— Potential To Give Patients and Physicians a New, Long-Acting Injectable Medicine With More Flexibility in Dosing Intervals, Beyond Once-Monthly Aripiprazole Lauroxil —
DUBLIN, Ireland I December 15, 2014 I Alkermes plc (NASDAQ: ALKS) today announced the initiation of a phase 1 clinical study of extended dosing intervals of aripiprazole lauroxil, the company’s investigational, novel, long-acting injectable atypical antipsychotic for the treatment of schizophrenia. The randomized, open-label study of approximately 140 patients with schizophrenia will evaluate the pharmacokinetics, safety and tolerability of aripiprazole lauroxil administered over two new extended durations – once every six weeks, and once every two months. A New Drug Application (NDA) for aripiprazole lauroxil one-month is currently under review with the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) date of Aug. 22, 2015.
“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., Chief Medical Officer 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.”
The phase 1, randomized, open-label study will evaluate the pharmacokinetics, safety and tolerability of aripiprazole lauroxil when administered at one-month, six-week and two-month intervals. Following a 30-day screening period, approximately 140 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 one of two formulations of 1064 mg every two months) for a total of six treatment months. Results from this phase 1 study are expected mid 2016.
About Aripiprazole Lauroxil
Aripiprazole lauroxil is an injectable atypical antipsychotic with one-month and extended-duration 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®. As a long-acting investigational medication based on Alkermes’ proprietary LinkeRx® technology, aripiprazole lauroxil is designed to have multiple dosing options and to be administered in a ready-to-use, pre-filled product format.
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 American adults have schizophrenia,1 with men and women affected equally. Worldwide, it is estimated that one person in every 100 develops schizophrenia, which is 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 patient adherence.3
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: 88
— Potential To Give Patients and Physicians a New, Long-Acting Injectable Medicine With More Flexibility in Dosing Intervals, Beyond Once-Monthly Aripiprazole Lauroxil —
DUBLIN, Ireland I December 15, 2014 I Alkermes plc (NASDAQ: ALKS) today announced the initiation of a phase 1 clinical study of extended dosing intervals of aripiprazole lauroxil, the company’s investigational, novel, long-acting injectable atypical antipsychotic for the treatment of schizophrenia. The randomized, open-label study of approximately 140 patients with schizophrenia will evaluate the pharmacokinetics, safety and tolerability of aripiprazole lauroxil administered over two new extended durations – once every six weeks, and once every two months. A New Drug Application (NDA) for aripiprazole lauroxil one-month is currently under review with the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) date of Aug. 22, 2015.
“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., Chief Medical Officer 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.”
The phase 1, randomized, open-label study will evaluate the pharmacokinetics, safety and tolerability of aripiprazole lauroxil when administered at one-month, six-week and two-month intervals. Following a 30-day screening period, approximately 140 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 one of two formulations of 1064 mg every two months) for a total of six treatment months. Results from this phase 1 study are expected mid 2016.
About Aripiprazole Lauroxil
Aripiprazole lauroxil is an injectable atypical antipsychotic with one-month and extended-duration 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®. As a long-acting investigational medication based on Alkermes’ proprietary LinkeRx® technology, aripiprazole lauroxil is designed to have multiple dosing options and to be administered in a ready-to-use, pre-filled product format.
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 American adults have schizophrenia,1 with men and women affected equally. Worldwide, it is estimated that one person in every 100 develops schizophrenia, which is 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 patient adherence.3
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: 88
