–– Potential New Offering Would Expand Range of
ARISTADA Doses to Three Interval Options: Once Monthly, Once Every
Six Weeks and Once Every Two Months ––
–– Notice of Allowance Issued for ARISTADA
Patent Application, Extending Expected Protection Into 2035 ––
Alkermes plc (NASDAQ: ALKS) today announced that it has
submitted a supplemental New Drug Application (sNDA) to the U.S.
Food and Drug Administration (FDA) for a two-month dosing interval
of ARISTADA® (aripiprazole lauroxil) extended-release injectable
suspension for the treatment of schizophrenia. This potential new
two-month offering would expand the range of ARISTADA dosing
intervals to include a third option for patients with
schizophrenia. ARISTADA was approved by the FDA in October 2015 as
the first long-acting atypical antipsychotic with once-monthly and
once-every-six-weeks dosing options.
Alkermes also announced that the United States Patent and
Trademark Office (USPTO) has issued a Notice of Allowance for U.S.
Patent Application 14/663,042 related to ARISTADA, with allowed
claims that will cover methods of treatment for schizophrenia.
Alkermes expects this patent to issue within the next few months
and expire no earlier than March 2035. A Notice of Allowance is
issued after the USPTO makes a determination that a patent can be
granted from an application.
“We are designing ARISTADA to offer unprecedented flexibility in
terms of doses and dosing intervals because, as long-acting
injectable antipsychotics continue to grow in the marketplace, it
becomes more evident that patients with schizophrenia and their
healthcare providers require a range of options to meet their
individualized needs,” said Elliot Ehrich, M.D., Chief Medical
Officer of Alkermes. “This step toward expanding the ARISTADA
product offering adds to Alkermes’ growing suite of products to
address the real-world needs of patients with schizophrenia. We
look forward to working with the FDA to offer this important, new
two-month dosing option of ARISTADA to patients and physicians as
quickly as possible.”
The sNDA for ARISTADA is based on the positive results from a
recent randomized, open-label trial that assessed the
pharmacokinetics (PK), safety and tolerability of ARISTADA when
administered at the investigational two-month interval and at the
FDA-approved dosing intervals of once monthly and once every six
weeks. A total of 140 patients with stable schizophrenia were
randomized to receive either 441 mg ARISTADA once per month, 882 mg
ARISTADA every six weeks or 1064 mg ARISTADA every two months.
Results from the study showed that the 1064 mg dose of ARISTADA
achieved therapeutically relevant plasma concentrations of
aripiprazole with a PK profile that supports dosing once every two
months. The most common adverse event for the two-month dosing
interval was injection site pain.
About
SchizophreniaSchizophrenia 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 2.8 million American adults
have schizophrenia,1, 2 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. ARISTADA was approved by the FDA in October 2015.
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.
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.
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: decisions by the FDA
relating to the sNDA submission for the two-month dosing option of
ARISTADA; the therapeutic value, development plans and commercial
potential of the two-month dosing option of ARISTADA; whether
Patent Application 14/663,042 will issue; if such Patent
Application is issued, whether the issued patent will adequately
protect ARISTADA; and the expiration date and strength of the
method of treatment claims of such issued patent. 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: adverse
decisions by regulatory authorities; the two-month dosing option of
ARISTADA could be ineffective or unsafe; the company may be unable
to commercially manufacture the two-month dosing option of ARISTADA
successfully; the validity or enforceability of Patent Application
14/663,042, if issued, may be challenged by one or more third
parties and upheld; and those risks described in the Alkermes plc
Annual Report on Form 10-K for the fiscal year ended Dec. 31, 2015,
and in 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 registered trademark of Alkermes Pharma Ireland
Limited.
1 U.S. Census.2 National Institute of Mental
Health. Schizophrenia. Accessed on Aug. 5, 2016 from
http://www.nimh.nih.gov/health/statistics/prevalence/schizophrenia.shtml.
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Alkermes Contacts:For Investors:Eva
Stroynowski, +1 781-609-6823orSandy Coombs, +1 781-609-6377orFor
Media:Jennifer Snyder, +1 781-609-6166
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