— Initiation With Aripiprazole Lauroxil
NanoCrystal Dispersion® Designed to Replace Need for Concomitant
Three Weeks of Oral Aripiprazole With First ARISTADA Dose —
— FDA Action Expected by June 30, 2018
—
Alkermes plc (NASDAQ: ALKS) today announced that the New Drug
Application (NDA) for Aripiprazole Lauroxil NanoCrystal®
Dispersion (ALNCD), a novel, investigational product designed for
initiation onto ARISTADA® (aripiprazole lauroxil) extended-release
injectable suspension for the treatment of schizophrenia, has been
accepted for filing by the U.S. Food and Drug Administration (FDA).
The FDA has issued a target action date for the ALNCD NDA of June
30, 2018 under the Prescription Drug User Fee Act (PDUFA).
“The acceptance of this filing marks a significant milestone as
we seek approval for Aripiprazole Lauroxil NanoCrystal Dispersion
as a novel product designed for initiation onto ARISTADA for the
treatment of schizophrenia,” said Elliot Ehrich, M.D., Executive
Vice President, Research and Development of Alkermes. “We look
forward to working with the Agency in the coming months with the
goal of bringing this potential new initiation product for ARISTADA
to healthcare providers and their patients as quickly as
possible.”
If approved, administration of ALNCD in conjunction with a
single oral dose of 30 mg aripiprazole will replace the need for
three weeks of concomitant oral aripiprazole with the first dose of
ARISTADA. The ALNCD investigational product is designed for
initiation onto any dose or duration of ARISTADA (441 mg, 662 mg or
882 mg monthly, 882 mg once every six weeks, and 1064 mg once every
two months).
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,1 with men
and women affected equally.
About ARISTADA®
ARISTADA is an injectable atypical antipsychotic approved 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. Oral aripiprazole should be
administered for 21 consecutive days in conjunction with the first
injection of ARISTADA. A New Drug Application (NDA) for
Aripiprazole Lauroxil NanoCrystal® Dispersion (ALNCD), an
investigational product designed for initiation onto ARISTADA, is
under review by the U.S. Food and Drug Administration (FDA). If
approved, administration of ALNCD in conjunction with a single oral
dose of 30 mg aripiprazole will provide an alternative to the three
weeks of concomitant oral aripiprazole with the first dose of
ARISTADA.
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. 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 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 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 akathisia.
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 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 company’s
expectations and timeline for regulatory action by
the FDA relating to the NDA submission for ALNCD for the
treatment of schizophrenia; approval by the FDA of the NDA for
ALNCD; and the potential therapeutic and commercial value of ALNCD
and 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: whether the
NDA for ALNCD will be approved by the FDA by June 30, 2018 or
at all; if approved, whether ALNCD will be commercialized
successfully; whether ARISTADA or ALNCD could be shown ineffective
or unsafe; 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 Sept. 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® and NanoCrystal® are registered trademarks of Alkermes
Pharma Ireland Limited.
1National Institutes of Health. Schizophrenia. Accessed November
15, 2017 from
https://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=67.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171116005137/en/
Alkermes Contacts:For Investors:Eva
Stroynowski, +1 781-609-6823orSandy Coombs, +1 781-609-6377orFor
Media:Lindsey Smith, +1 781-609-6231
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