NEW YORK and SAN DIEGO, April 20, 2009 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) announced today that Savella(TM) (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor approved for the management of fibromyalgia, will be shipped to wholesalers on April 24th and will be available at pharmacies beginning on April 28th. After Savella was approved by the U.S. Food and Drug Administration (FDA) on January 14, 2009, the companies submitted a minor post-approval cosmetic formulation change to the FDA which now has been approved.
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About Savella
Savella was approved by the FDA on January 14, 2009 for the management of fibromyalgia, a chronic condition characterized by widespread pain and decreased physical function that afflicts as many as six million people in the United States. Savella is a dual-reuptake inhibitor that, in-vitro, preferentially blocks the reuptake of norepinephrine with higher potency than serotonin, two neurotransmitters thought to a play a central role in the symptoms of fibromyalgia. Savella will be marketed by Forest and its licensor, Cypress Bioscience. Pierre Fabre, who originally developed and sells milnacipran outside the U.S., licensed the rights for North America to Cypress Bioscience.
Important Safety Information
Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. 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 such drugs 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 Savella 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. Savella is not approved for use in the treatment of major depressive disorder.
