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Forest Laboratories, Inc. (NYSE:FRX) today announced it will be
presenting data from its Major Depressive Disorder (MDD) portfolio,
levomilnacipran and vilazodone, at the American Psychiatric Association
(APA) 167th annual meeting (May 3-7, 2014 in New York, N.Y.).
The levomilnacipran results will be announced in four poster
presentations:
May 5th, 2:30-4:00 PM EDT:
-
Clinical Relevance of Levomilnacipran ER Treatment in Patients With
Major Depressive Disorder: Improvements in Functional Impairment
Categories (poster #NR6-091), authored by Andrew Cutler, MD
-
The Efficacy of Levomilnacipran ER Across Symptoms of Major
Depressive Disorder: Pooled Analyses of MADRS items and Residual
Symptoms (poster #NR6-104), authored by William M. Greenberg, MD
-
Treating Major Depressive Disorder With Levomilnacipran ER:
Efficacy and Tolerability Across the Dose Range (poster #NR6-087),
authored by Gregory M. Asnis, MD
-
The Efficacy of Levomilnacipran ER in the Treatment of Patients
With Depression-Associated Fatigue Symptoms (poster #NR6-100),
authored by Marlene Freeman, MD
The vilazodone results will be announced in six poster presentations:
May 5th, 2:30 - 4:00 PM EDT:
-
Efficacy and Safety of Vilazodone 20 mg and 40 mg in Major
Depressive Disorder: A Randomized, Double-Blind, Placebo- and
Active-Controlled Trial (poster #NR6-103), authored by Carl
Gommoll, MD
-
An Evaluation of Sexual Dysfunction During Treatment of Major
Depressive Disorder with Vilazodone 20 mg and 40 mg, Citalopram, or
Placebo: Results From a Phase III Clinical Trial (poster
#NR6-113), authored by Maju Mathews, MD
-
The Efficacy of Vilazodone in Achieving Remission in Patients With
Major Depressive Disorder: Post Hoc Analyses of a Phase IV Trial (poster
#NR6-090), authored by Leslie Citrome, MD
-
Early Improvement with Vilazodone in Adults with Major Depressive
Disorder: Post Hoc Analysis of a Randomized, Double-Blind,
Placebo-Controlled Trial (poster #NR6-120), authored by Ashwin
Patkar, MD
-
The Efficacy of Vilazodone in Improving Anxiety Symptoms in
Patients with Major Depressive Disorder: Post Hoc Analyses of a Phase
IV Trial (poster # NR6-124), authored by Angelo Sambunaris, MD
May 6, 2:30 - 4:00 PM EDT:
-
Effects of Vilazodone on Depression Symptoms: Category Shift
Analysis of MADRS Items From a Randomized, Double-Blind,
Placebo-Controlled Trial (poster # NR8-057), authored by Michael
E. Thase, MD
About levomilnacipran ER capsules
FETZIMA (levomilnacipran) is a serotonin norepinephrine reuptake
inhibitor (SNRI) indicated for the treatment of Major Depressive
Disorder (MDD) in adults. The recommended therapeutic dose range for
FETZIMA is 40 mg to 120 mg once daily with or without food. The exact
mechanism of the antidepressant action (MOA) is unknown, but is thought
to be related to the potentiation of serotonin and norepinephrine in the
central nervous system, through inhibition of reuptake at serotonin and
norepinephrine transporters. Non-clinical studies have shown that
FETZIMA is a potent and selective SNRI. FETZIMA potently inhibits
serotonin (5-HT) and norepinephrine reuptake (IC50=16-19 nM
and 11 nM, respectively). Greater reuptake inhibition of norepinephrine
over serotonin was shown in vitro.
Levomilnacipran was licensed to Forest Laboratories Inc. by Pierre
Fabre, in the U.S. and Canada. Pierre-Fabre is also the active
pharmaceutical ingredient (API) supplier.
Visit FETZIMA.com for more information on this once-daily option for the
treatment of MDD in adults.
About vilazodone HCl
VIIBRYD (vilazodone) is the first and only selective serotonin reuptake
inhibitor (SSRI) and 5-HT1A receptor partial agonist for the treatment
of adults with MDD. While the mechanism of action is not fully
understood, it is thought to be related to enhancement of serotonergic
activity in the central nervous system (CNS) through selective
inhibition of serotonin reuptake. The role of 5-HT1A partial agonist
activity on serotonergic transmission and antidepressant effect is
unknown. VIIBRYD offers consistent efficacy and has an established
safety profile with reported rates of sexual dysfunction of less than 5%
and no effect on weight gain in pivotal trials. The recommended dose is
40 mg. VIIBRYD was approved in 2011 and is available in pharmacies
across the U.S.
Visit VIIBRYD.com for more information on this once-daily option for the
treatment of MDD in adults.
IMPORTANT SAFETY INFORMATION
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in children, adolescents, and young adults in short-term studies. These
studies did not show an increase in the risk of suicidal thoughts and
behavior with antidepressant use in patients over age 24; there was a
reduction in risk with antidepressant use in patients aged 65 and older.
In patients of all ages who are started on antidepressant therapy,
monitor closely for worsening, and for emergence of suicidal thoughts
and behaviors. Advise families and caregivers of the need for
close observation and communication with the prescriber.
VIIBRYD and FETZIMA are not approved for use in pediatric patients.
VIIBRYD Contraindications
-
Serotonin Syndrome and MAOIs: Do not use MAOIs intended to
treat psychiatric disorders with VIIBRYD or within 14 days of stopping
treatment with VIIBRYD. Do not use VIIBRYD within 14 days of stopping
an MAOI intended to treat psychiatric disorders. In addition, do not
start VIIBRYD in a patient who is being treated with linezolid or
intravenous methylene blue.
VIIBRYD Warnings and Precautions
-
All patients treated with antidepressants should be monitored
appropriately and observed closely for clinical worsening,
suicidality, and unusual changes in behavior, especially during the
first few months of treatment and when changing the dose. Consider
changing the therapeutic regimen, including possibly discontinuing the
medication, in patients whose depression is persistently worse or
includes symptoms of anxiety, agitation, panic attacks, insomnia,
irritability, hostility, aggressiveness, impulsivity, akathisia,
hypomania, mania, or suicidality that are severe, abrupt in onset, or
were not part of the patient's presenting symptoms. Families and
caregivers of patients being treated with antidepressants should be
alerted about the need to monitor patients daily. Prescriptions
for VIIBRYD should be written for the smallest quantity of tablets
consistent with good patient management, in order to reduce the risk
of overdose.
-
Serotonin Syndrome: The development of a potentially
life-threatening serotonin syndrome has been reported with SNRIs and
SSRIs, including VIIBRYD, both when taken alone, but especially when
co-administered with other serotonergic agents (including triptans,
tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan,
buspirone, and St. John’s Wort) and with drugs that impair metabolism
of serotonin (in particular, MAOIs, both those intended to treat
psychiatric disorders and also others, such as linezolid and
intravenous methylene blue). Symptoms of serotonin syndrome were noted
in 0.1% of VIIBRYD-treated patients in premarketing clinical trials.
Serotonin syndrome symptoms may include mental status changes (eg,
agitation, hallucinations, delirium, and coma), autonomic instability
(eg, tachycardia, labile blood pressure, diaphoresis, flushing,
hyperthermia), neuromuscular symptoms (eg, tremor, rigidity,
myoclonus, hyperreflexia, incoordination), seizures, and/or
gastrointestinal symptoms. If symptoms occur, discontinue VIIBRYD and
initiate supportive treatment. If concomitant use of VIIBRYD with
other serotonergic drugs is clinically warranted, patients should be
aware of a potential increased risk for serotonin syndrome,
particularly during treatment initiation and dose increases.
-
Like other antidepressants, VIIBRYD should be prescribed with caution
in patients with a seizure disorder.
-
The use of drugs that interfere with serotonin reuptake, including
VIIBRYD, may increase the risk of bleeding events. Patients should be
cautioned about the risk of bleeding associated with the concomitant
use of VIIBRYD and NSAIDs, aspirin, warfarin, or other drugs that
affect coagulation or bleeding.
-
Symptoms of mania/hypomania were noted in 0.1% of patients treated
with VIIBRYD in clinical studies. As with all antidepressants, VIIBRYD
should be used cautiously in patients with a history or family history
of bipolar disorder, mania, or hypomania. Prior to initiating
treatment with VIIBRYD, patients should be adequately screened to
determine if they are at risk for bipolar disorder. VIIBRYD is not
approved for use in treating bipolar depression.
-
Discontinuation symptoms, some serious, have been reported with
discontinuation of serotonergic drugs such as VIIBRYD. Gradual dose
reduction is recommended, instead of abrupt discontinuation, whenever
possible. Monitor patients when discontinuing VIIBRYD. If intolerable
symptoms occur following a dose decrease or upon discontinuation of
treatment, consider resuming the previously prescribed dose and
decreasing the dose at a more gradual rate.
-
Advise patients that if they are treated with diuretics, or are
otherwise volume depleted, or are elderly, they may be at greater risk
of developing hyponatremia while taking VIIBRYD. Although no cases of
hyponatremia resulting from VIIBRYD treatment were reported in the
clinical studies, hyponatremia has occurred as a result of treatment
with SSRIs and SNRIs. Discontinuation of VIIBRYD in patients with
symptomatic hyponatremia and appropriate medical intervention should
be instituted.
VIIBRYD Adverse Reactions
-
The most commonly observed adverse reactions in MDD patients treated
with VIIBRYD in placebo-controlled studies (incidence ≥5% and at least
twice the rate of placebo) were: diarrhea (28% vs 9%), nausea (23% vs
5%), insomnia (6% vs 2%), and vomiting (5% vs 1%).
FETZIMA Contraindications
-
FETZIMA is contraindicated in patients with a hypersensitivity to
levomilnacipran, milnacipran HCl, or to any excipient in the
formulation.
-
The use of MAOIs intended to treat psychiatric disorders with FETZIMA
or within 7 days of stopping treatment with FETZIMA is contraindicated
due to an increased risk of serotonin syndrome. The use of FETZIMA
within 14 days of stopping an MAOI intended to treat psychiatric
disorders is also contraindicated.Starting FETZIMA in a
patient who is being treated with MAOIs such as linezolid or
intravenous methylene blue is also contraindicated due to an increased
risk of serotonin syndrome.
-
Do not use FETZIMA in patients with uncontrolled narrow-angle
glaucoma. In clinical studies, FETZIMA was associated with an
increased risk of mydriasis.
FETZIMA Warnings and Precautions
-
All patients being treated with antidepressants should be monitored
appropriately and observed closely for clinical worsening,
suicidality, and unusual changes in behavior, especially during the
first few months of treatment and when increasing or decreasing the
dose. Consider changing the therapeutic regimen, including
possibly discontinuing the medication, in patients whose depression is
persistently worse or includes symptoms of anxiety, agitation, panic
attacks, insomnia, irritability, hostility, aggressiveness,
impulsivity, akathisia, hypomania, mania, or suicidality that are
severe, abrupt in onset, or were not part of the patient's presenting
symptoms. Families and caregivers of patients being treated with
antidepressants should be alerted about the need to monitor patients
daily. Prescriptions for FETZIMA should be written for the
smallest quantity of capsules consistent with good patient management,
in order to reduce the risk of overdose.
-
Serotonin Syndrome: The development of a potentially
life-threatening serotonin syndrome has been reported with SNRIs and
SSRIs both when taken alone, but especially when co-administered with
other serotonergic agents (including triptans, tricyclic
antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone,
and St. John’s Wort) and with drugs that impair metabolism of
serotonin (in particular, MAOIs, both those intended to treat
psychiatric disorders and also others, such as linezolid and
intravenous methylene blue). Symptoms of serotonin syndrome may
include mental status changes (eg, agitation, hallucinations,
delirium, and coma), autonomic instability (eg, tachycardia, labile
blood pressure, dizziness, diaphoresis, flushing, hyperthermia),
neuromuscular symptoms (eg, tremor, rigidity, myoclonus,
hyperreflexia, incoordination), seizures, and/or gastrointestinal
symptoms. If symptoms of serotonin syndrome occur, discontinue FETZIMA
immediately and initiate supportive treatment. If concomitant use of
FETZIMA with other serotonergic drugs is clinically warranted,
patients should be aware of a potential increased risk for serotonin
syndrome, particularly during treatment initiation and dose increases.
-
SNRIs, including FETZIMA, have been associated with increases in blood
pressure. Blood pressure should be measured prior to initiating
treatment and periodically throughout FETZIMA treatment. Pre-existing
hypertension should be controlled before initiating treatment with
FETZIMA. Use with caution in patients with pre-existing hypertension,
cardiovascular, or cerebrovascular conditions that might be
compromised by increases in blood pressure. Concomitant use of FETZIMA
with drugs that increase blood pressure and heart rate has not been
evaluated and such combinations should be used with caution. For
patients who experience a sustained increase in blood pressure,
discontinuation or other appropriate medical intervention should be
considered.
-
SNRIs, including FETZIMA, have been associated with an increase in
heart rate. Heart rate should be measured prior to initiating
treatment and periodically throughout FETZIMA treatment. Pre-existing
tachyarrhythmias and other cardiac disease should be treated before
starting therapy with FETZIMA. For patients who experience a sustained
increase in heart rate, discontinuation or other appropriate medical
intervention should be considered.
-
SSRIs and SNRIs, including FETZIMA, may increase the risk of bleeding
events, some serious. Concomitant use of aspirin, NSAIDs, warfarin,
and other anticoagulants may add to this risk.
-
Mydriasis has been reported in association with SNRIs including
FETZIMA; therefore, FETZIMA should be used with caution in patients
with controlled narrow-angle glaucoma. Patients with raised
intraocular pressure or those at risk of acute narrow-angle
(angle-closure) glaucoma should be monitored. DO NOT use FETZIMA in
patients with uncontrolled narrow-angle glaucoma.
-
FETZIMA can affect urethral resistance. In clinical studies, urinary
hesitation occurred in 4%, 5% and 6% of FETZIMA-treated patients
receiving doses of 40, 80, and 120 mg, respectively, compared to no
patients in the placebo group. Caution is advised when using FETZIMA
in patients prone to obstructive urinary disorders.
-
Symptoms of mania/hypomania were reported in 0.2% of FETZIMA-treated
patients and 0.2% of placebo-treated patients in clinical studies. As
with all antidepressants, FETZIMA should be used cautiously in
patients with a history or family history of bipolar disorder, mania
or hypomania. Prior to initiating treatment with FETZIMA, patients
should be adequately screened to determine if they are at risk for
bipolar disorder. FETZIMA is not approved for use in treating bipolar
depression.
-
FETZIMA should be prescribed with caution in patients with a seizure
disorder.
-
Discontinuation symptoms, some serious, have been reported with
discontinuation of serotonergic antidepressants such as FETZIMA.
Gradual dose reduction is recommended, instead of abrupt
discontinuation, whenever possible. Monitor patients when
discontinuing FETZIMA. If intolerable symptoms occur following a dose
decrease or upon discontinuation of treatment, consider resuming the
previously prescribed dose and decreasing the dose at a more gradual
rate.
-
Advise patients that if they are treated with diuretics or are
otherwise volume depleted, or are elderly, they may be at greater risk
of developing hyponatremia while taking FETZIMA. Although no cases of
hyponatremia resulting from FETZIMA treatment were reported in the
clinical studies, hyponatremia has occurred as a result of treatment
with SSRIs and SNRIs. FETZIMA should be discontinued in patients with
symptomatic hyponatremia and appropriate medical intervention should
be instituted.
FETZIMA Adverse Reactions
The most commonly observed adverse reactions in MDD patients treated
with FETZIMA in placebo-controlled studies (incidence ≥5% and at least
twice the rate of placebo) were: nausea, constipation, hyperhidrosis,
heart rate increased, erectile dysfunction, tachycardia, vomiting, and
palpitations.
About Forest Laboratories, Inc.
Forest Laboratories (NYSE:FRX) is a leading, fully integrated, specialty
pharmaceutical company largely focused on the United States market.
Forest markets a portfolio of branded drug products and develops new
medicines to treat patients suffering from diseases principally in five
therapeutic areas: central nervous system, cardiovascular,
gastrointestinal, respiratory, and anti-infective. Forest’s strategy of
acquiring product rights for development and commercialization through
licensing, collaborative partnerships and targeted mergers and
acquisitions allows Forest to take advantage of attractive late-stage
development and commercial opportunities, thereby managing the risks
inherent in drug development. In January 2014, Forest acquired Aptalis
Pharmaceuticals for $2.9 billion in cash in order to gain access to its
GI and Cystic Fibrosis products, including treatments for Ulcerative
Proctitis, Duodenal Ulcers, H. Pylori, Anal Fissures, and Pancreatic
Insufficiency. In February 2014, Forest and Actavis plc announced an
agreement where Forest would be acquired for about $25 billion in cash
and stock. The acquisition of Forest by Actavis is contingent upon
regulatory and shareholder approvals.
Forest is headquartered in New York, NY.
Except for the historical information contained herein, this release
contains forward‐looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a
number of risks and uncertainties, including the potential that the
presentations identified above are not given at all or at the times or
locations specified, in addition to the risk factors listed from time to
time in each of Forest's and Ironwood's Annual Reports on Form 10‐K,
Quarterly Reports on Form 10‐Q, and other SEC filings. Neither Forest
nor Ironwood undertakes any obligation to update these forward-looking
statements to reflect events or circumstances occurring after this press
release. These forward looking statements speak only as of the date of
this press release. All forward‐looking statements are qualified in
their entirety by this cautionary statement.
Forest Laboratories, Inc.Media Relations:Amanda Kaufman,
646-231-7316amanda.kaufman@frx.comorInvestor
Relations:Frank J. Murdolo, 212-224-6714media.relations@frx.com