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Forest And Cypress Announce Submission Of New Drug Application For Milnacipran For The Treatment Of Fibromyalgia Syndrome
Forest
Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB)
announced that they have recently submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for milnacipran, a unique
dual-reuptake inhibitor being developed for the treatment of fibromyalgia
syndrome (FMS).
FMS is defined by widespread chronic pain, as well as a broad spectrum
of related symptoms including fatigue, cognitive dysfunction, and reduced
physical function. The NDA for milnacipran is based on a composite
responder analysis that requires each patient to experience concurrent and
clinically meaningful improvements in three validated measures: pain,
patient global impression of change in disease status, and physical
function. This approach is considered a more stringent assessment of
therapeutic effect than the evaluation of individual symptoms.
The submission includes efficacy data from two pivotal Phase III trials
involving 2,084 patients (1,460 milnacipran, 624 placebo), which showed
that milnacipran demonstrated improvement compared to placebo in treating
FMS. Moreover, safety data collected from 2,209 patients (1,557
milnacipran, 652 placebo) during the development program demonstrated that
milnacipran was generally well tolerated with the majority of adverse
events reported as mild to moderate in nature.
About Milnacipran
Milnacipran is a unique dual-reuptake inhibitor, which preferentially
blocks the reuptake of norepinephrine with higher potency than serotonin,
two neurotransmitters known to play an essential role in regulating pain
and mood. It has been approved for a non-pain condition in over 50
countries, with real-world commercial experience outside the U.S. for 10
years. Milnacipran is jointly being developed for fibromyalgia syndrome in
the United States market by Forest and its licensor, Cypress Bioscience,
Inc. Milnacipran was originally developed by and is sold outside of the
U.S. by Pierre Fabre Medicament.
About Fibromyalgia
FMS is a chronic and debilitating condition characterized by widespread
pain and stiffness throughout the body, accompanied by severe fatigue,
insomnia and mood symptoms. According to the American College of
Rheumatology, FMS is estimated to affect over six million people in the
United States. FMS is most often diagnosed in the primary care setting and,
in addition, is the second most commonly diagnosed condition in
rheumatology clinics in the United States after osteoarthritis. Despite the
high prevalence and severity of this syndrome, there are limited treatment
options specifically approved for FMS in the United States or elsewhere,
and the addressable patient population is not yet well established.
About Forest Laboratories and Its Products
Forest Laboratories (http://www.frx.com) is a US-based pharmaceutical company
dedicated to identifying, developing and delivering products that make a
positive difference in peoples' lives. Forest Laboratories' growing product
line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the initial and maintenance treatment of major depressive
disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl D-aspartate (NMDA)-receptor antagonist indicated for the treatment
of moderate to severe Alzheimer's disease; Campral(R)* (acamprosate
calcium), indicated in combination with psychosocial support for the
maintenance of abstinence from alcohol in patients with alcohol dependence
who are abstinent at treatment initiation, and Bystolic(TM) (nebivolol), a
beta-adrenergic receptor blocking agent indicated for the treatment of
hypertension. In addition to our growing product line, Forest also
co-promotes the Daiichi Sankyo, Inc. products Benicar(R) (olmesartan
medoxomil), an angiotensin receptor blocker, Benicar HCT(R) (olmesartan
medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and
diuretic combination product, and Azor(TM)* (amlodipine and olmesartan
medoxomil) a calcium channel blocker and angiotensin receptor blocker
combination product, all indicated for the treatment of hypertension.
Azor is a trademark of Daiichi Sankyo, Inc.; Benicar and Benicar HCT
are registered trademarks of Daiichi Sankyo, Inc.; and Campral is a
registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed form time to time in
the Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on
Form 10-Q, and any subsequent SEC filings.
About Cypress
Cypress is committed to being an innovator and leader in providing
products for the treatment of patients with Fibromyalgia Syndrome. As part
of its business development strategy, the company evaluates a number of
Proof of Concept stage opportunities that leverage its repurposing
experience and innovative approach to clinical trial design and regulatory
strategy, and intend to continue to do this on an ongoing basis. The
company continues to evaluate various other potential strategic
transactions, including the potential acquisition of products, product
candidates, technologies and companies.
For more information about Cypress, please visit Cypress' website at
http://www.cypressbio.com.
This press release, as well as Cypress' SEC filings and website at
http://www.cypressbio.com, contain forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 including
statements about the potential of milnacipran to treat fibromyalgia
syndrome and our NDA filing for milnacipran. 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, the most
recent Quarterly Report on Form 10-Q and any subsequent SEC filings and
including, but not limited to, that more detailed analysis of the trial
results may not be favorable or may lead to different conclusions; that the
NDA may not be accepted and even if accepted by the FDA, that the NDA may
not ultimately be approved by the FDA.
Forest Laboratories, Inc.
http://www.frx.com
View drug information on Benicar; Campral.
Pãdure ºi Cypress Anunþarea prezentarea unor noi Drug Cerere pentru Milnacipran pentru tratamentul Fibromyalgia Sindromul - Forest And Cypress Announce Submission Of New Drug Application For Milnacipran For The Treatment Of Fibromyalgia Syndrome - articole medicale engleza - startsanatate