— Data Presented at 30th Annual Psych
DUBLIN--(BUSINESS WIRE)--Sep. 18, 2017--
plc (NASDAQ: ALKS) today announced positive topline results from a
phase 4 clinical study of ARISTADA® (aripiprazole
lauroxil) extended-release injectable suspension for the treatment of
schizophrenia. Data from the open-label prospective study showed that
switching to treatment with ARISTADA led to statistically significant
and clinically meaningful improvement in schizophrenia symptoms at the
end of the six-month study in patients who had experienced inadequate
response or intolerance to INVEGA SUSTENNA® (paliperidone
palmitate). Results from the study were presented at the 30th
Annual Psych Congress (Psych Congress) in New Orleans.
“These data further add to the substantial body of evidence supporting
the differentiated efficacy and safety profile of ARISTADA in the
treatment of this chronic and debilitating disease,” said Elliot Ehrich,
M.D., Executive Vice President, Research and Development of Alkermes.
“Driven by scientific and economic outcomes data, the recognition of the
benefits of long-acting atypical antipsychotics continues to grow within
the medical community. Alkermes remains committed to innovating in this
disease area where there remains significant unmet medical need and
“The results from this study highlight the potential clinical benefits
of switching to ARISTADA for patients who experience inadequate response
or intolerance to INVEGA SUSTENNA, a medicine widely recognized in the
clinical community as a powerful antipsychotic agent,” stated Steven
Potkin, M.D., Professor Emeritus of Psychiatry and Human Behavior at the
University of California, Irvine. “Patients and their healthcare
providers need options with different pharmacology when choosing a
treatment regimen, and these data further support the use of ARISTADA in
the treatment of schizophrenia.”
Data from the phase 4 study showed that treatment with a flexible dose
regimen of ARISTADA 441 mg, 662 mg or 882 mg monthly, or 882 mg every
six weeks resulted in significant improvement in schizophrenia symptoms
at six months, as measured by the Brief Psychiatric Rating Scale (BPRS)
and the Clinical Global Impressions-Severity (CGI-S) scale. The mean
BPRS total score decreased from 37.6 to 32.7 (p=0.002), and the mean
CGI-S score decreased from 3.9 to 3.4 (p<0.001) between baseline and the
six-month endpoint. Thirty-four patients (68%) completed the six-month
study. The most commonly reported adverse events in the study were
psychotic disorders, anxiety and suicidal ideation.
“These important data underscore the unique attributes of ARISTADA in
the market. With a strong efficacy and safety profile, along with an
unmatched range of doses and durations, ARISTADA has the potential to
become a market leader in the growing long-acting atypical antipsychotic
class,” said Richard Pops, Chief Executive Officer of Alkermes. “We
continue to make progress with the ARISTADA launch and look forward to
helping patients living with schizophrenia manage their disease with
A poster on the data, titled, “Switching Patients With Schizophrenia
From Paliperidone Palmitate to Aripiprazole Lauroxil: A 6-month
Prospective Open-Label Study,” was presented at Psych Congress on Sept.
17 and 18, 2017. For more information, please visit the Psych Congress
website at http://www.psychcongress.com/psychcongress/.
open-label, single-arm phase 4 study was designed to assess the
efficacy, safety and tolerability of ARISTADA (441 mg, 662 mg, or 882 mg
monthly; or 882 mg every six weeks) in 50 symptomatic, clinically stable
patients with schizophrenia who had an inadequate response or
intolerance to INVEGA SUSTENNA. Efficacy was evaluated in the study
based on BPRS and CGI-S scores from commencement of treatment with
ARISTADA through the end of the treatment period. Safety and
tolerability were evaluated based on reported adverse events.
Patients enrolled in the study had received at least three consecutive
doses of INVEGA SUSTENNA prior to screening, with nearly half of the
patients entering the study having received the highest dose of INVEGA
SUSTENNA 234 mg. The primary reason for discontinuation of INVEGA
SUSTENNA was insufficient control of positive symptoms (n=33, 66%).
Eight patients (16%) switched due to breakthrough negative symptoms, and
nine patients (18%) switched due to intolerance to INVEGA SUSTENNA.
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 2.4 million American adults
have schizophrenia,1 with men and women affected equally.
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 DEMENTIA-
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
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 potential therapeutic and
commercial value of ARISTADA for the treatment of schizophrenia. 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 whether results of ARISTADA’s development
activities are predictive of real-world results and those 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 & Johnson.
1National Institutes of Health. Schizophrenia.
Accessed on Sept. 15, 2017 from https://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=67.
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Source: Alkermes plc
Eva Stroynowski, +1 781-609-6823
Coombs, +1 781-609-6377
Lindsey Smith, +1