Wyeth (Jobs) Receives Approvable Letter From FDA For Pristiq (Desvenlafaxine Succinate) For The Treatment Of Major Depressive Disorder
Published: Jan 24, 2007
MADISON, N.J., Jan. 23 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the Company has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Pristiq(TM) (desvenlafaxine succinate), a serotonin-norepinephrine reuptake inhibitor (SNRI) studied as a treatment for adult patients with major depressive disorder (MDD). The letter was received January 22.
"The approvable letter is in line with Wyeth's expectations and we remain on track with our plans for Pristiq," says Joseph Mahady, President, Wyeth Pharmaceuticals -- North America and Global Businesses. "We are working toward resolution of all outstanding issues at our manufacturing site in Guayama, Puerto Rico and have already made significant progress in meeting previously established commitments."
According to the approvable letter, FDA approval of Pristiq is subject to several conditions, including the following:
* A satisfactory FDA inspection of the Company's Guayama, Puerto Rico facility, which is where Pristiq will be manufactured * Several post-marketing commitments, including submission of long-term relapse prevention, low dose and pediatric studies * Additional clarity around the Company's product education plan for physicians and patients * Confirmation by the FDA of the acceptability of the proprietary name, Pristiq
As the Company has already communicated, launch timing for the MDD indication is predicated on three elements -- final FDA approval for Pristiq as a treatment for adult patients with MDD, the results of ongoing MDD studies at lower dosage levels, and the progress of FDA review of Wyeth's separate New Drug Application (NDA) for vasomotor symptoms (VMS) associated with menopause. Importantly, while the approvable letter requires some post-marketing commitments, the FDA does not require that any additional clinical studies be submitted prior to the approval of Pristiq.
"Given the importance of Pristiq, we are committed to ensuring the most complete profile and product information is available to physicians and patients at the time of this product's launch," Mahady says.
Pristiq is an SNRI studied as a potential treatment for adult men and women with MDD. Wyeth submitted a NDA for MDD on December 22, 2005. The Company has also filed a NDA for VMS associated with menopause and expects an FDA action letter in the second quarter of 2007. If approved, Pristiq will be the first and only non-hormonal medicine for the treatment of VMS associated with menopause. Wyeth is a leader in both neuroscience and women's health care.
Wyeth discovered and developed the first SNRI approved by the FDA, which is currently the most widely used antidepressant in the world. Pristiq represents Wyeth's latest efforts and continued commitment to developing therapies to help improve the lives of patients suffering from mental health disorders.
According to a large depression trial funded by the National Institute of Mental Health, only 28 percent of patients with depression achieved remission with initial antidepressant treatment. This leaves a large percentage of patients still suffering from depression. Clearly, additional medicines are needed for treating MDD.
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with major depressive disorder and other psychiatric disorders. Anyone considering the use of any antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are on such therapy should be 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 their prescriber.
About Major Depressive Disorder
Major depressive disorder is a serious medical condition that is different from "feeling blue" and is not something that people just "get over." Criteria for major depressive disorder include five or more of the following symptoms that have been present for at least two weeks, and at least one of the symptoms must be either depressed mood or loss of interest or pleasure.
* Depressed mood * Loss of interest or pleasure * Changes in appetite or weight * Changes in sleeping patterns * Psychomotor agitation or retardation * Fatigue or low energy * Feeling worthless or guilty for no reason * Difficulty thinking or concentrating * Thoughts of death or suicide
Further, people with major depressive disorder may experience clinically significant distress or impairment in social, occupational or other important areas of functioning. If a person experiences these symptoms, he or she should speak with a health care professional.
Major depressive disorder is a common mental disorder, affecting about 121 million people worldwide. In the United States, it is estimated that depression affects about 19 million American adults each year. The lifetime risk of major depression has been assessed from 10 to 25 percent for women and five to 12 percent for men. Research has shown that hormonal changes, including estrogen decline, or life stressors experienced by women may contribute to a major depressive episode.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third party-payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors." We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
For more information, visit www.wyeth.com .Wyeth Pharmaceuticals
CONTACT: Gwen Fisher of Wyeth Pharmaceuticals, +1-484-865-5160, Mobile,+1-215-407-1548; or Doug Petkus, +1-973-660-5218, or Investor Contact,Justin Victoria, +1-973-660-5340, both of Wyeth
Web site: http://www.wyeth.com/