Forest Laboratories, Inc. to Present Data about Levomilnacipran & Vilazodone at the American Psychiatric Association 167th An...
May 02 2014 - 4:05PM
Business Wire
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
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