Wyeth Pharmaceuticals’ PRISTIQ (desvenlafaxine), a new serotonin-norepinephrine reuptake inhibitor (SNRI) approved to treat adult patients with major depressive disorder (MDD), is now available in U.S. retail pharmacies nationwide. The recommended dose of PRISTIQ is 50 milligrams (mg) once daily. The Company begins full-scale selling and educational efforts regarding PRISTIQ for physicians this week.
%26quot;We are proud to make PRISTIQ available as a new treatment option for the millions of American adults who struggle with depression,%26quot; comments Philip Ninan, M.D., Vice President, Wyeth Medical Affairs, Neuroscience. %26quot;The recommended therapeutic dose of PRISTIQ is 50 mg once daily. Titration is not required to reach the recommended therapeutic dose.%26quot; Dosage adjustment (50 mg every other day) is necessary, however, in patients with severe renal impairment or end-stage renal disease.
PRISTIQ, an SNRI approved by the U.S. Food and Drug Administration on February 29, 2008, is an important new treatment option for the millions of adults in the United States who have MDD. Discovered and developed by Wyeth, PRISTIQ demonstrates the Company’s significant and continued commitment to developing new therapies in the field of neuroscience.
At the recommended dose of 50 mg, the discontinuation rate due to an adverse experience for PRISTIQ (4.1 percent) was similar to the rate for placebo (3.8 percent) in clinical studies. The most commonly observed adverse reactions in patients taking PRISTIQ for MDD in short-term, fixed-dose studies (incidence greater than or equal to 5 percent and at least twice the rate of placebo in the 50 mg dose groups) were nausea, dizziness, hyperhidrosis, constipation and decreased appetite.
About Major Depressive Disorder
Major depressive disorder (MDD) is a common mental disorder, affecting about 121 million people worldwide. In the United States, MDD affects approximately 15 million adults, or 6.7 percent of the U.S. population age 18 and older in a given year. In fact, depression is among the leading causes of disability and the fourth leading contributor to the global burden of disease. Further, a research study estimated that the total economic burden of depression was $83.1 billion in 2000, including direct treatment costs and suicide- and work-related costs.
Important Treatment Considerations
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.