LONDON, UK / ACCESSWIRE / April 18, 2018 / Active-Investors.com has just released a free research report on Alkermes PLC (NASDAQ: ALKS). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ALKS as the Company's latest news hit the wire. On April 16, 2018, the Company announced that the US Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies. The FDA's target action date for the ALKS 5461 NDA is January 31, 2019. Register today and get access to over 1000 Free Research Reports by joining our site below:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Alkermes most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

www.active-investors.com/registration-sg/?symbol=ALKS

Alkermes Did Not Submit Additional Data or Analyses to the FDA

The FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued on March 30, 2018, follows productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission. The Company did not submit additional data or analyses to the FDA. The NDA filing for ALKS 5461 is based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD. Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety, and tolerability in the adjunctive treatment of MDD.

News report suggest that post announcement of the news, the shares of Alkermes surged in pre-market trade.

FDA Initially Refused to Accept NDA for ALKS 5461

On April 02, 2018, Alkermes announced that it received a Refusal to File letter from the FDA regarding its NDA for ALKS 5461 for the adjunctive treatment of MDD. The reason cited by the FDA was insufficient evidence of overall effectiveness for the proposed indication, and that additional well-controlled clinical trials were needed prior to the resubmission of the NDA for ALKS 5461. The FDA also requested the conduct of a bioavailability study to generate additional bridging data between ALKS 5461 and the reference listed drug, buprenorphine.

About Major Depressive Disorder (MDD)

MDD, also known simply as depression, is a mental disorder characterized by at least two weeks of low mood that is present across most situations. It is often accompanied by low self-esteem, loss of interest in normally enjoyable activities, low energy, and pain without a clear cause. Some people have periods of depression separated by years in which they are normal while others nearly always have symptoms present. MDD can negatively affect a person's personal, work, or school life, as well as sleeping, eating habits, and general health.

About ALKS 5461

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 MDD in patients with an inadequate response to standard antidepressant therapies. ALKS 5461 is a fixed-dose combination of buprenorphine, which is a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, which is a mu-opioid receptor antagonist. ALKS 5461 was granted a Fast Track status by the FDA in October 2013 for the adjunctive treatment of MDD.

About Alkermes PLC

Founded in 1987 and headquartered in Dublin, Ireland, Alkermes is a fully-integrated, global biopharmaceutical organization, developing innovative medicines for the treatment of central nervous system (CNS) diseases. The Company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction, and multiple sclerosis.

Stock Performance Snapshot

April 17, 2018 - At Tuesday's closing bell, Alkermes' stock climbed 4.34%, ending the trading session at $46.36.

Volume traded for the day: 2.07 million shares, which was above the 3-month average volume of 1.26 million shares.

After yesterday's close, Alkermes' market cap was at $7.31 billion.

The stock is part of the Healthcare sector, categorized under the Drug Delivery industry. This sector was up 0.9% at the end of the session.

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