— Poster Presentations to Highlight Company’s Broad Research
Commitment to Schizophrenia, Opioid Dependence and Depression —
— First Presentation of Recently Completed Phase 4 Study of Patients
Switching to ARISTADA® From INVEGA SUSTENNA®
to be Featured —
DUBLIN--(BUSINESS WIRE)--Sep. 5, 2017--
plc (NASDAQ:ALKS) today announced the presentation of 11 posters
highlighting clinical and real-world data pertaining to the company’s
schizophrenia, opioid dependence and depression portfolios at the
upcoming 30th Annual Psych Congress (Psych Congress) in New
Orleans, Sept. 16-19, 2017.
Key highlights include:
Topline results from the recently completed phase 4 study in patients
with schizophrenia who switched to ARISTADA® (aripiprazole
lauroxil) after experiencing an inadequate response or intolerance to
their INVEGA SUSTENNA® (paliperidone palmitate) regimen
Data supporting the safety and pharmacokinetic profile of two-month
Retrospective analyses comparing utilization of healthcare resources
and costs for patients prescribed long-acting injectable (LAI) versus
oral antipsychotics for schizophrenia
Real-world data analyzing the prevalence of opioid dependence and
rates of treatment in commercial populations, and the estimated impact
of increasing use of opioid use disorder (OUD) treatment on reducing
the socioeconomic burden
Patient survey data characterizing symptoms and challenges faced by
individuals with depression and their effects on overall patient
“The data being presented at Psych Congress further demonstrate our
steadfast commitment to research in central nervous system diseases as
we work to bring innovative medicines to patients with critical unmet
needs. We look forward to sharing these data with the mental health and
addiction communities at this important venue,” said Craig Hopkinson,
M.D., Chief Medical Officer and Senior Vice President of Clinical
Development and Medical Affairs at Alkermes.
A full list of Alkermes presentations at Psych Congress follows:
Poster #259: “Switching Patients With Schizophrenia From Paliperidone
Palmitate to Aripiprazole Lauroxil: A 6-month Prospective Open-Label
Study,” on Sunday, Sept. 17, 2017 and Monday, Sept. 18, 2017, 1:30 –
2:30 p.m. CT
Poster #254: “Durability of Therapeutic Response With Long-Term
Aripiprazole Lauroxil Treatment Following Successful Resolution of an
Acute Episode of Schizophrenia: A Post-hoc Analysis,” on Sunday, Sept.
17, 2017 and Monday, Sept. 18, 2017, 1:30 – 2:30 p.m. CT
Poster #261: “Safety and Pharmacokinetic Profile of a 2-Month Dose
Regimen of Aripiprazole Lauroxil: A 44-Week Phase 1 Study and
Subsequent Population Pharmacokinetic Modeling,” on Sunday, Sept. 17,
2017 and Monday, Sept. 18, 2017, 1:30 – 2:30 p.m. CT
Poster #152: “Treatment Patterns, Healthcare Resource Utilization and
Costs in Schizophrenia Patients Treated With Long-Acting Injectable vs
Oral Antipsychotics: A Real-World Study,” on Sunday, Sept. 17, 2017,
1:30 – 2:30 p.m. CT
Poster #260: “A Phase 3 Study to Evaluate Weight Gain of ALKS 3831
Compared With Olanzapine in Adults With Schizophrenia,” on Sunday,
Sept. 17, 2017 and Monday, Sept. 18, 2017, 1:30 – 2:30 p.m. CT
Poster #240: “Estimated Impact of Opioid Use Disorder Treatment on
Societal Burden,” on Sunday, Sept. 17, 2017 and Monday, Sept. 18,
2017, 1:30 – 2:30 p.m. CT
Poster #242: “Prevalence and Treatment Patterns of Opioid Use Disorder
in Two Commercial Populations,” on Sunday, Sept. 17, 2017 and Monday,
Sept. 18, 2017, 1:30 – 2:30 p.m. CT
Poster #241: “Unmet Needs in the Treatment of Substance Use Disorder,”
on Sunday, Sept. 17, 2017 and Monday, Sept. 18, 2017, 1:30 – 2:30 p.m.
Poster #124: “ALKS 5461: A Buprenorphine-Samidorphan Combination for
Major Depression,” on Sunday, Sept. 17, 2017, 1:30 – 2:30 p.m. CT
Poster #258: “Depressive Symptoms and Their Impact on Functioning and
Overall Well-Being From A Patient’s Perspective,” on Sunday, Sept. 17,
2017 and Monday, Sept. 18, 2017, 1:30 – 2:30 p.m. CT
Poster #257: “Patients’ Experience of Challenges With Symptoms and
Treatments for Depression,” on Sunday, Sept. 17, 2017 and Monday,
Sept. 18, 2017, 1:30 – 2:30 p.m. CT
All poster presentations will take place in the Exhibit Hall. For more
information, please visit the Psych Congress website at http://www.psychcongress.com/psychcongress/.
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 ALKS 5461
ALKS 5461 is a proprietary, investigational, once-daily oral medicine
that acts as a balanced neuromodulator in the brain and represents a
novel mechanism of action for the adjunctive treatment of major
depressive disorder (MDD). ALKS 5461 consists of samidorphan and
buprenorphine, and is designed to rebalance brain function that is
dysregulated in the state of depression. In October 2013, the FDA
granted Fast Track status for ALKS 5461 for the adjunctive treatment of
MDD in patients with an inadequate response to standard antidepressant
ARISTADA is an injectable atypical antipsychotic with one-month,
six-week and two-month dosing options for the treatment of
schizophrenia. Oral aripiprazole should be administered for 21
consecutive days in conjunction with the first injection of ARISTADA.
Once in the body, ARISTADA converts to aripiprazole.
INDICATION and IMPORTANT SAFETY INFORMATION for ARISTADA® (aripiprazole
lauroxil) extended-release injectable suspension, for intramuscular use
ARISTADA is indicated for the treatment of schizophrenia.
IMPORTANT SAFETY INFORMATION
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
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
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
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. 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 ARISTADA 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 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. 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
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 from 441 mg to 662 mg 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 reported
by patients treated with ARISTADA 441 mg and 882 mg monthly) was
Injection-Site Reactions: 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 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
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
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 therapeutic, clinical and
commercial value of our investigational and commercial products. 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, whether clinical results for the
company’s investigational and commercial products will be predictive of
future clinical study results or commercial success; and 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, 2016
and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2017
and June 30, 2017 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® is a registered trademark of Alkermes Pharma
INVEGA SUSTENNA® is a registered trademark of Johnson &
1National Institutes of Health. Schizophrenia.
Accessed on Sept. 1, 2017 from https://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=67.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170905005330/en/
Source: Alkermes plc
Sandy Coombs, +1-781-609-6377
Lindsey Smith, +1-781-609-6231