ALKS 5461 is one of the most interesting candidates in
) pipeline which has expanded significantly following the
) Elan Drug Technologies unit. ALKS 5461 is a combination of ALKS
33 and buprenorphine. The candidate is being developed for major
depressive disorder (MDD).
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Alkermes has progressed well with the development of ALKS 5461.
The U.S. Food and Drug Administration (FDA) has granted fast
track status to the candidate for treating MDD patients.
The FDA assigns fast-track status to products that are being
developed for the treatment of serious or life-threatening
diseases which have an unmet medical need. The designation helps
to speed up the review process of the candidate.
Earlier in the month, the company completed its end-of- phase II
interactions with the FDA. Following the successful completion of
the interactions, the company intends to start evaluating the
candidate in major depressive disorder patients who have
responded inadequately to standard treatments for the disease
early next year.
As a result of the communications, Alkermes and the U.S.
regulatory body agreed on the key elements of the phase III
program, including its design. The written communications proved
to be sufficient for the 2 parties to come to an agreement.
Consequently, a meeting was not necessary.
Aripiprazole lauroxil (formerly known as ALKS 9070) is another
interesting candidate in Alkermes' pipeline. The company has
completed enrolling patients in a phase III study on the
candidate. The 12-week, multicenter study will be evaluating the
efficacy, safety and tolerability of aripiprazole lauroxil in
patients who experience acute exacerbation of schizophrenia.
Successful development and subsequent commercialization of
aripiprazole lauroxil would boost Alkermes' top line since the
schizophrenia market offers significant commercial potential.
Alkermes currently carries a Zacks Rank #3 (Hold). Companies like
Isis Pharmaceuticals, Inc.
) appear to be better placed with a Zacks Rank #1 (Strong