FDA Approves ARISTADA™ for Treatment of Schizophrenia
— First Long-Acting Atypical Antipsychotic With Both Once-Monthly and Six-Week Dosing Options —
— Product Features Include Range of Dose Strengths and Multiple Dosing Intervals Designed to Address Individual Patient Needs —
— Company to Host Conference Call at 7:30 a.m. EDT Tomorrow —
DUBLIN–(BUSINESS WIRE)–Oct. 5, 2015– Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved ARISTADA™ (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. ARISTADA is the first atypical antipsychotic with once-monthly and six-week dosing options for delivering and maintaining therapeutic levels of medication in the body through an injection. Alkermes is preparing to launch ARISTADA immediately.
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“ARISTADA is a new treatment option designed to offer flexibility to meet the real-world needs of patients suffering from schizophrenia and the healthcare professionals providing their care,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “Building on nearly two decades of experience developing innovative medicines for chronic and serious CNS diseases, we are dedicated to helping to improve the lives of patients as well as meeting the needs within the treatment ecosystem of caregivers, physicians, payers and society. We look forward to making ARISTADA available to patients and healthcare providers as quickly as possible.”
ARISTADA’s features, including a range of dose strengths and dosing interval options, are designed to address the individual needs of patients and challenges in the treatment of schizophrenia. As a long-acting injectable medicine, ARISTADA provides patients, clinicians and families the certainty that patients receive medication for this serious brain disorder. Long-acting injectable antipsychotics provide patients with blood concentrations of active drug that remain within a therapeutic range for an extended period of time1 and help healthcare providers to track patient adherence.2
“Schizophrenia is a serious and debilitating disease where, despite the existence of many medicines, there remains significant unmet medical need and suffering. New treatment options are needed to help patients and their families better manage this illness,” said David Henderson, M.D., Associate Professor of Psychiatry at Massachusetts General Hospital. “Long-acting therapies are rapidly evolving to the forefront of the treatment of schizophrenia as clinicians increasingly recognize the potential benefits of less frequent dosing and consider their use earlier in disease progression.”
The FDA approval of ARISTADA was based on a proven safety and efficacy profile, including data from a randomized, double-blind, placebo-controlled, phase 3 study in 623 patients with schizophrenia. Data from that trial showed that multiple dose strengths of ARISTADA met the primary endpoint with statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) total scores at Week 12, met the key secondary endpoint and demonstrated significant improvements in schizophrenia symptoms versus placebo. The most common adverse events in the study were insomnia, akathisia and headache. The results of the phase 3 study were published in June 2015 by The Journal of Clinical Psychiatry, a peer-reviewed medical journal.
Alkermes will host a conference call on Tuesday, Oct. 6, 2015, at 7:30 a.m. EDT (12:30 p.m. BST). The conference call may be accessed by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988. The conference call will also be webcast on the Investors section of Alkermes’ website at www.alkermes.com. In addition, a replay of the conference call will be available from 9:30 a.m. EDT (2:30 p.m. BST) on Tuesday, Oct. 6, 2015, through5:00 p.m. EDT (10:00 p.m. BST) on Tuesday, Oct. 13, 2015, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.
Excerpt from a Press Release on the Alkermes Investor Website