— Results From Positive Phase 2 Study of ALKS
3831 for the Treatment of Schizophrenia
to be Presented —
— Long-Term Clinical Data on ARISTADA® for the
Treatment of Schizophrenia
Will Also be Highlighted —
Alkermes plc (NASDAQ:ALKS) today announced that data from
Alkermes’ schizophrenia portfolio will be featured at the 5th
Biennial Schizophrenia International Research Society (SIRS)
Conference to be held in Florence, Italy on April 2-6, 2016. In
addition to positive data from a phase 2 study of ALKS 3831, the
company’s investigational, novel, oral atypical antipsychotic drug
candidate designed to be a broad-spectrum treatment for
schizophrenia, the company will present the designs of ongoing
clinical studies of ALKS 3831, including the phase 3 pivotal
studies. Additionally, data on the long-term clinical benefits of
aripiprazole lauroxil, an extended-release injectable suspension,
will be presented. Aripiprazole lauroxil is marketed by Alkermes as
ARISTADA® and is approved in the U.S. for the treatment of
schizophrenia.
Alkermes presentations at SIRS include:
ALKS 3831
- Poster #M63, “A Phase 3 Study to
Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in
Adult Subjects With Acute Exacerbation of Schizophrenia,” will
describe the pivotal study design for ALKS 3831 during Poster
Session II at the Cavaniglia Pavilion on Monday, April 4, 2016,
11:00 a.m. – 1:00 p.m. CEST.
- Poster #M64, “A Phase 2, Efficacy,
Safety and Tolerability Study of ALKS 3831 in Schizophrenia With
Alcohol Use Disorder,” will describe the design and preliminary
patient characteristics of an ongoing study evaluating ALKS 3831 in
the treatment of patients with schizophrenia and alcohol use
disorder during Poster Session II at the Cavaniglia Pavilion on
Monday, April 4, 2016, 11:00 a.m. – 1:00 p.m. CEST.
- Poster #T63, “A Phase 3 Study to
Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults
With Schizophrenia,” will describe the pivotal study design for
ALKS 3831 during Poster Session III at the Cavaniglia Pavilion on
Tuesday, April 5, 2016, 11:00 a.m. – 1:00 p.m. CEST.
- Poster #T62, “ALKS 3831 Demonstrated
Equivalent Antipsychotic Efficacy While Addressing Weight Gain:
Results from a Phase 2, Randomized, Olanzapine-Controlled Study,”
will be available during Poster Session III at the Cavaniglia
Pavilion on Tuesday, April 5, 2016, 11:00 a.m. – 1:00 p.m.
CEST.
ARISTADA
- Poster #M61, “Stability in a 52-Week
Schizophrenia Extension Study of Treatment With Long-Acting
Injectable Aripiprazole Lauroxil,” will be available during Poster
Session II at the Cavaniglia Pavilion on Monday, April 4, 2016,
11:00 a.m. – 1:00 p.m. CEST.
- Poster #T59, “Long-Term Safety and
Durability of Effect of Aripiprazole Lauroxil in a One-Year
Schizophrenia Extension Study,” will be available during Poster
Session III at the Cavaniglia Pavilion on Tuesday, April 5, 2016,
11:00 a.m. – 1:00 p.m. CEST.
Complete abstracts and further details on the SIRS conference
are available
at:https://sirs.societyconference.com/conf/#sessions/conf10002.
About Schizophrenia
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 2.8 million American adults have schizophrenia,1, 2 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.
About ALKS 3831
ALKS 3831 is a proprietary, investigational medicine designed as
a broad-spectrum antipsychotic for the treatment of schizophrenia.
ALKS 3831 is composed of samidorphan, a novel, new molecular entity
co-formulated with the established antipsychotic agent, olanzapine,
in a single bilayer tablet.
About
ARISTADA®ARISTADA is an injectable atypical
antipsychotic with one-month and six-week dosing options for the
treatment of schizophrenia. ARISTADA is administered by a
healthcare professional. Once in the body, ARISTADA converts to
aripiprazole. ARISTADA was approved by the FDA in October 2015.
INDICATION and IMPORTANT SAFETY INFORMATION for
ARISTADA® (aripiprazole lauroxil)
extended-release injectable suspension, for intramuscular
use
INDICATION
ARISTADA is indicated for the treatment of schizophrenia.
IMPORTANT SAFETY INFORMATION
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death. ARISTADA is
not approved for the treatment of patients with dementia-related
psychosis.
Contraindication: Known hypersensitivity reaction to
aripiprazole. Reactions have ranged from pruritus/urticaria to
anaphylaxis.
Cerebrovascular Adverse Reactions, Including Stroke:
Increased incidence of cerebrovascular adverse reactions (e.g.,
stroke, transient ischemic attack), including fatalities, have been
reported in placebo-controlled trials of elderly patients with
dementia-related psychosis treated with risperidone, aripiprazole,
and olanzapine. ARISTADA is not approved for the treatment of
patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): A potentially fatal
symptom complex sometimes referred to as NMS may occur with
administration of antipsychotic drugs, including ARISTADA. Clinical
manifestations of NMS include hyperpyrexia, muscle rigidity,
altered mental status, and evidence of autonomic instability
(irregular pulse or blood pressure, tachycardia, diaphoresis, and
cardiac dysrhythmia). Additional signs may include elevated
creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute
renal failure. The management of NMS should include:
1) immediate discontinuation of antipsychotic drugs and other
drugs not essential to concurrent therapy; 2) intensive
symptomatic treatment and medical monitoring; and 3) treatment
of any concomitant serious medical problems for which specific
treatments are available.
Tardive Dyskinesia (TD): The risk of developing TD (a
syndrome of abnormal, involuntary movements) and the potential for
it to become irreversible are believed to increase as the duration
of treatment and the total cumulative dose of antipsychotic
increase. The syndrome can develop, although much less commonly,
after relatively brief treatment periods at low doses. Prescribing
should be consistent with the need to minimize TD. Discontinue
ARISTADA if clinically appropriate. There is no known treatment for
established TD, although the syndrome may remit, partially or
completely, if antipsychotic treatment is withdrawn.
Metabolic Changes: Atypical antipsychotic drugs have been
associated with metabolic changes that include:
- Hyperglycemia/Diabetes Mellitus:
Hyperglycemia, in some cases extreme and associated with
ketoacidosis, coma, or death, has been reported in patients treated
with atypical antipsychotics. There have been reports of
hyperglycemia in patients treated with oral aripiprazole. Patients
with diabetes should be regularly monitored for worsening of
glucose control; those with risk factors for diabetes should
undergo baseline and periodic fasting blood glucose testing. Any
patient treated with atypical antipsychotics should be monitored
for symptoms of hyperglycemia, including polydipsia, polyuria,
polyphagia, and weakness. Patients who develop symptoms of
hyperglycemia should also undergo fasting blood glucose testing. In
some cases, hyperglycemia has resolved when the atypical
antipsychotic was discontinued; however, some patients require
continuation of antidiabetic treatment despite discontinuation of
the suspect drug.
- Dyslipidemia: Undesirable
alterations in lipids have been observed in patients treated with
atypical antipsychotics.
- Weight Gain: Weight gain has
been observed with atypical antipsychotic use. Clinical monitoring
of weight is recommended.
Orthostatic Hypotension: Aripiprazole may cause
orthostatic hypotension which can be associated with dizziness,
lightheadedness and tachycardia. Monitor heart rate and blood
pressure, and warn patients with known cardiovascular or
cerebrovascular disease and risk of dehydration and syncope.
Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia,
neutropenia, and agranulocytosis have been reported. Patients with
a history of clinically significant low white blood cell count
(WBC)/absolute neutrophil count (ANC) and history of drug-induced
leukopenia/neutropenia should have frequent complete blood count
(CBC) during the first few months of receiving ARISTADA. Consider
discontinuation of ARISTADA at the first sign of a clinically
significant decline in WBC count in the absence of other causative
factors. Monitor patients with clinically significant neutropenia
for fever or other symptoms or signs of infection and treat
promptly if such symptoms or signs occur. Discontinue ARISTADA in
patients with severe neutropenia (absolute neutrophil count
<1000/mm3) and follow their WBC until recovery.
Seizures: ARISTADA should be used with caution in
patients with a history of seizures or with conditions that lower
the seizure threshold.
Potential for Cognitive and Motor Impairment: ARISTADA
may impair judgment, thinking, or motor skills. Patients should be
cautioned about operating hazardous machinery, including
automobiles, until they are certain ARISTADA does not affect them
adversely.
Body Temperature Regulation: Disruption of the body’s
ability to reduce core body temperature has been attributed to
antipsychotic agents. Advise patients regarding appropriate care in
avoiding overheating and dehydration. Appropriate care is advised
for patients who may exercise strenuously, may be exposed to
extreme heat, receive concomitant medication with anticholinergic
activity, or are subject to dehydration.
Dysphagia: Esophageal dysmotility and aspiration have
been associated with antipsychotic drug use; use caution in
patients at risk for aspiration pneumonia.
Concomitant Medication: Decreasing the ARISTADA dosage is
recommended in patients taking strong CYP3A4 inhibitors and/or
strong CYP2D6 inhibitors for longer than 2 weeks. Increasing the
ARISTADA dosage is recommended in patients taking CYP3A4 inducers
for longer than 2 weeks. No ARISTADA dosage changes are recommended
for patients taking CYP450 modulators for less than 2 weeks.
Most Commonly Observed Adverse Reaction: The most common
adverse reaction (≥5% incidence and at least twice the rate of
placebo in patients treated with ARISTADA) was akathisia.
Injection-Site Reactions: Injection-site reactions were
reported by 4%, 5%, and 2% of patients treated with 441 mg
ARISTADA, 882 mg ARISTADA, and placebo, respectively. Most of these
were injection-site pain and associated with the first injection
and decreased with each subsequent injection. Other injection-site
reactions (induration, swelling, and redness) occurred at less than
1%.
Dystonia Symptoms of dystonia, prolonged abnormal
contractions of muscle groups, may occur in susceptible individuals
during the first days of treatment and at low doses.
Pregnancy/Nursing: May cause extrapyramidal and/or
withdrawal symptoms in neonates with third trimester exposure.
Advise patients to notify their healthcare provider of a known or
suspected pregnancy. Inform patients that there is a pregnancy
exposure registry that monitors pregnancy outcomes in women exposed
to ARISTADA during pregnancy. Aripiprazole is present in human
breast milk. The benefits of breastfeeding should be considered
along with the mother’s clinical need for ARISTADA and any
potential adverse effects on the infant from ARISTADA or from the
underlying maternal condition.
Please see FULL PRESCRIBING INFORMATION, including
Boxed Warning for ARISTADA.
About Alkermes plc
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
StatementsCertain 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
therapeutic value of, and clinical development plans for, ALKS 3831
and the potential therapeutic and commercial value of ARISTADA for
the treatment of schizophrenia. You are cautioned 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 are subject to a variety of risks and uncertainties,
many of which are beyond the company’s control, which could cause
actual results to differ materially from those expressed or implied
in the forward-looking statements. These risks and uncertainties
include, among others, whether preclinical and clinical results for
ALKS 3831 will be predictive of future clinical study results;
whether ALKS 3831 could be shown to be unsafe or ineffective;
whether future clinical trials for ALKS 3831 will be initiated or
completed on time or at all; and those risks and uncertainties
described under the heading “Risk Factors” and elsewhere in the
Alkermes plc Annual Report on Form 10-K for the fiscal year ended
Dec. 31, 2015, and in other subsequent filings made by the company
with the 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.
ARISTADA® is a registered trademark of Alkermes Pharma Ireland
Limited
1 U.S. Census.2 National Institute of Mental
Health. Schizophrenia. Accessed on March 25,
2016 from http://www.nimh.nih.gov/health/statistics/prevalence/schizophrenia.shtml.
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Alkermes:For Investors:Sandra
Coombs, +1-781-609-6377orFor Media:Jennifer Snyder,
+1-781-609-6166
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