NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced the top line results from a Phase 3
study which evaluated the efficacy, safety, and tolerability of Pristiq® (desvenlafaxine
succinate sustained-release formulation) in pediatric patients ages 7 to
17 with Major Depressive Disorder (MDD).
The study did not meet its primary objective to demonstrate superior
efficacy of desvenlafaxine succinate sustained-release formulation
compared to placebo.
This is the second of two Phase 3 placebo controlled studies conducted
as part of an FDA post-marketing commitment under the Pediatric Research
Equity Act (PREA). Desvenlafaxine did not demonstrate superior efficacy
compared to placebo in either study.
About the Study
The study was a randomized, double-blind, placebo-controlled, study
designed to evaluate the efficacy, safety, and tolerability of
desvenlafaxine succinate sustained-release formulation in pediatric
outpatients ages 7 to 17 with MDD. A total of 363 subjects were
randomized. The patient population was comprised of 30 percent children
(7-11 years of age) and 70 percent adolescents (12-17 years of age).
This study included three treatment arms: desvenlafaxine succinate
sustained-release formulation low dose exposure (weight-based dosing to
achieve pediatric exposures approximating exposures in adults receiving
25 mg/day), desvenlafaxine succinate sustained-release formulation high
dose exposure (weight-based dosing to achieve pediatric exposures
approximating exposures in adults receiving 35 mg/day), and placebo.
Efficacy results indicate that both desvenlafaxine succinate
sustained-release formulation low dose exposure and high dose exposure
treatment arms were not statistically significantly different from
There were no new safety signals identified. Adverse events occurring
after the start of treatment in the desvenlafaxine succinate
sustained-release formulation group were generally consistent with those
observed in both the Phase 2a pediatric MDD safety studies and the
studies of desvenlafaxine succinate sustained-release
formulation-treated adults with MDD.
Full results from the study will be submitted for publication.
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. 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.
PRISTIQ Extended-Release Tablets are indicated for the treatment of
major depressive disorder in adults.
Important Safety Information About PRISTIQ
Suicidality and Antidepressant Drugs. Antidepressants increased the
risk of suicidal thinking and behavior in children, teens, and young
adults. 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 or when the dose is
changed should be monitored appropriately and observed closely for
clinical worsening, suicidality, or unusual changes in behavior such as
becoming agitated, irritable, hostile, aggressive, impulsive, or
restless. Should these occur, report them to a doctor right away.
PRISTIQ is not approved for use in children under 18.
Do not take PRISTIQ if you are allergic to desvenlafaxine, venlafaxine,
or any of the ingredients in PRISTIQ. Do not take PRISTIQ if you
currently take, or have taken within the last 14 days, any medicine
known as an MAOI (including intravenous methylene blue or the antibiotic
linezolid). Allow 7 days after stopping PRISTIQ before starting an MAOI.
Taking an MAOI with PRISTIQ can cause serious or even life-threatening
Before taking PRISTIQ, tell your healthcare professional about all
prescription and over-the-counter medications and supplements you take
or plan to take including: those to treat migraines or psychiatric
disorders (including other antidepressants) to avoid serotonin syndrome,
a potentially life-threatening condition; aspirin, NSAID pain relievers,
or blood thinners because they may increase the risk of bleeding.
PRISTIQ may cause or worsen some conditions, so tell your healthcare
professional about all the medical conditions you have or had including:
• High blood pressure, which should be controlled before starting
PRISTIQ and monitored regularly
• Heart problems, high cholesterol or triglyceride levels, a history of
stroke, kidney or liver problems, or low sodium levels in your blood
• Bleeding problems
• Depression, suicidal thoughts or behavior
• Mania, bipolar disorder, or seizures or convulsions
• Nursing, pregnancy, or plans to become pregnant
Some people are at risk for visual problems such as eye pain, changes in
vision, or swelling or redness around the eye. You may want to undergo
an eye examination to see if you are at risk and get preventative
treatment if you are.
Discontinuation symptoms may occur when stopping or reducing PRISTIQ, so
talk to your healthcare professional before stopping or changing your
Until you see how PRISTIQ affects you, be careful driving a car or
operating machinery. Avoid drinking alcohol while taking PRISTIQ.
In clinical studies, most common side effects with PRISTIQ 50 mg were
nausea, dizziness, sweating, constipation, and decreased appetite.
PRISTIQ (desvenlafaxine) is a prescription medication approved for the
treatment of major depressive disorder in adults.
Full prescribing information and Medication Guide including BOXED
WARNING, are available at www.PRISTIQ.com.
Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world’s
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world’s
premier innovative biopharmaceutical companies, we collaborate with
health care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world. For
more than 150 years, Pfizer has worked to make a difference for all who
rely on us. To learn more, please visit us at www.pfizer.com.
In addition, to learn more, follow us on Twitter at @Pfizer and
@Pfizer_News, and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release
is as of December 21, 2015. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result of
new information or future events or developments.
This release contains forward-looking information about Pristiq®
(desvenlafaxine succinate sustained-release formulation) that involves
substantial risks and uncertainties that could cause actual results to
differ materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, the uncertainties
inherent in research and development, including, without limitation, the
possibility of unfavorable clinical trial results; and competitive
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended December
31, 2014 and in its subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results,” as well as in
its subsequent reports on Form 8-K, all of which are filed with the U.S.
Securities and Exchange Commission and available at www.sec.gov