One of the most interesting candidates in
) pipeline is aripiprazole lauroxil for schizophrenia. The
candidate performed well in a phase III study. Results from the
study were presented by the company at the American Society of
Clinical Psychopharmacology. 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
Data from the study during the double-blind treatment period
revealed statistically and clinically significant reduction in
patients' total scores compared to placebo on the Positive and
Negative Syndrome Scale (PANSS) following 12 weeks of treatment
with aripiprazole lauroxil across both the evaluated doses. With
this the candidate met the primary objective of the study. PANSS, a
psychiatric scale, measures the symptom severity in schizophrenia.
Furthermore, treatment with aripiprazole lauroxil resulted in
improvement from baseline in the Clinical Global Impression -
Improvement Scale at week 12. All other key secondary endpoints of
the study were also met. The candidate was found to be well
tolerated in the study. Alkermes stated in its press release that
all patients who participated in the study were eligible to
continue with aripiprazole lauroxil for an additional 12 months to
asses the safety and long-term durability of the treatment.
Aripiprazole lauroxil, an atypical antipsychotic, is converted into
aripiprazole once it enters into the patient's body. We note that
aripiprazole is marketed by
Bristol-Myers Squibb Company
)/ Otsuka under the trade name Abilify.
Encouraged by the positive phase III data, Alkermes intends to seek
U.S. approval of the schizophrenia candidate in the third quarter
of 2014.The approval would boost Alkermes' top line since the
schizophrenia market offers significant commercial potential.
Alkermes is also evaluating aripiprazole lauroxil so that it can be
dosed once every two months.
Alkermes, a biopharmaceutical company, carries a Zacks Rank #3
(Hold). Better-ranked biopharma stocks include
). Both the stocks carry a Zacks Rank #1 (Strong Buy).
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