DUBLIN, May 22, 2015 /PRNewswire/ -- Actavis plc
(NYSE: ACT) today confirmed that a panel of the U.S. Court of
Appeals for the Second Circuit has issued a ruling upholding a
December 15, 2014 preliminary
injunction requiring the Company to continue distribution of
NAMENDA® (memantine HCl) immediate-release tablets.
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"While we are disappointed by the Court's decision to uphold
this ruling, we intend to continue our strong efforts to convey the
significant benefits of NAMENDA XR® to physicians, patients and
caregivers," said Brent Saunders,
CEO and President of Actavis. "Patient demand for NAMENDA XR®
is currently trending at more than 50 percent of the total product
line's days of therapy and growing, underscoring the strong
physician, patient and caregiver demand for our once-daily
product."
"We have also recently launched once-daily NAMZARIC®, a
fixed-dose combination of NAMENDA XR® and donepezil that provides
another treatment option for patients with moderate to severe
Alzheimer's disease. Since the launch of NAMENDA XR® in 2013,
the two medications, NAMENDA XR® and donepezil, have been commonly
prescribed in combination with one another to treat the symptoms of
moderate to severe Alzheimer's disease. NAMZARIC® offers an option
with the benefits of both treatments, while reducing the number of
pills a patient and their caregivers need to administer each day,
to treat this disease."
Actavis noted that the Company will continue to manage sales and
R&D expenses to ensure that the Appeals court's decision will
have minimal to no impact on its 2015 NAMENDA® franchise
contribution to earnings and longer term company earnings
aspirations.
About NAMENDA XR®
NAMENDA XR® (memantine HCl) extended release capsules are a
higher dose, once-daily formulation of NAMENDA® immediate release
indicated for the treatment of moderate to severe dementia of the
Alzheimer's type. Its mechanism of action focuses on the glutamate
pathway, a target for the treatment of Alzheimer's disease. The
efficacy and safety of NAMENDA XR® was established in a 24 week,
randomized, double-blind, placebo-controlled trial of 677
outpatients on a stable dose of acetylcholinesterase inhibitors
(AChEl).
NAMENDA XR® 28 mg plus an AChEI demonstrated statistically
significant improvement in cognition and global function compared
to placebo plus an AChEI. Cognition was measured by the Severe
Impairment Battery Scale (2.6 unit mean difference). Global
function was measured by the Clinician's Interview-Based Impression
of Change Scale (0.3. unit mean difference).
There is no evidence that NAMENDA XR® or an AChEI prevents or
slows the underlying disease process in patients with Alzheimer's
disease.
Dosing and Administration
- The recommended starting dose of NAMENDA XR® is 7 mg once
daily. The recommended target dose is 28 mg once daily. The dose
should be increased in 7 mg increments to 28 mg once daily. The
minimum recommended interval between dose increases is one week and
only if the previous dose has been well tolerated. The maximum
recommended dose is 28 mg once daily.
- It is recommended that a patient who is on a regimen of 10 mg
twice daily of NAMENDA tablets be switched to NAMENDA XR® 28 mg
once-daily capsules the day following the last dose of a 10 mg
NAMENDA® tablet. There is no study addressing the comparative
efficacy of these 2 regimens.
- It is recommended that a patient with severe renal impairment
who is on a regimen of 5 mg twice daily of NAMENDA® tablets be
switched to NAMENDA XR 14 mg once-daily capsules the day following
the last dose of a 5 mg NAMENDA® tablet.
Special Populations
- NAMENDA XR® should be administered with caution to patients
with severe hepatic impairment.
- A target dose of 14 mg/day is recommended in patients with
severe renal impairment (creatinine clearance of 5-29 mL/min, based
on the Cockcroft-Gault equation).
IMPORTANT SAFETY INFORMATION
Contraindications
- NAMENDA XR is contraindicated in patients with known
hypersensitivity to memantine hydrochloride or to any excipients
used in the formulation.
Warnings and Precautions
- NAMENDA XR should be used with caution under conditions that
raise urine pH (including alterations by diet, drugs and the
clinical state of the patient). Alkaline urine conditions may
decrease the urinary elimination of memantine, resulting in
increased plasma levels and a possible increase in adverse
effects.
- NAMENDA XR has not been systematically evaluated in patients
with a seizure disorder.
Adverse Reactions
- The most commonly observed adverse reactions seen in patients
administered NAMENDA XR (28 mg/day) in a controlled clinical trial,
defined as those occurring at a frequency of at least 5% in the
NAMENDA XR group and at a higher frequency than placebo were
headache (6% vs 5%), diarrhea (5% vs 4%), and dizziness (5% vs
1%).
Drug Interactions
- No drug-drug interaction studies have been conducted with
NAMENDA XR, specifically. The combined use of NAMENDA XR with other
NMDA antagonists (amantadine, ketamine, or dextromethorphan) has
not been systematically evaluated and such use should be approached
with caution.
Please visit www.NamendaXR.com for more information and full
prescribing information.
About NAMZARIC™
NAMZARIC is a once-daily, fixed-dose combination of memantine
hydrochloride extended-release, a NMDA receptor antagonist, and
donepezil hydrochloride, an acetylcholinesterase inhibitor.
NAMZARIC will be available in two dosage strengths, 28/10 mg
(memantine HCl extended-release/donepezil HCl) and 14/10mg
(memantine HCl extended-release/donepezil HCl) for patients with
severe renal impairment. Memantine hydrochloride extended-release
is the active ingredient in the currently marketed NAMENDA XR®,
which is indicated for the treatment of moderate to severe dementia
of the Alzheimer's type. Donepezil is the active ingredient in
ARICEPT® (donepezil hydrochloride), which is indicated for the
treatment of mild to severe dementia of the Alzheimer's type.
Actavis and Adamas collaborated on the development of the
fixed-dose combination and Actavis will have exclusive U.S.
commercialization rights, while Adamas will retain exclusive
commercialization rights outside of the U.S.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
NAMZARIC is contraindicated in patients with known
hypersensitivity to memantine hydrochloride, donepezil
hydrochloride, piperidine derivatives, or to any excipients used in
the formulation.
WARNINGS AND PRECAUTIONS
- Anesthesia: NAMZARIC is likely to exaggerate
succinylcholine-type muscle relaxation during anesthesia.
- Cardiovascular Conditions: NAMZARIC may have vagotonic effects
on the sinoatrial and atrioventricular nodes manifesting as
bradycardia or heart block. Bradycardia or heart block may manifest
in patients both with and without known underlying cardiac
conduction abnormalities.
- Peptic Ulcer Disease and Gastrointestinal Bleeding: Patients
treated with NAMZARIC should be monitored closely for symptoms of
active or occult gastrointestinal bleeding, especially those at
increased risk for developing ulcers, those with a history of ulcer
disease, or those receiving concurrent nonsteroidal
anti-inflammatory drugs (NSAIDs).
- Nausea and Vomiting: NAMZARIC can cause diarrhea, nausea, and
vomiting, although in most cases these effects have been mild and
transient, and have resolved during continued treatment.
- Genitourinary Conditions: NAMZARIC may cause bladder outflow
obstructions. Conditions that raise urine pH may decrease the
urinary elimination of memantine resulting in increased plasma
levels of memantine.
- Seizures: Cholinomimetics, including donepezil hydrochloride,
are believed to have some potential to cause generalized
convulsions. However, seizure activity also may be a manifestation
of Alzheimer's disease.
- Pulmonary Conditions: Cholinesterase inhibitors should be
prescribed with care to patients with a history of asthma or
obstructive pulmonary disease.
ADVERSE REACTIONS
- The most common adverse reactions, occurring at a frequency of
at least 5% in patients taking memantine hydrochloride extended
release 28 mg/day, and greater than placebo, were headache (6% vs
5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%).
- The most common adverse reactions, occurring at a frequency of
at least 5% in patients taking donepezil, and at twice or more the
rate of placebo, include diarrhea (10% vs 4%), anorexia (8% vs 4%),
vomiting (8% vs 4%), nausea (6% vs 2%), and ecchymosis (5% vs
2%).
DRUG INTERACTIONS
- Alterations of urine pH toward the alkaline condition may lead
to an accumulation of memantine with a possible increase in adverse
reactions. NAMZARIC should be used with caution under conditions
that may be associated with increased urine pH including
alterations by diet and the clinical state of the patient.
- The combined use of memantine hydrochloride with other NMDA
antagonists (amantadine, ketamine, and dextromethorphan) has not
been systematically evaluated and such use should be approached
with caution.
- Inhibitors of CYP450, 3A4 (e.g.,
ketoconazole) and 2D6 (e.g., quinidine), inhibit donepezil
metabolism in vitro. Whether there is a clinical effect of
quinidine is not known.
- Inducers of CYP3A4 (e.g., phenytoin, carbamazepine,
dexamethasone, rifampin, and phenobarbital) could increase the rate
of elimination of donepezil.
- Cholinesterase inhibitors, including donepezil hydrochloride,
have the potential to interfere with the activity of
anticholinergic medications.
DOSAGE AND ADMINISTRATION
- Patients stabilized on memantine hydrochloride (10 mg twice
daily or 28 mg extended-release once daily and donepezil
hydrochloride 10 mg) can be switched to NAMZARIC 28 mg/10 mg, taken
once a day in the evening. Patients should start NAMZARIC the day
following the last dose of memantine hydrochloride and donepezil
hydrochloride administered separately.
- Patients with severe renal impairment (creatinine clearance
5-29 mL/min, based on the Cockcroft-Gault equation), stabilized on
memantine hydrochloride (5 mg twice daily or 14 mg extended-release
once daily) and donepezil hydrochloride 10 mg, can be switched to
NAMZARIC 14 mg/10 mg, taken once daily.
About Actavis
Actavis plc (NYSE: ACT), headquartered
in Dublin, Ireland, is a unique,
global pharmaceutical company and a leader in a new industry model
– Growth Pharma. Actavis is focused on developing,
manufacturing and commercializing innovative branded
pharmaceuticals, high-quality generic and over-the-counter
medicines and biologic products for patients around the
world.
Actavis markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Actavis is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
With commercial operations in approximately 100 countries,
Actavis is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives.
Actavis intends to adopt a new global name – Allergan – pending
shareholder approval in 2015.
For more information, visit Actavis' website at
www.actavis.com.
Forward-Looking Statement
Statements contained in
this press release that refer to future events or other
non-historical facts are forward-looking statements that reflect
Actavis' current perspective of existing trends and information as
of the date of this release. Except as expressly required by law,
Actavis disclaims any intent or obligation to update these
forward-looking statements. Actual results may differ materially
from Actavis' current expectations depending upon a number of
factors affecting Actavis' business. These factors include, among
others, the difficulty of predicting the timing or outcome of FDA
approvals or actions, if any; the impact of competitive products
and pricing; market acceptance of and continued demand for Actavis'
products; risks associated with acquisitions, mergers and joint
ventures; difficulties or delays in manufacturing; and other risks
and uncertainties detailed in Actavis' periodic public filings with
the Securities and Exchange Commission, including but not limited
to Actavis' Quarterly Report on Form 10-Q for the quarter ended
March 31, 2015. Except as expressly
required by law, Actavis disclaims any intent or obligation to
update these forward-looking statements.
Actavis
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
David Belian
(862) 261-8141
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SOURCE Actavis plc