— New Safety and Tolerability Data to Be Presented From
ALPINE Study of ARISTADA® and INVEGA
SUSTENNA® in Patients With Schizophrenia —
DUBLIN, May 22, 2019 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today announced plans to present new data from its
mental health portfolio at the American Society of Clinical
Psychopharmacology (ASCP) 2019 Annual Meeting in Scottsdale, Ariz., May
28-31, including new safety and tolerability data from
ALPINE (Aripiprazole Lauroxil and Paliperidone
palmitate: INitiation Effectiveness), underscoring
the clinical utility of ARISTADA® (aripiprazole
lauroxil) and long-acting therapies for schizophrenia. ALPINE was a
first-of-its-kind, six-month study evaluating the efficacy, safety
and tolerability of ARISTADA and INVEGA SUSTENNA®
(paliperidone palmitate) when used to initiate patients
experiencing an acute exacerbation of schizophrenia in the hospital
and maintain treatment in an outpatient setting.
"Alkermes is one of very few companies focused on advancing
science in mental health, and we're committed to developing and
delivering medicines that help address the real-world challenges
that patients and providers face," said Craig Hopkinson, M.D., Chief Medical Officer and
Senior Vice President of Medicines Development and Medical Affairs
at Alkermes. "We look forward to sharing this new research with our
peers at ASCP and continuing to develop new therapies for patients
with serious and complex mental health diseases."
The full list of Alkermes presentations at ASCP includes:
- Oral Presentation: "Particle Size Matters: Developing a 1-Day
Initiation Regimen for Aripiprazole Lauroxil" will be presented by
Peter Weiden, M.D., Alkermes, during
the panel "New and Hopefully Improved! Novel Delivery Systems of
Antipsychotic Medications for the Treatment of Schizophrenia" on
Tuesday, May 28, 2019, 9:00 a.m. MT
- Oral Presentation: "A Combination of Olanzapine and Samidorphan
for Schizophrenia: Effects on Weight Gain and Metabolic Parameters
in the Phase 3 ENLIGHTEN-2 Study and Subsequent Long-Term,
Open-Label Safety Study," will be presented by John Newcomer, M.D., South Florida Behavioral
Health Network during the Pharmaceutical Pipelines session
on Tuesday, May 28, 2019, 1:50 – 4:00
p.m. MT. An accompanying poster (#W12) will be presented
on Wednesday, May 29, 2019, 11:15
a.m. – 1:00 p.m. MT
- Poster #W4: "The ALPINE Study: A Randomized, Double-Blind,
Active-Controlled Study of Starting Aripiprazole Lauroxil with a
1-Day Initiation Regimen in Acutely Ill Patients with
Schizophrenia" will be presented by Peter
Weiden, M.D., Alkermes, on Wednesday,
May 29, 2019, 11:15 a.m. –
1:00 p.m. MT
- Poster #W16: "A Phase 3, Multicenter Study to Assess the
Long-Term Safety, Tolerability and Efficacy of ALKS 3831 in
Subjects With Schizophrenia" will be presented by Sergey Yagoda, M.D., Ph.D., Alkermes, on
Wednesday, May 29, 2019, 11:15 a.m. – 1:00 p.m.
MT
- Poster #T5: "Insulin Sensitivity and Glucose Metabolism of
Olanzapine and A Combination of Olanzapine and Samidorphan: Phase 1
Study in Healthy Volunteers" will be presented by William Martin, Ph.D., Alkermes, on Thursday, May 30, 2019, 12:30 – 2:00 p.m. MT
A full list of presentations at the ASCP 2019 Annual Meeting is
available at: https://ascpmeeting.org/.
About ARISTADA®
ARISTADA is an injectable
atypical antipsychotic approved in four doses and three dosing
durations for the treatment of schizophrenia (441 mg, 662 mg or 882
mg monthly, 882 mg once every six weeks and 1064 mg once every two
months). Once in the body, ARISTADA converts to aripiprazole.
About ARISTADA INITIO®
ARISTADA INITIO, in
combination with a single 30 mg dose of oral aripiprazole, can be
used to initiate onto any dose of ARISTADA. The first ARISTADA dose
may be administered on the same day as ARISTADA INITIO or up to 10
days thereafter.
About ALKS 3831
ALKS 3831 is an investigational, novel, once-daily, oral atypical
antipsychotic drug candidate 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.
INDICATION and IMPORTANT SAFETY INFORMATION for ARISTADA
INITIO® (aripiprazole lauroxil) and
ARISTADA® (aripiprazole lauroxil) extended-release
injectable suspension, for intramuscular use
INDICATION
ARISTADA INITIO, in combination with oral aripiprazole, is
indicated for the initiation of ARISTADA when used for the
treatment of schizophrenia in adults.
ARISTADA is indicated for the treatment of schizophrenia in
adults.
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 INITIO and ARISTADA are
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 INITIO and
ARISTADA are not approved for the treatment of patients with
dementia-related psychosis.
Potential for Dosing and Medication
Errors: Medication errors, including substitution and
dispensing errors, between ARISTADA INITIO and ARISTADA could
occur. ARISTADA INITIO is intended for single administration
in contrast to ARISTADA which is administered monthly, every
6 weeks, or every 8 weeks. Do not substitute ARISTADA INITIO for
ARISTADA because of differing pharmacokinetic profiles.
Neuroleptic Malignant Syndrome (NMS): A potentially
fatal symptom complex may occur with administration of
antipsychotic drugs, including ARISTADA INITIO and 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 antipsychotics should be consistent with the
need to minimize TD. Discontinue ARISTADA if clinically
appropriate. TD 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.
Pathological Gambling and Other Compulsive
Behaviors: Compulsive or uncontrollable urges to gamble
have been reported with use of aripiprazole. Other compulsive urges
less frequently reported include sexual urges, shopping, binge
eating and other impulsive or compulsive behaviors which may result
in harm for the patient and others if not recognized. Closely
monitor patients and consider dose reduction or stopping
aripiprazole if a patient develops such urges.
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.
Falls: Antipsychotics including ARISTADA INITIO and
ARISTADA may cause somnolence, postural hypotension or motor and
sensory instability which may lead to falls and subsequent
injury. Upon initiating treatment and recurrently, complete
fall risk assessments as appropriate.
Leukopenia, Neutropenia, and
Agranulocytosis: Leukopenia, neutropenia and
agranulocytosis have been reported with antipsychotics. Monitor
complete blood count in patients with pre-existing low white blood
cell count (WBC)/absolute neutrophil count or history of
drug-induced leukopenia/neutropenia. Discontinue ARISTADA INITIO
and/or ARISTADA at the first sign of a clinically significant
decline in WBC and in severely neutropenic patients.
Seizures: Use with caution in patients with a
history of seizures or with conditions that lower the seizure
threshold.
Potential for Cognitive and Motor
Impairment: ARISTADA INITIO and ARISTADA may impair
judgment, thinking, or motor skills. Patients should be cautioned
about operating hazardous machinery, including automobiles, until
they are certain therapy with ARISTADA INITIO and/or 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: ARISTADA INITIO is only available
at a single strength as a single-dose pre-filled syringe, so dosage
adjustments are not possible. Avoid use in patients who are known
CYP2D6 poor metabolizers or taking strong CYP3A4 inhibitors, strong
CYP2D6 inhibitors, or strong CYP3A4 inducers, antihypertensive
drugs or benzodiazepines.
Depending on the ARISTADA dose, adjustments may be recommended
if patients are 1) known as CYP2D6 poor metabolizers and/or 2)
taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or
strong CYP3A4 inducers for greater than 2 weeks. Avoid
use of ARISTADA 662mg, 882mg, or 1064 mg for patients taking both
strong CYP3A4 inhibitors and strong CYP2D6 Inhibitors. (See Table 4
in the ARISTADA full Prescribing Information)
Commonly Observed Adverse Reactions: In pharmacokinetic
studies the safety profile of ARISTADA INITIO was generally
consistent with that observed for ARISTADA. The most common
adverse reaction (≥5% incidence and at least twice the rate of
placebo reported by patients treated with ARISTADA 441mg and 882 mg
monthly) was akathisia.
Injection-Site Reactions: In pharmacokinetic studies
evaluating ARISTADA INITIO, the incidences of injection site
reactions with ARISTADA INITIO were similar to the incidence
observed with ARISTADA. Injection-site reactions were
reported by 4%, 5%, and 2% of patients treated with 441 mg ARISTADA
(monthly), 882 mg ARISTADA (monthly), 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 INITIO and/or 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 INITIO and/or ARISTADA and any potential adverse effects
on the infant from ARISTADA INITIO and/or ARISTADA or from the
underlying maternal condition.
Please see full Prescribing Information, including Boxed Warning
for ARISTADA INITIO and ARISTADA.
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, multiple sclerosis and
oncology. 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 future
development plans; the potential therapeutic value of the company's
approved products and investigational product candidates; and the
company's plans for presentation of results from studies of its
approved products and investigational product candidates. 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 those risks
described in the Alkermes plc Annual Report on Form 10-K for the
year ended Dec. 31, 2018, and in
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.
ARISTADA® and ARISTADA INITIO® are
registered trademarks of Alkermes Pharma Ireland Limited.
INVEGA SUSTENNA® is a registered trademark of Johnson
& Johnson.
Alkermes Contacts:
For Investors: Sandy Coombs, +1 781 609 6377
For Media: Marisa Borgasano, +1 781
609 6659
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