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 placebo.
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.
About PRISTIQ
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.
Indication
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 side effects.
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 dose.
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.
INDICATION
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.
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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 developments.
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 and www.pfizer.com.
