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November 10, 2016

Report: Alkermes’ ALKS-5461 to emerge as key player in major depressive disorder market

Positive results from a Phase III study on Alkermes’ ALKS-5461 shows promise towards the development of a new treatment for major depressive disorder (MDD), according to a report by GlobalData.

Positive results from a Phase III study on Alkermes’ ALKS-5461 shows promise towards the development of a new treatment for major depressive disorder (MDD), according to a report by GlobalData.

Titled 'PharmaPoint: Major Depressive Disorder – Global Drug Forecast and Market Assessment to 2025', the report provides prospects and forecasts of the MDD market.

Alkermes’ ALKS-5461 is one of six late-stage products with the potential to improve safety and efficacy in MDD patients.

The drug was granted fast-track status by the Food and Drug Administration (FDA) in October 2013, which will facilitate and expedite its regulatory review process.

"The drug was granted fast-track status by the Food and Drug Administration (FDA) in October 2013, which will facilitate and expedite its regulatory review process."

Existing drugs available for the treatment of MDD utilise selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors. However, they are ineffective in nearly one-third of patients or treatment-resistant patients as they do not demonstrate remission of symptoms. ALKS-5461 is targeted at this subset of patients and is expected to be launched in the US market in 2018.

Patient uptake of the drug, however, is expected to be impacted by the less positive outcomes of previous phase III trials.

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In addition, the drug is expected to face significant competition from other emerging pipeline therapies such as Janssen’s esketamine or Allergan’s rapastinel, which have demonstrated efficacy in treatment-resistant patients.

Furthermore, ALKS-5461’s mechanism of action through the opioid system may increase the risk of dependency and have an impact on patient uptake. Such risks, however, may be dismissed through clinical data demonstrating the absence of any difference between abuse potential between ALKS-5461 and placebo, adds the report.

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