Alkermes Announces Initiation of Clinical Study of Extended Durations of Aripiprazole Lauroxil for Treatment of Schizophrenia
December 15 2014 - 7:00AM
Business Wire
— Potential To Give Patients and Physicians a
New, Long-Acting Injectable Medicine With More Flexibility in
Dosing Intervals, Beyond Once-Monthly Aripiprazole Lauroxil —
Alkermes plc (NASDAQ: ALKS) today announced the initiation of a
phase 1 clinical study of extended dosing intervals of aripiprazole
lauroxil, the company’s investigational, novel, long-acting
injectable atypical antipsychotic for the treatment of
schizophrenia. The randomized, open-label study of approximately
140 patients with schizophrenia will evaluate the pharmacokinetics,
safety and tolerability of aripiprazole lauroxil administered over
two new extended durations – once every six weeks, and once every
two months. A New Drug Application (NDA) for aripiprazole lauroxil
one-month is currently under review with the U.S. Food and Drug
Administration (FDA) and has been assigned a Prescription Drug User
Fee Act (PDUFA) date of Aug. 22, 2015.
“Building upon our longstanding expertise with multiple
long-acting atypical antipsychotics available today, Alkermes
recognizes the value of flexibility of dosing for both patients and
healthcare providers. Our goal is to continue to move the frontier
by creating the first long-acting atypical antipsychotic designed
to be dosed every six weeks or every two months,” said Elliot
Ehrich, M.D., Chief Medical Officer of Alkermes. “We believe there
are compelling needs in the mental illness community to improve
treatment outcomes for patients, and our aim is to continue to
apply our innovative technology to bring forward options for the
treatment of schizophrenia.”
The phase 1, randomized, open-label study will evaluate the
pharmacokinetics, safety and tolerability of aripiprazole lauroxil
when administered at one-month, six-week and two-month intervals.
Following a 30-day screening period, approximately 140 patients
with stable schizophrenia will be randomized to receive one of four
different dosing regimens of aripiprazole lauroxil (441 mg once per
month, 882 mg every six weeks, or one of two formulations of 1064
mg every two months) for a total of six treatment months. Results
from this phase 1 study are expected mid 2016.
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 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: the company’s
expectations and timeline for regulatory action by the FDA relating
to the NDA for aripiprazole lauroxil one-month for the treatment of
schizophrenia; the potential therapeutic value, attributes and
commercial potential of aripiprazole lauroxil one-month and
extended-duration formulations of aripiprazole lauroxil; and the
clinical development timelines of extended-duration formulations 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 preclinical and early clinical
results for aripiprazole lauroxil will be predictive of future
clinical study results; whether future clinical trials for
aripiprazole lauroxil will be completed on time or at all; changes
in the cost, scope and duration of the aripiprazole lauroxil
clinical trials; whether aripiprazole lauroxil could be shown
ineffective or unsafe; whether aripiprazole lauroxil one-month 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; 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® is a registered trademark of Alkermes Pharma Ireland
Limited. ABILIFY® is a registered trademark of Otsuka
Pharmaceutical Co., Ltd.
1National Institutes of Health. Accessed on Dec. 12, 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.
Alkermes Contacts:Alkermes plcFor
Investors:Rebecca Peterson, +1-781-609-6378orFor Media:Jennifer
Snyder, +1-781-609-6166
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