— First Long-Acting Atypical Antipsychotic With Both Once-Monthly and
Six-Week Dosing Options —
— Product Features Include Range of Dose Strengths and Multiple
Dosing Intervals Designed to Address Individual Patient Needs —
— Company to Host Conference Call at 7:30 a.m. EDT Tomorrow —
Company Website:
http://www.alkermes.com
DUBLIN -- (Business Wire)
Alkermes
plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug
Administration (FDA) has approved ARISTADA™ (aripiprazole lauroxil)
extended-release injectable suspension for the treatment of
schizophrenia. ARISTADA is the first atypical antipsychotic with
once-monthly and six-week dosing options for delivering and maintaining
therapeutic levels of medication in the body through an injection.
Alkermes is preparing to launch ARISTADA immediately.
This Smart News Release features multimedia. View the full release here:
http://www.businesswire.com/news/home/20151005006733/en/
“ARISTADA is a new treatment option designed to offer flexibility to
meet the real-world needs of patients suffering from schizophrenia and
the healthcare professionals providing their care,” said Elliot Ehrich,
M.D., Chief Medical Officer of Alkermes. “Building on nearly two decades
of experience developing innovative medicines for chronic and serious
CNS diseases, we are dedicated to helping to improve the lives of
patients as well as meeting the needs within the treatment ecosystem of
caregivers, physicians, payers and society. We look forward to making
ARISTADA available to patients and healthcare providers as quickly as
possible.”
ARISTADA’s features, including a range of dose strengths and dosing
interval options, are designed to address the individual needs of
patients and challenges in the treatment of schizophrenia. As a
long-acting injectable medicine, ARISTADA provides patients, clinicians
and families the certainty that patients receive medication for this
serious brain disorder. Long-acting injectable antipsychotics provide
patients with blood concentrations of active drug that remain within a
therapeutic range for an extended period of time1 and help
healthcare providers to track patient adherence.2
“Schizophrenia is a serious and debilitating disease where, despite the
existence of many medicines, there remains significant unmet medical
need and suffering. New treatment options are needed to help patients
and their families better manage this illness,” said David Henderson,
M.D., Associate Professor of Psychiatry at Massachusetts General
Hospital. “Long-acting therapies are rapidly evolving to the forefront
of the treatment of schizophrenia as clinicians increasingly recognize
the potential benefits of less frequent dosing and consider their use
earlier in disease progression.”
The FDA approval of ARISTADA was based on a proven safety and efficacy
profile, including data from a randomized, double-blind,
placebo-controlled, phase 3 study in 623 patients with schizophrenia.
Data from that trial showed that multiple dose strengths of ARISTADA met
the primary endpoint with statistically significant and clinically
meaningful reductions in Positive and Negative Syndrome Scale (PANSS)
total scores at Week 12, met the key secondary endpoint and demonstrated
significant improvements in schizophrenia symptoms versus placebo. The
most common adverse events in the study were insomnia, akathisia and
headache. The results of the phase 3 study were published in June 2015
by The Journal of Clinical Psychiatry, a peer-reviewed
medical journal.
Conference Call
Alkermes will host a conference call on Tuesday, Oct. 6, 2015, at 7:30
a.m. EDT (12:30 p.m. BST). The conference call may be accessed by
dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for
international callers. The conference call ID number is 6037988. The
conference call will also be webcast on the Investors section of
Alkermes’ website at www.alkermes.com.
In addition, a replay of the conference call will be available from 9:30
a.m. EDT (2:30 p.m. BST) on Tuesday, Oct. 6, 2015, through 5:00 p.m. EDT
(10:00 p.m. BST) on Tuesday, Oct. 13, 2015, and may be accessed by
visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S.
callers and +1 630 652 3042 for international callers. The replay access
code is 6037988.
About Schizophrenia
Schizophrenia 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,3 with men and
women affected equally. Worldwide, it is estimated that one person in
every 100 develops schizophrenia, which is one of the most serious types
of mental illness.
About ARISTADA™
ARISTADA is an injectable atypical antipsychotic with one-month and
six-week dosing options for the treatment of schizophrenia. ARISTADA is
administered by a healthcare professional. Once in the body, ARISTADA
converts to aripiprazole.
INDICATION and IMPORTANT SAFETY INFORMATION for
ARISTADA™ (aripiprazole lauroxil) extended-release injectable
suspension, for intramuscular use
INDICATION
ARISTADA is indicated for the treatment of schizophrenia.
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 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
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 is not approved for the treatment of patients with
dementia-related psychosis.
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. There is no
known treatment for established TD, although the syndrome 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.
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.
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
dehydration.
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 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 in
patients treated with ARISTADA) was akathisia.
Injection-Site Reactions: Injection-site reactions were reported
by 4%, 5%, and 2% of patients treated with 441 mg ARISTADA, 882 mg
ARISTADA, 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
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 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
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 timing of the launch of ARISTADA
in the U.S., the commercialization of ARISTADA and 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, among others: when ARISTADA will become
commercially available; whether the safety and efficacy results
demonstrated in our clinical study of ARISTADA for the treatment of
schizophrenia will be predictive of safety and efficacy results when
commercialized; whether ARISTADA will be commercialized successfully;
whether third party payers will cover or reimburse ARISTADA for the
treatment of schizophrenia; and those risks described in the Alkermes
plc Quarterly Report on Form 10-Q for the period ended June 30, 2015 and
Annual Report on Form 10-K for the fiscal year ended Dec. 31, 2014, and
in any other 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™ is a trademark of Alkermes Pharma Ireland Limited.
1Patel MX and David AS. Why aren’t depot antipsychotics
prescribed more often and what can be done about it? Adv Psychiatr
Treat, 2005; 11: 203-213.
2Kane JM et al. Guidelines
for depot antipsychotic treatment in schizophrenia. EurNeuropsychopharmacol,
1998; 8(1): 55-66.
3National Alliance on Mental Illness.
Accessed on Oct. 5, 2015 from
http://www2.nami.org/Content/NavigationMenu/Mental_Illnesses/Schizophrenia9/Home.htm.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151005006733/en/
Contacts:
Alkermes
For Investors:
Rebecca Peterson, +1 781-609-6378
or
For
Media:
Jennifer Snyder, +1 781-609-6166
Source: Alkermes plc
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