— Once-Monthly Injectable Medicine
Significantly Improved Schizophrenia Symptoms —
— Multiple Dose Strengths May Offer Flexibility
To Address Individual Patient Needs —
— Data from Study Served as Basis for NDA
Filing With FDA Action Date of Aug. 22, 2015 —
Alkermes plc (NASDAQ: ALKS) today announced the publication of
results from its phase 3 clinical trial of aripiprazole lauroxil
for the treatment of schizophrenia in the Journal of Clinical
Psychiatry. Data from the trial showed that multiple dose strengths
of aripiprazole lauroxil administered once monthly demonstrated
statistically significant reductions in schizophrenia symptoms,
compared to placebo. Aripiprazole lauroxil is an investigational,
novel, long-acting injectable atypical antipsychotic for the
treatment of schizophrenia designed to offer patients an
alternative to oral antipsychotic medicines that must be taken
daily. Aripiprazole lauroxil was developed based on Alkermes’
proprietary LinkeRx® technology and is designed to provide dosing
flexibility to address the unique needs of patients with
schizophrenia. Once in the body, aripiprazole lauroxil converts to
aripiprazole, a molecule that is commercially available under the
name ABILIFY®. Results of the study served as the basis for
Alkermes’ New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) to gain marketing approval of aripiprazole
lauroxil for the treatment of schizophrenia, with a regulatory
action date of Aug. 22, 2015.
“This published study adds to the body of evidence that is
influencing the evolution of the treatment landscape for
schizophrenia, as more physicians are now recognizing the potential
benefits of long-acting injectable antipsychotics and considering
their use earlier in disease progression,” said study author Henry
Nasrallah, M.D., Chair, Department of Neurology and Psychiatry at
Saint Louis University School of Medicine. “These statistically
significant efficacy data demonstrated aripiprazole lauroxil’s
ability to provide clinically meaningful symptom control, showing
its potential as a new treatment option to help people with
schizophrenia.”
The phase 3, randomized, multicenter, double-blind,
placebo-controlled study of aripiprazole lauroxil evaluated 623
patients with schizophrenia. Patients treated once monthly with
either 441 mg or 882 mg of aripiprazole lauroxil demonstrated
statistically significant reductions from baseline in Positive and
Negative Syndrome Scale (PANSS) total scores at Week 12, compared
to placebo. The improvement from baseline to Week 12 in PANSS total
scores was clinically meaningful and statistically significant in
both aripiprazole lauroxil dose groups, with a placebo-adjusted
mean PANSS score reduction of 10.9 points for the 441 mg dose group
(p<0.001) and 11.9 points for the 882 mg dose group
(p<0.001). In addition to meeting the prespecified primary
efficacy endpoint of PANSS total score reduction, the study also
met the prespecified key secondary endpoint of improvement on the
Clinical Global Impression – Improvement (CGI-I) scale for each
aripiprazole lauroxil group versus placebo at Week 12 (p<0.001).
Both of the aripiprazole lauroxil dosing groups demonstrated
significant improvement at all post-baseline visits. Furthermore,
all other secondary endpoints were found to be statistically
significant across both doses.
Aripiprazole lauroxil was generally well tolerated in the phase
3 study. The most common adverse events in the study were insomnia,
akathisia and headache.
“Schizophrenia is a serious, chronic disease, and healthcare
providers need new, innovative treatment options to address the
individual needs of patients,” said Elliot Ehrich, M.D., Chief
Medical Officer of Alkermes. “Aripiprazole lauroxil is designed to
help address the real-world, individual needs of patients and
healthcare providers by providing dosing flexibility in a
ready-to-use format.”
Study Design
The phase 3, randomized, multicenter, double-blind,
placebo-controlled study was designed to assess the efficacy,
safety and tolerability of aripiprazole lauroxil in patients
experiencing acute exacerbation of schizophrenia. The trial
included adult patients who met the Diagnostic and Statistical
Manual of Mental Disorders, Fourth Edition, Text Revision
(DSM-IV-TR®) criteria for schizophrenia and had a PANSS total score
of 70 or higher at study baseline.
A total of 623 patients were randomized to receive once-monthly
intramuscular injections of aripiprazole lauroxil 441 mg,
aripiprazole lauroxil 882 mg or a matching placebo injection of
either low volume or high volume for 12 weeks. Following
randomization, patients received their first injection along with
daily oral study drug for the first three weeks. Patients
randomized to the two aripiprazole lauroxil treatment groups
received oral aripiprazole for those initial three weeks, while
patients randomized to the placebo group received matching oral
placebo for three weeks. A total of 596 patients were included in
the full analysis set, as defined by those who received at least
one dose of study drug and had at least one primary efficacy
assessment following administration of study drug.
The primary efficacy endpoint of the study was the mean change
from baseline at Week 12 in PANSS total score, using an analysis of
covariance (ANCOVA) with a last observation carried forward (LOCF)
approach. The Hommel procedure was used for multiple hypothesis
testing. Efficacy was also analyzed using a mixed model for
repeated measures (MMRM) as a sensitivity analysis.
All participants in the double-blind portion of the study were
eligible to continue in an open-label phase and receive
aripiprazole lauroxil for an additional 12 months. The objective of
the extension phase of the study is to assess the safety and
long-term durability of effect of once-monthly aripiprazole
lauroxil.
About Aripiprazole
Lauroxil
Aripiprazole lauroxil is an injectable atypical antipsychotic
with one-month and extended-duration 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®. As a long-acting investigational
medication based on Alkermes’ proprietary LinkeRx® 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, which is 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 developing innovative medicines for the treatment of
central nervous system (CNS) diseases. The company has a
diversified commercial product portfolio and a substantial clinical
pipeline of product candidates for chronic diseases that include
schizophrenia, depression, addiction and multiple sclerosis.
Headquartered in Dublin, Ireland, Alkermes plc has an R&D
center in Waltham, Massachusetts; a research and manufacturing
facility in Athlone, Ireland; and a manufacturing facility in
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: the company’s
expectations and timeline for regulatory action by the FDA relating
to the NDA submission for aripiprazole lauroxil for the treatment
of schizophrenia; and the potential therapeutic value, attributes,
and 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 expressed or implied 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 by Aug. 22, 2015 or at all; 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 Annual Report on Form 10-K for the fiscal year ended Dec. 31,
2014, and in any 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® is a registered trademark of Alkermes Pharma Ireland
Limited. ABILIFY® is a registered trademark of Otsuka
Pharmaceutical Co., Ltd. DSM-IV-TR® is a registered trademark of
the American Psychiatric Association.
1National Alliance on Mental Illness. Accessed on June 8, 2015
from
http://www.nami.org/Learn-More/Mental-Health-Conditions/Schizophrenia.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.
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Alkermes Contacts:For
Investors:Rebecca Peterson, +1 781 609 6378orFor Media:Jennifer
Snyder, +1 781 609 6166
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