Breaking News

Alkermes Provides Late-Stage CNS Pipeline Update

By Kristin Brooks | January 8, 2014

Phase III programs advance

Alkermes plc has reported new developments in its late-stage central nervous system (CNS) pipeline. The company has added aripiprazole lauroxil two-month, which is currently in Phase III development, to its portfolio of atypical antipsychotics for the treatment of schizophrenia. If approved, aripiprazole lauroxil two-month would be the first long-acting atypical antipsychotic medication dosed every two months.
 
In addition, Alkermes’ Phase III program for ALKS 5461, a Fast Track-designated drug being evaluated for the treatment of major depressive disorder (MDD) in patients who have had an inadequate response to standard therapies, is expected to begin in 1Q14.
 
“As we begin 2014, Alkermes is aggressively executing on our strategy of building and advancing one of the most exciting CNS pipelines in the industry; one characterized by its potential value to patients and treatment systems,” said Richard Pops, chief executive officer of Alkermes.
 
“Schizophrenia and major depressive disorder are chronic diseases that affect the daily lives of millions of patients and are conditions where new treatment options with novel mechanisms of action and new dosing regimens are needed,” said Elliot Ehrich, M.D., chief medical officer of Alkermes. “Clinicians who treat patients with schizophrenia and major depression need better treatment options to achieve stable remission in these serious, chronic conditions. Our goal is to advance clinical care by addressing unmet medical needs with aripiprazole lauroxil and ALKS 5461.”

blog comments powered by Disqus
  • Cold Chain Packaging Trends

    Cold Chain Packaging Trends

    Kristin Brooks, Contract Pharma||February 4, 2016
    Susan Li of UPS discusses supply chain trends, challenges, and packaging innovations

  • Packaging Equipment Trends Preview

    Packaging Equipment Trends Preview

    Kristin Brooks, Contract Pharma||January 26, 2016
    Christian Treitel of Bosch Packaging Technology discusses trends and capabilities

  • Filings Update

    Filings Update

    December 1, 2015
    Roche, Pfizer, Janssen, BMS and more

  • Elemental Impurity Testing

    Elemental Impurity Testing

    Dr. Andrew Fussell, PANalytical ||January 28, 2016
    Advances in elemental impurity testing aid compliance with new USP requirements

  • Fit-For-Purpose Assay Development in Bioanalysis

    Fit-For-Purpose Assay Development in Bioanalysis

    Franklin Spriggs, Ligand Binding Assay Group Leader; Ashley Brant, Program Manager, AIT Bioscience||January 28, 2016
    The success of bioanalytical studies relies on the selection of the most suitable analytical method but the timeline of method development and types of analyses involved vary greatly.

  • Optimizing Collaboration Effectiveness in Alliance Partnerships

    Optimizing Collaboration Effectiveness in Alliance Partnerships

    Mary Jo Lamberti, Phil Birch, Ranjana Chakravarthy, Ken Getz, Tufts CSDD||January 28, 2016