– Prespecified Interim Analysis of Sample Size Indicates Study Well-Powered to Evaluate Primary Endpoint –
DUBLIN, Ireland I October 8, 2013 I Alkermes plc (NASDAQ: ALKS) today announced completion of patient enrollment in the pivotal, multinational phase 3 study evaluating aripiprazole lauroxil in patients with schizophrenia. Aripiprazole lauroxil is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY®. Alkermes continues to expect topline results from the phase 3 study in the first half of 2014.
Enrollment was completed following a prespecified interim analysis of sample size. This analysis, designed to preserve the integrity of the final efficacy analysis and performed by an independent statistical center, indicated that a sample size of 540 patients or more would have sufficient statistical power to evaluate the primary endpoint. The study continues to be blinded until completion.
“There is a clear and compelling need for long-acting injectable medicines for patients with schizophrenia,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “We are excited to complete enrollment in this carefully conducted, multinational study and look forward to reporting the results in the first half of 2014.”
The phase 3 pivotal clinical trial of aripiprazole lauroxil is a 12-week, multicenter, double-blind, placebo-controlled study designed to assess the efficacy, safety and tolerability of aripiprazole lauroxil in patients experiencing acute exacerbation of schizophrenia. The primary endpoint is the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score, which is a standard outcome measure in the evaluation of schizophrenia treatment. The clinical data from this study will form the basis of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for aripiprazole lauroxil for the treatment of schizophrenia.
About Aripiprazole Lauroxil and LinkeRx®
LinkeRx is a novel, proprietary technology platform developed by Alkermes that enables the creation of injectable extended-release atypical antipsychotics and other central nervous system therapies. Aripiprazole lauroxil, which utilizes the LinkeRx technology, is a once-monthly, injectable atypical antipsychotic in phase 3 clinical development for the treatment of schizophrenia. Once in the body, aripiprazole lauroxil converts to aripiprazole, which is commercially available under the name ABILIFY. Aripiprazole lauroxil was formerly referred to as ALKS 9070.
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 schizophrenia1, 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 Alkermes
Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and manufacturing facilities in Gainesville, Georgia and Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
SOURCE: Alkermes
Post Views: 23
– Prespecified Interim Analysis of Sample Size Indicates Study Well-Powered to Evaluate Primary Endpoint –
DUBLIN, Ireland I October 8, 2013 I Alkermes plc (NASDAQ: ALKS) today announced completion of patient enrollment in the pivotal, multinational phase 3 study evaluating aripiprazole lauroxil in patients with schizophrenia. Aripiprazole lauroxil is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY®. Alkermes continues to expect topline results from the phase 3 study in the first half of 2014.
Enrollment was completed following a prespecified interim analysis of sample size. This analysis, designed to preserve the integrity of the final efficacy analysis and performed by an independent statistical center, indicated that a sample size of 540 patients or more would have sufficient statistical power to evaluate the primary endpoint. The study continues to be blinded until completion.
“There is a clear and compelling need for long-acting injectable medicines for patients with schizophrenia,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “We are excited to complete enrollment in this carefully conducted, multinational study and look forward to reporting the results in the first half of 2014.”
The phase 3 pivotal clinical trial of aripiprazole lauroxil is a 12-week, multicenter, double-blind, placebo-controlled study designed to assess the efficacy, safety and tolerability of aripiprazole lauroxil in patients experiencing acute exacerbation of schizophrenia. The primary endpoint is the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score, which is a standard outcome measure in the evaluation of schizophrenia treatment. The clinical data from this study will form the basis of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for aripiprazole lauroxil for the treatment of schizophrenia.
About Aripiprazole Lauroxil and LinkeRx®
LinkeRx is a novel, proprietary technology platform developed by Alkermes that enables the creation of injectable extended-release atypical antipsychotics and other central nervous system therapies. Aripiprazole lauroxil, which utilizes the LinkeRx technology, is a once-monthly, injectable atypical antipsychotic in phase 3 clinical development for the treatment of schizophrenia. Once in the body, aripiprazole lauroxil converts to aripiprazole, which is commercially available under the name ABILIFY. Aripiprazole lauroxil was formerly referred to as ALKS 9070.
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 schizophrenia1, 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 Alkermes
Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and manufacturing facilities in Gainesville, Georgia and Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
SOURCE: Alkermes
Post Views: 23
