technology platform that enables the creation of injectable extended-release atypical antipsychotics and other CNS therapies. ALKS 9070, which leverages the LinkeRx technology, is a once-monthly, injectable atypical antipsychotic in development for the treatment of schizophrenia. Once in the body, ALKS 9070 converts to aripiprazole. Aripiprazole is commercially available under the name ABILIFY® for the treatment of a number of CNS disorders.
About Schizophrenia
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, 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.
About
Note Regarding Forward-Looking Statements
Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the continued clinical development of ALKS 9070 for the treatment of schizophrenia and the therapeutic value and potential of ALKS 9070. 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. The company’s business is subject to significant risk and uncertainties and there can be no assurance that its actual results will not differ materially from its expectations.
These risks and uncertainties include, among others: whether preclinical and early clinical results for ALKS 9070 will be predictive of future clinical study results; whether ALKS 9070 is shown to be ineffective or unsafe during clinical studies; decisions by the
LinkeRx™ is a trademark of
Source:
Alkermes plc
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