DUBLIN, Sept. 14, 2020 /PRNewswire/ -- Alkermes
plc (Nasdaq: ALKS) today announced the presentation of new
real-world outcomes research and clinical data related to its
psychiatry portfolio at the Psych Congress 2020 Virtual
Experience, held Sept. 10-13, 2020.
The company presented six posters, one of which focused on new
outcomes research that analyzed treatment challenges of
second-generation antipsychotics, such as weight gain and treatment
interruptions, in patients living with schizophrenia or bipolar I
disorder.
The recent outcomes research used data from the OM1 Real-World
Data Cloud1 to assess patterns of
antipsychotic-associated weight gain and treatment interruptions
(i.e., switching or discontinuation) among patients with
schizophrenia or bipolar I disorder who initiated oral
second-generation antipsychotics of moderate-to-high weight gain
risk.2 A total of 8,174 patients with schizophrenia and
9,142 patients with bipolar I disorder were included in this
retrospective analysis, with an average age of 57 years and 48
years, respectively.
"Real-world data is important in understanding the impact that
certain treatment side effects may have on a patient," said
Linda Stalters, MSN, APRN(ret),
Founder and Director of Health Affairs at Schizophrenia and Related
Disorders Alliance of America (SARDAA). "Schizophrenia and bipolar
I disorder are lifelong diseases that may require long-term
treatment, so it is important to take a holistic approach when
considering a patient's treatment journey."
"We were pleased to share new research at this year's virtual
Psych Congress, underscoring Alkermes' commitment to addressing the
challenges faced by those living with serious mental illness,"
said Amy O'Sullivan, Vice President, Health Economics and
Outcomes Research at Alkermes. "The outcomes research findings
offer insight into the weight gain and treatment interruption
patterns that may occur in patients with schizophrenia and bipolar
I disorder, providing us with a broader understanding of the
potential needs of these patient communities."
In addition to the outcomes data, Alkermes presented several
posters related to the company's psychiatry products and
development candidates,
ARISTADA® (aripiprazole lauroxil), ARISTADA
INITIO® (aripiprazole lauroxil) and ALKS
3831 (olanzapine/samidorphan). The full list of Alkermes'
presentations at Psych Congress is as follows:
- Poster #101: "A Combination of Olanzapine and Samidorphan in
Adults With Schizophrenia and Bipolar I Disorder: Overview of
Clinical Data"
- Poster #135: "Disease Prevalence, Comorbid Conditions, and
Medication Utilization Among Patients with Schizophrenia in
the United States"
- Poster #185: "Phase 3 Safety and Tolerability Results of the
Combination of Olanzapine and Samidorphan in Patients With
Schizophrenia: The 1-Year ENLIGHTEN-2-Extension"
- Poster #192: "Qualitative Clinical Trial Exit Interviews
Evaluating Treatment Benefit, Burden, and Satisfaction in Patients
With Schizophrenia"
- Poster #200: "Safety and Tolerability of Aripiprazole Lauroxil
2-Month Formulation With 1-Day Initiation for Treatment of
Schizophrenia in the ALPINE Study"
- Poster #214: "Weight Gain and Treatment Interruptions with
Second-Generation Oral Antipsychotics: Analysis of Real-World Data
Among Patients with Schizophrenia or Bipolar I Disorder"
For more information, please visit the Psych
Congress website at https://national.psychcongress.com.
About ALKS 3831
ALKS 3831 is an investigational,
novel, once-daily, oral atypical antipsychotic drug candidate for
the treatment of adults with schizophrenia and for the treatment of
adults with bipolar I disorder. 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 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 the
ARISTADA INITIO regimen or up to 10 days thereafter.
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
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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.
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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.
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About Alkermes
Alkermes plc is a fully
integrated, global biopharmaceutical company developing innovative
medicines in the fields of neuroscience and oncology. The company
has a portfolio of proprietary commercial products focused on
addiction and schizophrenia, and a pipeline of product candidates
in development for schizophrenia, bipolar I disorder,
neurodegenerative disorders and cancer. 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.
ARISTADA® and ARISTADA
INITIO® are registered trademarks of Alkermes
Pharma Ireland Limited.
1 The OM1 Real-World Data Cloud (OM1, Inc.;
Boston, MA) includes de-identified
patient-level health care claims and electronic medical records
(EMRs) linked for >50 million patients using a proprietary
method with patient-specific identifiers.
2 Oral second-generation antipsychotics of
moderate-to-high weight gain risk included in the retrospective
analysis were: Olanzapine, Clozapine (SZ only), Iloperidone (SZ
only), Paliperidone (SZ only), Risperidone, Quetiapine,
Olanzapine/fluoxetine combination (BD-1 only)
Alkermes Contacts:
For Investors: Sandy Coombs, +1 781 609 6377
For Media: Marisa Borgasano, +1 781
609 6659
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SOURCE Alkermes plc