) pipeline has broadened significantly following its acquisition of
the erstwhile Elan's drug delivery unit in 2011. Elan was
subsequently acquired by
) late last year. Interesting candidates at Alkermes include
aripiprazole lauroxil, ALKS 3831 (schizophrenia) and ALKS 5461
(major depressive disorder).
Alkermes is working actively to develop its pipeline. In fact, the
company has reported several pipeline related news so far this
year. We also expect quite a few pipeline related updates in the
remainder of the year.
Earlier this week Alkermes announced the commencement of a 15-month
phase II trial (n~450) on ALKS 3831. ALKS 3831 is a combination of
samidorphan (formerly ALKS 33) and
Eli Lilly and Company
) antipsychotic drug Zyprexa (olanzapine).
Alkermes intends to evaluate the efficacy, safety and tolerability
of the candidate in patients suffering from schizophrenia versus
Zyprexa in this study. The patients also have an alcohol use
disorder. The goal of the randomized, double-blind,
active-controlled study is to compare the exacerbation of symptoms
due to alcohol use disorder in schizophrenia patients across the
two cohorts. Top-line results from the study should be out in mid
Alkermes stated in its press release that more than 33% of
schizophrenia patients also suffer from an alcohol use disorder.
However, the population is often left out from clinical trials and
is widely undertreated.
We note that this study is the second part of a phase II program on
ALKS 3831. The first phase of the program has been underway since
Jul 2013. The first phase is evaluating the attenuation of weight
gain associated with Zyprexa in schizophrenia patients.
ALKS 3831 had performed encouragingly in phase I. Results from the
study, unveiled in May 2013, showed that weight gain in patients
who were administered ALKS 3831 for three weeks was significantly
lower (an average of 2.5 kg) than in patients who took Zyprexa (an
average of 3.4 kg).
The company stated in its press release that weight gain is a
common side effect in atypical antipsychotic medications with
Zyprexa being associated with the highest occurrence as well as
magnitude of weight gain in this class of drugs.
Alkermes, a biopharmaceutical company, carries a Zacks Rank #3
) is a better-ranked stock, sporting a Zacks Rank #1 (Strong
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