Company News »

Alkermes Submits New Drug Application to FDA for Aripiprazole Lauroxil for Treatment of Schizophrenia

Business Wire
Share on StockTwits
Published on

Alkermes
plc
(NASDAQ:ALKS) today announced that it has submitted a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) for
approval of aripiprazole lauroxil, the company’s investigational, novel,
once-monthly, long-acting injectable atypical antipsychotic for the
treatment of schizophrenia. The data submitted as part of this NDA
include the positive results from the pivotal phase 3 study assessing
the efficacy and safety of aripiprazole lauroxil, in which aripiprazole
lauroxil demonstrated significant improvements in schizophrenia
symptoms, compared to placebo.

“We have designed aripiprazole lauroxil to be a differentiated treatment
option for schizophrenia, with a ready-to-use format with multiple
dosing options, to help meet the individual needs of patients and their
healthcare providers,” stated Richard Pops, Chief Executive Officer of
Alkermes. “These attributes, together with the robust clinical data
observed in the pivotal study, position aripiprazole lauroxil to be a
meaningful new entrant in the growing long-acting injectable
antipsychotic market, and we look forward to working with the FDA to
bring this important new medication to patients and physicians as
quickly as possible.”

The NDA submission follows the completion of the randomized,
multicenter, double-blind, placebo-controlled, phase 3 study, in which
both doses of aripiprazole lauroxil tested, 441 mg and 882 mg
administered once monthly, met the primary endpoint with statistically
significant and clinically meaningful reductions in Positive and
Negative Syndrome Scale (PANSS) scores, met all secondary endpoints and
demonstrated significant improvements in schizophrenia symptoms versus
placebo. Aripiprazole lauroxil was generally well tolerated in the
study, and the observed safety profile of aripiprazole lauroxil was
similar to that reported with oral aripiprazole. The most common adverse
events in the study were insomnia, akathisia and headache.

About Aripiprazole Lauroxil

Aripiprazole lauroxil is an injectable atypical antipsychotic with
one-month and two-month formulations in development for the treatment of
schizophrenia. Once in the body, aripiprazole lauroxil converts to
aripiprazole, which is commercially available under the name ABILIFY(R).
As a long-acting investigational medication based on Alkermes’
proprietary LinkeRx(R) technology, aripiprazole lauroxil is
designed to have multiple dosing options and to be administered in a
ready-to-use, pre-filled product format.

About Schizophrenia and Long-Acting Medicines

Schizophrenia is a chronic, severe and disabling brain disorder. The
disease is marked by positive symptoms (hallucinations and delusions)
and negative symptoms (depression, blunted emotions and social
withdrawal), as well as by disorganized thinking. An estimated 2.4
million American adults have schizophrenia,1 with men and
women affected equally. Worldwide, it is estimated that one person in
every 100 develops schizophrenia, one of the most serious types of
mental illness. Long-acting injectable antipsychotics provide patients
with blood concentrations of active drug that remain within a
therapeutic range for an extended period of time2 and allow
healthcare providers to track patient adherence.3

About Alkermes

Alkermes plc is a fully integrated, global biopharmaceutical company
that applies its scientific expertise and proprietary technologies to
develop innovative medicines that improve patient outcomes. The company
has a diversified portfolio of more than 20 commercial drug products and
a substantial clinical pipeline of product candidates that address
central nervous system (CNS) disorders such as addiction, schizophrenia
and depression. Headquartered in Dublin, Ireland, Alkermes plc has an
R&D center in Waltham, Massachusetts; a research and manufacturing
facility in Athlone, Ireland; and manufacturing facilities in
Gainesville, Georgia and Wilmington, Ohio. For more information, please
visit Alkermes’ website at www.alkermes.com.

Note Regarding Forward-Looking Statements

Certain statements set forth in this press release constitute
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including, but not
limited to, statements concerning: decisions by the FDA relating to the
NDA submission for aripiprazole lauroxil for the treatment of
schizophrenia and its potential therapeutic value, and the commercial
potential of aripiprazole lauroxil. The company cautions that
forward-looking statements are inherently uncertain. Although the
company believes that such statements are based on reasonable
assumptions within the bounds of its knowledge of its business and
operations, the forward-looking statements are neither promises nor
guarantees and they are necessarily subject to a high degree of
uncertainty and risk. Actual performance and results may differ
materially from those projected or suggested in the forward-looking
statements due to various risks and uncertainties. These risks and
uncertainties include, among others: whether aripiprazole lauroxil will
be approved by regulatory authorities for the treatment of
schizophrenia; if approved, whether aripiprazole lauroxil will be
commercialized successfully; whether aripiprazole lauroxil could be
shown ineffective or unsafe; and those risks described in the Alkermes
plc Transition Report on Form 10-K for the fiscal period ended Dec. 31,
2013, and in other subsequent filings made by the company with the U.S.
Securities and Exchange Commission (SEC), which are available on the
SEC’s website at www.sec.gov.
The information contained in this press release is provided by the
company as of the date hereof, and, except as required by law, the
company disclaims any intention or responsibility for updating or
revising any forward-looking information contained in this press release.

LinkeRx(R) is a registered trademark of Alkermes Pharma Ireland
Limited. ABILIFY(R) is a registered trademark of Otsuka
Pharmaceutical Co., Ltd.

1National Institutes of Health. Accessed on Aug. 22, 2014
from http://report.nih.gov/NIHfactsheets/ViewFactSheet.aspx?csid=67&key=S#S.

2Patel MX and David AS. Why aren’t depot antipsychotics
prescribed more often and what can be done about it? Adv Psychiatr
Treat
, 2005; 11: 203-213.

3Kane JM et al. Guidelines for depot antipsychotic treatment
in schizophrenia. Eur Neuropsychopharmacol, 1998; 8(1):
55-66.

Share on StockTwits