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Alkermes Starts Phase I Study on Schizophrenia Candidate - Analyst Blog

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Alkermes plc ( ALKS ) has started a phase I study of extended dosing intervals on aripiprazole lauroxil. Aripiprazole lauroxil, a long-acting injectable atypical antipsychotic, is currently under FDA review for the treatment of schizophrenia.

The randomized, open-label study will assess the pharmacokinetics, safety and tolerability of aripiprazole lauroxil when administered over new extended durations - at one month, six-week and two-month intervals. Following a 30-day screening period, approximately 140 patients with stable schizophrenia will receive one of four different dosing regimens of aripiprazole lauroxil (441 mg once a month, 882 mg every six weeks or one of two formulations of 1064 mg every two months) over a period of six months.

Alkermes expects results from the phase I study on aripiprazole lauroxil in mid-2016.

According to data provided by the National Institutes of Health, schizophrenia is estimated to affect 2.4 million adults in the U.S. Once developed and approved, the extended-duration formulation will provide patients with additional treatment and dosing options.

We are encouraged by Alkermes' progress with aripiprazole lauroxil. A reponse from the FDA regarding the once-monthly formulation of aripiprazole lauroxil is expected by Aug 22, 2015. Aripiprazole lauroxil's approval would boost Alkermes' top line since the schizophrenia market offers significant commercial potential.

We expect investor focus to remain on updates pertaining to the candidate.

Alkermes currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Amgen Inc. ( AMGN ), ANI Pharmaceuticals, Inc. ( ANIP ) and Biogen Idec Inc. ( BIIB ). All three carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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