Wyeth's Pristiq: New Treatment For Major Depression

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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.

"We are proud to make PRISTIQ available as a new treatment option for the millions of American adults who struggle with depression," comments Philip Ninan, M.D., Vice President, Wyeth Medical Affairs, Neuroscience. "The recommended therapeutic dose of PRISTIQ is 50 mg once daily. Titration is not required to reach the recommended therapeutic dose." Dosage adjustment (50 mg every other day) is necessary, however, in patients with severe renal impairment or end-stage renal disease.

About PRISTIQ

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.

* PRISTIQ is not approved for use in pediatric patients.

Contraindications

* PRISTIQ is contraindicated in patients with a known hypersensitivity to PRISTIQ or venlafaxine.

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* PRISTIQ must not be used concomitantly with an MAOI or within 14 days of stopping an MAOI. Allow 7 days after stopping PRISTIQ before starting an MAOI.

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.

* Development of a potentially life-threatening serotonin syndrome may occur with SNRIs and SSRIs, including PRISTIQ, particularly with concomitant use of serotonergic drugs, including triptans, and with drugs that impair the metabolism of serotonin (including MAOIs). If concomitant use is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Concomitant use of PRISTIQ with serotonin precursors is not recommended.

* Patients receiving PRISTIQ should have regular monitoring of blood pressure since sustained 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, 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.

* As with all antidepressants, 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 disease.

* Dose-related elevations in fasting serum total cholesterol, LDL (low density lipoprotein) cholesterol, and triglycerides were observed in clinical studies. Measurement of serum lipids should be considered during PRISTIQ treatment.

* 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 (by giving 50 mg of PRISTIQ less frequently) rather than abrupt cessation is recommended whenever possible.

* Dosage adjustment (50 mg every other day) is necessary in patients with severe renal impairment or end-stage renal disease (ESRD). 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 reported.

Adverse Reactions

* The most commonly observed adverse reactions in patients taking PRISTIQ vs placebo for MDD in short-term fixed-dose premarketing studies (incidence greater than or equal to 5% and twice the rate of placebo in the 50-mg dose group) were nausea (22% vs 10%), dizziness (13% vs 5%), hyperhidrosis (10% vs 4%), constipation (9% vs 4%), and decreased appetite (5% vs 2%).

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