-- Findings From Patient Surveys Underscore Need for New
Antipsychotic Treatments With Reduced Side Effects --
DUBLIN, Oct. 7, 2019 /PRNewswire/ -- Alkermes
plc (Nasdaq: ALKS) today announced the presentation of
new health economics and outcomes research at the 32nd
Annual Psych Congress (Psych Congress), which took place
Oct. 3-6, 2019 in San Diego. This research reflects the
company's continued commitment to improving care for, and
understanding the unique needs of, people living with serious
mental illness.
Alkermes presented results from two recently completed online
surveys evaluating the treatment experiences of people living with
schizophrenia (n=200) and bipolar I disorder (n=200), including
side effects associated with oral antipsychotic medications. Key
findings related to survey respondents' prior experiences with
antipsychotic medications include:
- Nearly all participants (98% for both schizophrenia and bipolar
I disorder) reported having experienced at least one or more
treatment side effect;
- For both patient populations, dislike of side effects was the
most common reason cited for non-adherence to oral antipsychotic
medications;
- Weight gain was reported as the most bothersome (combining
survey responses of "very bothersome" and "extremely bothersome")
side effect for both patient populations;
- Respondents in both patient populations reported that side
effects associated with oral antipsychotic medications had a
negative impact on their social functioning, including work, social
activities, relationships with friends and family, and romantic
relationships.
"Oral antipsychotic medications serve as a mainstay treatment
option for people living with serious mental illnesses like
schizophrenia and bipolar I disorder. However, as these survey
results demonstrate, treatment side effects are highly common and
can have significant impacts on patients' day-to-day lives," said
study investigator Dawn L. Velligan,
Ph.D., Department of Psychiatry and Co-Chief of the Division of
Schizophrenia and Related Disorders at UT Health San Antonio.
"These survey data offer valuable insights into the experiences
and concerns of people living with schizophrenia and bipolar I
disorder and underscore the need for expanded research and
development of treatment options that offer clinical efficacy with
a more tolerable side-effect profile," said study investigator,
Martha Sajatovic, M.D., Director of
the Neurological and Behavioral Outcomes Research Center at
University Hospitals Cleveland Medical Center.
The surveys also sought to capture participant preferences:
- When asked to consider trade-offs between improvements in
symptoms versus side effects for a hypothetical new oral
antipsychotic medication, 67% of the people with schizophrenia who
were surveyed selected improvement in symptoms over improvements in
side effects, highlighting a desire for highly efficacious
therapies;
- Respondents with bipolar I disorder ranked anxiety, weight gain
and "feeling like a zombie" as the top three side effects they
would most want to avoid in a potential new oral antipsychotic
medication.
"Alkermes is an established leader in developing treatments for
serious mental illness, and each year we look forward to the
scientific exchange that occurs at Psych Congress," said
Amy O'Sullivan, Ph.D., Vice
President of Health Economics and Outcomes Research at Alkermes.
"The results of the patient surveys presented at this year's
conference highlight the unmet needs of individuals living with
schizophrenia and bipolar I disorder in real-world settings. We are
excited to share this research with the clinical community and to
continue to explore ways we can all work together to improve care
and outcomes for people living with these complex diseases."
In addition to the patient survey results, Alkermes also
presented several posters highlighting clinical data and research
related to its schizophrenia portfolio, including
ARISTADA® (aripiprazole lauroxil) and ALKS 3831
(olanzapine/samidorphan). A full list of Alkermes' presentations at
Psych Congress follows:
- Poster #108: "Antipsychotic Treatment Experiences of
Individuals With Schizophrenia: Findings From an Online
Survey"
- Poster #107: "Antipsychotic Treatment Experiences of
Individuals With Bipolar I Disorder: Findings From an Online
Survey"
- Poster #123: "Olanzapine/Samidorphan for Schizophrenia: Weight
Gain and Metabolic Outcomes in Phase 3 ENLIGHTEN-2 and Subsequent
Long-Term, Open-Label Safety Study"
- Poster #216: "Insulin Sensitivity and Glucose Metabolism of
Olanzapine and a Combination of Olanzapine and Samidorphan: A Phase
1 Exploratory Study in Healthy Volunteers"
- Poster #256: "A Randomized, Double-Blind Study Evaluating
Olanzapine/Samidorphan on QT Prolongation"
- Poster #317: "A Phase 3, Multicenter Study to Assess the
Long-Term Safety, Tolerability and Efficacy of a Combination of
Olanzapine and Samidorphan in Subjects With Schizophrenia"
- Poster #311: "Randomized, Double-Blind, Active-Controlled Study
of Starting Aripiprazole Lauroxil With 1-Day Initiation in Acutely
Ill Patients With Schizophrenia"
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 schizophrenia and 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 INITIO®
ARISTADA
INITIO, in combination with a single 30 mg dose of oral
aripiprazole, is indicated for the initiation of ARISTADA when
used for the treatment of schizophrenia in adults and can be used
to initiate patients 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.
About ARISTADA®
ARISTADA is an
injectable atypical antipsychotic approved in the U.S. 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.
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 and oncology. 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 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.
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 potential
therapeutic, clinical and commercial value of the company's
investigational and commercial products; and the company's plans
for future research and development activities. 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, those risks
and uncertainties described under the heading "Risk Factors" in the
company's 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. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Except as required by law, the
company disclaims any intention or responsibility for updating or
revising any forward-looking statements contained in this press
release.
ARISTADA® and ARISTADA INITIO® are
registered trademarks of Alkermes Pharma Ireland Limited.
Alkermes
Contacts:
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For
Investors:
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Sandy Coombs, +1
781-609-6377
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For Media:
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Gretchen Murphy, +1
781-609-6419
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