) announced that it has completed enrolling patients in a phase
III study on its pipeline candidate aripiprazole lauroxil
(formerly known as ALKS 9070). The 12-week, multicenter study
will be evaluating the efficacy, safety and tolerability of
aripiprazole lauroxil in patients who experience acute
exacerbation of schizophrenia.
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Alkermes completed enrolling patients only after a prespecified
interim analysis was conducted by an independent statistical
center on the study's sample size. The analysis hinted that a
sample size of atleast 540 patients would have enough statistical
power to adequately assess the primary endpoint of the study. The
primary objective of this placebo-controlled study is the change
in Positive and Negative Syndrome Scale score from baseline.
Alkermes expects to report top line data from the study, which
will be blinded till it is completed, in the first half of the
next year. Alkermes expects to seek U.S. approval for
aripiprazole lauroxil in the schizophrenia indication on the
basis of data from the phase III study.
The candidate aims to provide patients with a drug (once-monthly)
which on entering the body is converted into aripiprazole. We
note that aripiprazole is marketed by
Bristol-Myers Squibb Company
) under the trade name Abilify.
Successful development and subsequent commercialization of
aripiprazole lauroxil would boost Alkermes' top line since the
schizophrenia market offers significant commercial potential.
We are pleased with the company's efforts to develop its
pipeline. Apart from aripiprazole lauroxil, other interesting
candidates at Alkermes include ALKS 5461 (a combination of ALKS
33 and buprenorphine) for major depressive disorder, ALKS 3831
(schizophrenia) and a three-month formulation of Invega sustenna.
Alkermes is also advancing the development of the early-stage
candidates in its pipeline.
Alkermes currently carries a Zacks Rank #3 (Hold). Companies like
Isis Pharmaceuticals, Inc.
) appear to be better placed with a Zacks Rank #1 (Strong