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Cypress' Comprehensive Review of the Psychopharmacology of Fibromyalgia Syndrome Featured in Psychopharmacology Bulletin.


Business Editors & Health/Medical Writers

SAN DIEGO--(BW HealthWire)--Feb. 14, 2002

Cypress Bioscience Inc. (Nasdaq:CYPB) announced today the publication of a review article entitled "The Psychopharmacology psychopharmacology (sī'kōfär'məkŏl`əjē), in its broadest sense, the study of all pharmacological agents that affect mental and emotional functions.  of Fibromyalgia fibromyalgia

Chronic syndrome that is characterized by musculoskeletal pain, often at multiple sites. The cause is unknown. A significant number of persons with fibromyalgia also have mental disorders, especially depression.
: A Drug Development Perspective," authored by Cypress employees, which is featured in the winter 2002 volume of Psychopharmacology Bulletin.

The review, lead-authored by Jay D. Kranzler, M.D., Ph.D., Cypress' chairman of the board and chief executive officer, summarizes our current understanding of the pathophysiology pathophysiology /patho·phys·i·ol·o·gy/ (-fiz?e-ol´ah-je) the physiology of disordered function.

path·o·phys·i·ol·o·gy
n.
1.
 of FMS FMS - Flexible Manufacturing System (factory automation). , with an emphasis on identifying bases for the development of novel therapeutic agents. The article includes a critical review of the existing clinical literature supporting the use of various pharmaceutical agents to treat the condition, as well as proposing several novel approaches based on more recent progress.

"This much needed review is the most comprehensive in the psychiatric literature," commented John Docherty, M.D., president and chief executive officer of Comprehensive NeuroScience Inc. "FMS may share some important biological processes with both major depressive disorder Major depressive disorder
A mood disorder characterized by profound feelings of sadness or despair.

Mentioned in: Conduct Disorder

major depressive disorder 
 and neuropathic pain. This review provides an overview of those similarities and outlines the lessons learned for novel drug discovery in the field. Its publication in a journal such as Psychopharmacology Bulletin underscores the growing recognition of this area."

"This is just further evidence of Cypress's strong commitment to understanding the science behind FMS, and using this knowledge to identify the most effective pharmacologic therapies for this condition," remarked Daniel J. Clauw, M.D., director, Georgetown Chronic Pain and Fatigue Research Center.

FMS is a chronic and debilitating de·bil·i·tat·ing
adj.
Causing a loss of strength or energy.


Debilitating
Weakening, or reducing the strength of.

Mentioned in: Stress Reduction
 condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue and headache. It affects an estimated 2%-4% of the population worldwide and is the second most common diagnosis by rheumatologists in the U.S. after osteoarthritis osteoarthritis
 or osteoarthrosis or degenerative joint disease

Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first.
. Despite the high prevalence and severity of this syndrome, today there are no approved treatments specifically for FMS.

Cypress is developing a drug called milnacipran, an approved anti-depressant in 13 countries, for treatment of FMS. Milnacipran, the first of a new class of agents known as NSRI's, or Norepinephrine norepinephrine (nôr'ĕpīnĕf`rən), a neurotransmitter in the catecholamine family that mediates chemical communication in the sympathetic nervous system, a branch of the autonomic nervous system.  Serotonin Reuptake reuptake /re·up·take/ (re-up´tak) reabsorption of a previously secreted substance.

re·up·take
n.
 Inhibitors, shares a pharmacological profile with the tricyclic antidepressants (TCAs), considered the most effective drugs for treatment of FMS, while lacking the side effects associated with the latter. Unlike the related SNRI's, or Serotonin Norepinephrine Reuptake Inhibitors, such as venlafaxine venlafaxine /ven·la·fax·ine/ (ven?lah-fak´sen) an inhibitor of serotonin and norepinephrine reuptake that potentiates neurotransmitter activity in the central nervous system; used as the hydrochloride salt as an antidepressant and  or duloxetine, the NSRI's are similar to the TCAs, in that their effect is more pronounced on a neurotransmitter known as norepinephrine (NE) than is their effect on a neurotransmitter known as serotonin (5-HT). Cypress filed an investigational new drug application (IND) in December 2001 with the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) that is now open, with Phase II testing planned to begin shortly.

About Cypress Bioscience Inc.

Cypress is committed to be the innovator and commercial leader in providing products that improve the diagnosis and treatment of patients with FMS. In January 2001, the company began a strategic initiative focusing on FMS. In August 2001, Cypress licensed its first product for clinical development, milnacipran, to treat the widespread pain associated with FMS. In January of 2002, the company's IND was opened to commence a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II
 to treat FMS with milnacipran in the United States. For more information about Cypress, visit the company's Web site at www.cypressbio.com. For more information about FMS, visit www.FMSresource.com.

This press release, as well as Cypress' SEC filings and Web site at http://www.cypressbio.com, contain forward-looking statements regarding the company's continued listing of the company's securities on The Nasdaq SmallCap Market, within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress Annual Report on Form 10-K and any subsequent SEC filings. In addition, there is the risk that we may not be able to successfully develop or market any products for the treatment of FMS under the Pierre Fabre agreement or at all; that our clinical development plan or timeline for milnacipran may be delayed, including our plan to begin treating patients in a Phase II clinical trial in early 2002; that we may encounter regulatory or other difficulties in the development of milnacipran for FMS; that milnacipran may not significantly improve the treatment of FMS, that we will not be successful in identifying or developing products under the Georgetown agreement; that Fresenius may not be able to successfully market the PROSORBA column; and that we may not receive any future royalties under our revised agreement with Fresenius. Cypress undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
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Geographic Code:1USA
Date:Feb 14, 2002
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