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Alkermes Commences Metabolic Study on Schizophrenia Drug

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Alkermes plc (ALKS - Free Report) announced that it has initiated a phase I study to evaluate the metabolic effects of its experimental schizophrenia candidate, ALKS 3831. The randomized, double-blind, parallel-group study will assess the effects of ALKS 3831 on insulin sensitivity, lipid metabolism and other important metabolic parameters, in comparison to Eli Lilly and Company’s (LLY - Free Report) Zyprexa (olanzapine).

In the study, about 50 healthy subjects will receive ALKS 3831, Zyprexa or placebo for 21 days. Data from the study is anticipated in the first half of 2017.

We note that this metabolic study is a supportive study in the ENLIGHTEN pivotal program being conducted on ALKS 3831 for the treatment of schizophrenia. The program comprises two key phase III studies – ENLIGHTEN-1 and ENLIGHTEN-2 – that are currently enrolling patients. Alkermes plans to use safety and efficacy data from the ENLIGHTEN pivotal program, which would form the basis for a regulatory filing in the U.S., subject to study results.


We are encouraged by Alkermes’ progress with the candidate. Once successfully developed and subsequently approved, ALKS 3831 is expected to provide a new treatment option for schizophrenia and address the issue of significant weight gain and metabolic concerns that are usually associated with antipsychotic treatments, including Zyprexa.

As per National Institutes of Health, an estimated 2.4 million adults suffer from schizophrenia in the U.S. The press release also states that 1 in every 100 individuals are estimated to develop this mental illness across the world.

Meanwhile, Alkermes is also evaluating ALKS 3831 in a phase II study for the treatment of schizophrenia in patients, whose disease is worsened by alcohol use disorders. This group represents over one-third of patients with schizophrenia.

Zacks Rank & Stocks to Consider

Alkermes currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Anika Therapeutics Inc. (ANIK - Free Report) , and VIVUS Inc. (VVUS - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

For 2016, Anika witnessed a 9.5% increase in its earnings estimates over the past 60 days. It has recorded an average positive earnings surprise of 42.19% over the last four trailing quarters. The company’s shares have jumped almost 25% year to date.

VIVUS has recorded an average positive surprise of 39.88% over the trailing four quarters. Share price of the company gained 7.5% year to date.

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