New treatment for Major Depressive Disorder is
now available to patients
Forest Laboratories, Inc. (NYSE:FRX) announced today that
FETZIMA™ (levomilnacipran ER capsules), is now available in
pharmacies throughout the United States. FETZIMA was approved by
the U.S. Food and Drug Administration (FDA) for the treatment of
Major Depressive Disorder (MDD), also known as depression, in
adults in July 2013.
“We are pleased to announce that FETZIMA is now available to
patients,” said Dr. Marco Taglietti, Executive Vice President, Drug
Development & Research and Chief Medical Officer. “Despite the
number of available antidepressant medications, the treatment of
depression remains a clinical challenge with a need for additional
treatment options. In clinical studies, patients who received
FETZIMA vs. placebo experienced meaningful improvement in their
depressive symptoms and functional impairment. The availability of
FETZIMA is a significant step forward in our goal of bringing a
range of treatment options to adults living with MDD.”
FETZIMA is a serotonin and norepinephrine reuptake inhibitor
(SNRI). The efficacy of FETZIMA was established in three positive
double-blind Phase III studies comprising two fixed-dose studies
and one flexible-dose study that compared FETZIMA to placebo in
adults with MDD. A total of more than 1,600 adult patients received
a once-daily dose of either FETZIMA (40, 80, 120 mg) or placebo in
the three studies. In all three studies, significant improvement in
depressive symptoms was demonstrated across 3 FETZIMA dosage
strengths (40, 80, and 120 mg) once daily, as measured by the
change from baseline to Week 8 in the MADRS total score. MADRS is a
widely used, physician-rated scale for assessing the severity of
depressive symptoms. Each of the 10 symptoms is rated on a scale of
0-6; higher numbers denote greater severity of symptoms.
For study 1, the mean baseline MADRS total score was 36 for all
treatment groups. The LS mean difference from placebo in change
from baseline was statistically significant at all three FETZIMA
doses (-3.2 at 40 mg/day, -4.0 at 80 mg/day, and -4.9 at 120
mg/day). For study 2, the mean baseline MADRS total score was 31
for all treatment groups. The LS mean difference from placebo in
change from baseline was statistically significant at both FETZIMA
doses studied (-3.3 at 40 mg/day, -3.1 at 80 mg/day). For study 3,
the mean baseline MADRS total score was 35 for both treatment
groups. The LS mean difference from placebo in change from baseline
was statistically significant for the FETZIMA dosing range studied
(-3.1 at 40-120 mg/day).
FETZIMA also demonstrated significant improvement in functional
impairment as measured by the mean change from baseline in the
Sheehan Disability Scale (SDS) total score. SDS is a validated,
patient-rated scale used to assess functional impairment in the
three domains of work/school, social life, and family life as a
result of psychiatric symptoms.
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. 9% of the 1583 patients
who received FETZIMA (40 mg - 120 mg) discontinued treatment due to
an AE, compared with 3% of the 1040 placebo-treated patients. The
only dose-related AEs (>2%) in the fixed-dose studies were
urinary hesitation and erectile dysfunction.
About Major Depressive Disorder
MDD is a serious medical condition often requiring treatment,
affecting almost 16 million adults in the United States yearly or
approximately 6.6% of the adult U.S. population. MDD, also known as
depression, is a common debilitating disorder in which feelings of
sadness and other symptoms occur nearly every day for at least two
weeks and interfere with a person’s ability to work, sleep, study,
eat, and enjoy once-pleasurable activities. Depression costs the
U.S. an estimated $83 billion each year. Among all medical
illnesses, MDD is a leading cause of disability in the U.S. The
World Health Organization predicts depression will become the
second leading cause of disability by the year 2020.
About FETZIMA
FETZIMA, an SNRI, is 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 and can be
taken with or without food.
The exact mechanism of 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 levomilnacipran is a potent and selective SNRI.
Levomilnacipran 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 lacks significant affinity for any other
receptors, ion channels, or transporters tested in vitro, including
serotonergic (5-HT1-7), α- and β-adrenergic, muscarinic, or
histaminergic receptors and Ca2+, Na+, K+, or Cl- channels.
Levomilnacipran was licensed to Forest Laboratories Inc. by
Pierre Fabre, in the U.S. and Canada. Pierre-Fabre will also be the
active pharmaceutical ingredient (API) supplier.
Visit FETZIMA.com for more information on this once-daily option
for the treatment of MDD in adults.
FETZIMA Indication and Usage
FETZIMA is a serotonin and norepinephrine reuptake inhibitor
(SNRI) indicated for the treatment of Major Depressive Disorder
(MDD) in adults.
FETZIMA is not approved for the management of fibromyalgia, and
its efficacy and safety have not been established for that use.
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.
FETZIMA is not approved for use in pediatric
patients.
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.
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 tachyarrhythmia’s 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.
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 and Its Products
Forest Laboratories (NYSE:FRX) is a leading, fully integrated,
specialty pharmaceutical company largely focused on the United
States market. The Company 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. Our strategy of acquiring product rights for
development and commercialization through licensing, collaborative
partnerships and targeted mergers and acquisitions allows us to
take advantage of attractive late-stage development and commercial
opportunities, thereby managing the risks inherent in drug
development. The Company is headquartered in New York, NY. To learn
more, visit www.FRX.com.
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 difficulty of predicting FDA approvals, the acceptance and
demand for new pharmaceutical products, the impact of competitive
products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, and any subsequent SEC filings. Forest assumes no obligation
to update forward-looking statements contained in this release to
reflect new information or future events or developments.
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Forest Laboratories, Inc.Frank J. Murdolo, 212-224-6714Vice
President – Investor Relationsmedia.relations@frx.com
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