Meeting to review new Alkermes medicine


News Journal



Alkermes announced Thursday that the Nasdaq Stock Market has temporarily halted trading of the company’s ordinary shares, according to a press release from the company

The Dublin, Ireland-based company operates a facility in Wilmington.

The joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee — appointed by the U.S. Food and Drug Administration (FDA) — will meet Thursday to review the company’s New Drug Application for ALKS 5461.

ALKS 5461 is “a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies.”

According to Alkermes, “ALKS 5461 is a proprietary, investigational, once-daily oral medicine that acts as an opioid system modulator and represents a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies. ALKS 5461 is a fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist.”

According to the DSM-5 — the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition — major depressive disorder (MDD) is a condition in which patients exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and demonstrate impaired social, occupational, educational or other important functioning.

An estimated 16.2 million people in the U.S. suffered from MDD in 2016,1 the majority of whom may not adequately respond to initial antidepressant therapy.2

https://www.wnewsj.com/wp-content/uploads/sites/22/2018/11/web1_Alkermes.jpg

News Journal