Pfizer Announces Top-Line Efficacy Results From A Phase 4 Study Of PRISTIQ®
(desvenlafaxine) For The Treatment Of Major Depressive Disorder (MDD) In
New Data Add to Evidence Supporting PRISTIQ as a Treatment Option for MDD
NEW YORK -- January 24, 2013
Pfizer Inc. (NYSE: PFE) announced today that a Phase 4 study evaluating the
efficacy of PRISTIQ^® (desvenlafaxine) Extended Release Tablets met its
primary endpoint. The study supports the efficacy of 50 mg/day and 100 mg/day
doses of PRISTIQ compared with placebo over eight weeks of treatment in adult
patients with major depressive disorder (MDD) as measured by the 17-item
Hamilton Rating Scale for Depression (HAM-D17) total score.^1
In this study, the most common treatment-emergent adverse events observed were
consistent with the known safety and tolerability profile of PRISTIQ.^1
"These positive top-line results add to the growing body of evidence that
supports PRISTIQ as a treatment option for adults with major depressive
disorder," said Steven J. Romano, M.D., senior vice president, head of
Medicines Development Group, Global Primary Care Business Unit, Pfizer Inc.
“We know how challenging it can be to treat and manage major depressive
disorder. We continue to study PRISTIQ in order to provide clinicians with
more information that can better guide their treatment decisions for MDD
The Phase 4 study was designed as a multi-center, randomized, double-blind,
placebo-controlled, eight-week, parallel group study in adult patients with
MDD.^1 The primary efficacy endpoint was the change from baseline in HAM-D17
total score at week eight.^1 The HAM-D17 is a validated assessment tool used
to rate the severity of a patient's major depressive symptoms.^2 The study
enrolled 924 patients who were randomized in a 1:1:1 ratio to one of the
following treatment arms: PRISTIQ 50 mg/day, PRISTIQ 100 mg/day or placebo.^1
Results from this PRISTIQ Phase 4 study will be submitted for presentation at
upcoming scientific congresses and for publication in a peer-reviewed medical
About Major Depressive Disorder (MDD)
An estimated 33 to 35 million U.S. adults are likely to experience major
depression at some point during their lifetime.^3 The criteria for MDD include
having five or more of the symptoms of depression listed below during the same
two-week period and representing a change from previous functioning. Depressed
mood or diminished interest or pleasure must be among the depression symptoms
reported from the following list: depressed mood; diminished interest or
pleasure; significant weight loss or change in appetite; insomnia/hypersomnia;
psychomotor agitation; fatigue or loss of energy; feelings of worthlessness or
excessive/inappropriate guilt; difficulty concentrating; and recurrent
thoughts of death.^4
About PRISTIQ^® (desvenlafaxine)
PRISTIQ, a selective serotonin and norepinephrine reuptake inhibitor (SNRI),
is a prescription medication that was approved by the U.S. Food and Drug
Administration (FDA) in 2008 for the treatment of MDD in adults.^5 The
recommended dose for PRISTIQ is 50 mg once daily, with or without food. In
clinical studies, doses of 50-400 mg/day were shown to be effective, although
no additional benefit was demonstrated at doses greater than 50 mg/day and
adverse events and discontinuations were more frequent at higher doses.^5
Important Safety Information About PRISTIQ
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking
and behavior (suicidality) in children, adolescents and young adults in
short-term studies of Major Depressive Disorder (MDD) and other psychiatric
disorders. Anyone considering the use of PRISTIQ or any other antidepressant
in a child, adolescent or young adult must balance this risk with the clinical
need. Short-term studies did not show an increase in the risk of suicidality
with antidepressants compared to placebo in adults beyond age 24; there was a
reduction in risk with antidepressants compared to placebo in adults aged 65
and older. Depression and certain other psychiatric disorders are themselves
associated with increases in the risk of suicide. Patients of all ages who are
started on antidepressant therapy should be monitored appropriately and
observed closely for clinical worsening, suicidality or unusual changes in
behavior. Families and caregivers should be advised of the need for close
observation and communication with the prescriber. PRISTIQ is not approved for
use in pediatric patients.
*PRISTIQ is contraindicated in patients with a known hypersensitivity to
PRISTIQ or venlafaxine.
*Serotonin syndrome and MAOIs: Do not use monoamine oxidase inhibitors
(MAOIs) intended to treat psychiatric disorders with PRISTIQ or within
seven days of stopping treatment with PRISTIQ. Do not use PRISTIQ within
14 days of stopping an MAOI intended to treat psychiatric disorders. In
addition, do not start PRISTIQ in a patient who is being treated with an
MAOI such as linezolid or intravenous methylene blue.
Selected 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.
*The development of a potentially life-threatening serotonin syndrome has
been reported with selective serotonin reuptake inhibitors (SSRIs) and
serotonin and norepinephrine reuptake inhibitors (SNRIs), including with
PRISTIQ, 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). If such events occur,
immediately discontinue PRISTIQ and any concomitant serotonergic agents,
and initiate supportive treatment. If concomitant use of PRISTIQ with
other serotonergic drugs is clinically warranted, patients should be made
aware of a potential increased risk for serotonin syndrome, particularly
during treatment initiation and dose increase.
*Patients receiving PRISTIQ should have regular monitoring of blood
pressure since increases in blood pressure were observed in clinical
studies. Pre-existing hypertension should be controlled before starting
PRISTIQ. Caution should be exercised in treating patients with
pre-existing hypertension or other underlying conditions that might be
compromised by increases in blood pressure. Cases of elevated blood
pressure requiring immediate treatment have been reported. For patients
who experience a sustained increase in blood pressure, either dose
reduction or discontinuation should be considered.
*SSRIs and SNRIs, including PRISTIQ, may increase the risk of bleeding
events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs
(NSAIDs), warfarin and other anticoagulants may add to this risk.
*Mydriasis has been reported in association with PRISTIQ; therefore,
patients with raised intraocular pressure or those at risk of acute
narrow-angle glaucoma (angle-closure glaucoma) should be monitored.
*PRISTIQ is not approved for use in bipolar depression. Prior to initiating
treatment with an antidepressant, patients should be adequately screened
to determine the risk of bipolar disorder.
*PRISTIQ should be used cautiously in patients with a history or family
history of mania or hypomania or with a history of seizure disorder.
*Caution is advised in administering PRISTIQ to patients with
cardiovascular, cerebrovascular or lipid metabolism disorders. Increases
in blood pressure and small increases in heart rate were observed in
clinical studies with PRISTIQ. PRISTIQ has not been evaluated
systematically in patients with a recent history of myocardial infarction,
unstable heart disease, uncontrolled hypertension or cerebrovascular
*Dose-related elevations in fasting serum total cholesterol, low-density
lipoprotein (LDL) cholesterol and triglycerides were observed in clinical
studies. Measurement of serum lipids should be considered during PRISTIQ
*On discontinuation, adverse events, some of which may be serious, have
been reported with PRISTIQ and other SSRIs and SNRIs. Abrupt
discontinuation of PRISTIQ has been associated with the appearance of new
symptoms. Patients should be monitored for symptoms when discontinuing
treatment. A gradual reduction in dose rather than abrupt cessation is
recommended whenever possible.
*The recommended dose in patients with severe renal impairment or end-stage
renal disease (ESRD) is 50-mg every other day. The dose should not be
escalated in patients with moderate or severe renal impairment or ESRD.
*Products containing desvenlafaxine and products containing venlafaxine
should not be used concomitantly with PRISTIQ.
*Hyponatremia may occur as a result of treatment with SSRIs and SNRIs,
including PRISTIQ. Discontinuation of PRISTIQ should be considered in
patients with symptomatic hyponatremia.
*Interstitial lung disease and eosinophilic pneumonia associated with
venlafaxine (the parent drug of PRISTIQ) therapy have been rarely
*Adverse reactions in patients in short-term, fixed-dose studies (incidence
≥5% and twice the rate of placebo in the 50 mg or 100 mg dose groups)
were: nausea, dizziness, insomnia, hyperhidrosis, constipation,
somnolence, decreased appetite, anxiety and specific male sexual function
Full prescribing information and Medication Guide are available at
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^1 Pfizer, Inc. Data on file.
^2 American Psychiatric Association. Practice Guideline for the Treatment of
Patients with Major Depressive Disorder. Third Edition. Arlington, VA,
American Psychiatric Association, 2010.
^3 Kessler RC, Berglund P, Demler O, et al. The epidemiology of major
depressive disorder: results from the National Comorbidity Survey Replication
(NCS-R). JAMA. 2003; 289(23):3095-3105.
^4 American Psychiatric Association: Diagnostic and Statistical Manual of
Mental Disorders, Fourth Edition, Text Revision. Washington, DC, American
Psychiatric Association, 2000.
^5 PRISTIQ^® (desvenlafaxine) Extended Release Tablets Prescribing
Information, Pfizer, Inc. Philadelphia, PA.
Jennifer Kokell, 212-733-2596
Suzanne Harnett, 212-733-8009
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