) submitted a New Drug Application (NDA) for aripiprazole lauroxil
in the U.S. The company is looking to get aripiprazole lauroxil
approved for the treatment of schizophrenia. Alkermes shares gained
almost 2.3% on the news.
The company's regulatory submission included results from the
pivotal phase III study on the efficacy and safety of aripiprazole
lauroxil. The randomized, multicenter, double-blind,
placebo-controlled study evaluated the efficacy, safety and
tolerability of the candidate (once a month) across two doses (441
mg and 882 mg) in patients with acute exacerbation of
Results revealed statistically and clinically significant reduction
in patients' total scores compared to placebo on the Positive and
Negative Syndrome Scale following 12 weeks of treatment with
aripiprazole lauroxil across both the evaluated doses. Moreover,
the candidate showed significant improvements in schizophrenia
symptoms in comparison to placebo. Aripiprazole lauroxil was also
well tolerated during the study.
We are encouraged by Alkermes' progress with aripiprazole lauroxil.
Alkermes is also evaluating aripiprazole lauroxil for a once every
two months dose. The candidate will enter a lucrative schizophrenia
market on approval which is expected to boost Alkermes' top line.
As per National Institutes of Health (as of Aug. 22, 2014) there
are around 2.4 million adults in the U.S. suffering from
schizophrenia. However, the schizophrenia market currently has
companies like Novartis (
) and Eli Lilly and Company (
Alkermes, a biopharmaceutical company, carries a Zacks Rank #4
(Sell). A better-ranked stock in the health care space is Gilead
) sporting a Zacks Rank #1 (Strong Buy).
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