Alkermes (ALKS) 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 schizophrenia.
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 (NVS) and Eli Lilly and Company (LLY).
Alkermes, a biopharmaceutical company, carries a Zacks Rank #4 (Sell). A better-ranked stock in the health care space is Gilead Sciences (GILD) sporting a Zacks Rank #1 (Strong Buy).