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Fda approves pristiq(tm) with the therapy for adult patients with major depressive... -- re>
madison, n. j. , feb. 29 /prnewswire-firstcall/ --
MADISON, N. J. , Feb. 29 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals,
a division of Wyeth (NYSE: WYE), announced today the U. S. Food and
Drug Administration (FDA) has approved PRISTIQ(TM) (desvenlafaxine), a
structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor
(SNRI), to take care of adult patients with major despression symptoms (MDD). Wyeth
expects to start out shipping PRISTIQ to wholesalers starting in your second
quarter of 2008. "We are pleased so as to bring PRISTIQ to patients," says Bernard
Poussot, President and Ceo of Wyeth. "PRISTIQ is
Wyeth's fourth new drug to obtain approval within the last twelve months,
demonstrating our capacity to achieve success through the rigorous
scientific technique of discovery and development. We look forward to working
with FDA along with other regulatory authorities worldwide to remain to
bring important new medicines to patients who are required them. "
"PRISTIQ is a new therapeutic choice for patients and
clinicians because not one therapy utilizes everybody with major
depression," says Philip Ninan, M. D. , Vice President of Wyeth Medical
Affairs, Neuroscience. "PRISTIQ qualifies with a once-daily 50-mg dose that
does not require titration, allowing physicians to begin with their patients at
the recommended therapeutic dose. We are encouraged through the tolerability
profile found in clinical studies. "
FDA approval was at the mercy of several post-marketing commitments,
including conducting and submitting data from a new long-term maintenance
(relapse prevention) study, a impotence study, pediatric studies
and also a study exploring lower doses. The company also requested one more
non-clinical toxicity study. The efficacy of PRISTIQ being a answer to depression was established
in four 8-week, randomized, double-blind, placebo-controlled, fixed-dose
studies in adult outpatients who met the Diagnostic and Statistical Manual
of Mental Disorders (DSM-IV) criteria for MDD. In the recommended dose of
50 mg, the discontinuation rate as a result of a negative experience for PRISTIQ
(4. One percent) was similar to the speed for placebo (3. 8 percent). Uncomfortable side effects of many antidepressant therapies might cause some patients
to avoid taking their medication. One of the most commonly observed adverse
reactions in patients taking PRISTIQ for MDD in short-term, fixed-dose
studies (incidence more than or corresponding to 5 percent and a minimum of twice
the rate of placebo inside 50 or 100 mg dose groups) were nausea,
dizziness, insomnia, hyperhidrosis, constipation, somnolence (sleepiness),
decreased appetite, anxiety, and specific male sexual function disorders. About PRISTIQ
PRISTIQ delivers the major active metabolite of EFFEXOR XR(R)
(venlafaxine HCl) to use active state without checking CYP2D6
metabolic pathway. This could be beneficial when PRISTIQ is coadministered
to commonly prescribed medications metabolized utilizing
pathway. EFFEXOR XR, discovered and manufactured by Wyeth, was the first SNRI
authorized by the FDA for MDD and is currently the most widely prescribed
antidepressant on the planet. PRISTIQ, also discovered and created by Wyeth, demonstrates the
Company's significant and continued deal with developing new therapies
in neuroscience. About Major Depressive Disorder
Major depressive disorder (MDD) is a type of mental disorder, affecting
about 121 million people worldwide. In america, MDD affects
approximately 15 million adults, or 6. 7 percent of the U. S. population age
18 and older within a given year. In fact, depression is one of the leading
factors that cause disability plus the fourth leading cause of the global
burden of disease. Further, an exploration 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. MDD can be a serious medical condition that may be totally different from "feeling
blue" and isn't an issue that people just "get over. " Criteria for MDD
include five or maybe more with the following symptoms which are present for
a minimum of a couple weeks, and at least one of many symptoms need to be either
depressed mood or loss in interest or pleasure: depressed mood; decrease in
interest or pleasure; alterations in appetite or weight; adjustments to sleeping
patterns; psychomotor agitation or retardation; fatigue or low energy;
feeling worthless or guilty for absolutely no reason; difficulty thinking or
concentrating; or thoughts of death or suicide. Further, individuals with MDD
must experience clinically significant distress or impairment in social,
occupational or any other important aspects of functioning.

Important Treatment Ways to care for Antidepressants
Suicidality and Antidepressant Drugs
-- Antidepressants increased the chance when compared with 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. -- Depression and certain other psychiatric disorders are themselves
linked to increases in the chance suicide. -- Patients spanning various ages who are moving on antidepressant therapy should
be monitored appropriately and observed closely for clinical worsening,
suicidality, or unusual alterations in behavior, particularly if starting
therapy or sometimes of dose changes. -- PRISTIQ just isn't approved to use in pediatric patients. Important Treatment Things to consider for PRISTIQ
-- PRISTIQ is indicated for your therapy for major depressive disorder in
adults buy celebrex online. Contraindications
-- PRISTIQ is contraindicated in patients which has a known hypersensitivity to
PRISTIQ or venlafaxine. -- PRISTIQ should not be used concomitantly with the MAOI or within Fourteen days
of stopping an MAOI. Allow 7 days after stopping PRISTIQ before
getting MAOI. Warnings and Precautions
-- All patients cured with antidepressants should be monitored
appropriately and observed closely for clinical worsening, suicidality,
and unusual adjustments to behavior, especially throughout the initial 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 disorders, insomnia, irritability,
hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or
suicidality that happen to be severe, abrupt in onset, or are not portion of the
patient's presenting symptoms. Families and caregivers of patients
receiving care with antidepressants needs to be alerted around the ought to
monitor patients. -- Development of a potentially life-threatening serotonin syndrome may
occur with SNRIs and SSRIs, including PRISTIQ, particularly with
concomitant by using serotonergic drugs, including triptans. If
concomitant use is clinically warranted, careful observation on the
patient is recommended, particularly during treatment initiation and dose
increases. Concomitant usage of PRISTIQ with serotonin precursors is just not
recommended. -- Patients receiving PRISTIQ ought to have regular monitoring of blood
pressure since sustained increases in hypertension were witnessed in
clinical studies. Pre-existing hypertension needs to be controlled before
starting PRISTIQ. Caution ought to be exercised for patients with
pre-existing hypertension and other underlying conditions may very well be
compromised by increases in high blood pressure. Cases of elevated blood
pressure requiring immediate treatment are already reported. -- SSRIs and SNRIs, including PRISTIQ, could raise the probability of bleeding
events. Concomitant utilization of aspirin, NSAIDs, warfarin, along with other
anticoagulants will add to this risk. -- Mydriasis has been reported in colaboration with PRISTIQ; therefore,
patients with raised intraocular pressure or those susceptible to acute
narrow-angle glaucoma (angle-closure glaucoma) ought to be monitored. -- As with most antidepressants, PRISTIQ should be used cautiously in
patients having a history or genealogy and family history of mania or hypomania. -- Caution is required in administering PRISTIQ to patients with
cardiovascular, cerebrovascular, or lipid metabolism disorders. Increases in blood pressure and small increases in heartbeat were
noticed in scientific tests with PRISTIQ. -- Dose-related elevations in fasting serum total cholesterol, LDL (low
density lipoprotein) cholesterol, and triglycerides were noticed in
scientific tests. Measurement of serum lipids should be considered
during PRISTIQ treatment. -- Symptoms linked to discontinuation of PRISTIQ happen to be reported. Patients should be monitored for symptoms when discontinuing treatment. A gradual lowering of dose as an alternative to abrupt cessation is recommended
whenever you can. -- Dosage adjustment (50 mg every other day) is necessary in patients with
severe renal impairment or end-stage renal disease (ESRD). The dose
must not be escalated in patients with moderate or severe renal
impairment or ESRD. -- Products containing desvenlafaxine and products containing venlafaxine
shouldn't be used concomitantly with PRISTIQ. Negative effects
-- Essentially the most commonly observed complications in patients taking PRISTIQ
for MDD in short-term fixed-dose premarketing studies (incidence
over or add up to 5% and twice the incidence of placebo from the 50- or
100-mg dose groups) were nausea, dizziness, insomnia, hyperhidrosis,
constipation, somnolence, decreased appetite, anxiety, and specific
male sexual function disorders. Full prescribing information for PRISTIQ is going to be offered by Pristiq. com. Important Treatment Considerations for EFFEXOR XR
-- EFFEXOR XR is contraindicated in patients taking monoamine oxidase
inhibitors (MAOIs). -- Adult and pediatric patients taking antidepressants can experience
worsening in their depression and/or the emergence of suicidality. All
patients must be monitored appropriately and observed closely for
clinical worsening and suicidality, especially at the start of drug
therapy, or during increases or decreases in dose. Anxiety,
agitation, panic disorders, insomnia, irritability, hostility,
aggressiveness, impulsivity, akathisia, hypomania, and mania have already been
reported and could represent precursors to emerging suicidality. Stopping
or modifying therapy is highly recommended specifically when symptoms are
severe, abrupt in onset, you aren't section of presenting symptoms. -- Enhancing potentially life-threatening serotonin syndrome may
occur when EFFEXOR XR is coadministered for some other drugs that could
customize the serotonergic neurotransmitter systems lexapro online no prescription. Concomitant by using
EFFEXOR XR with MAOIs is contraindicated. If concomitant by using EFFEXOR
XR by having an SSRI, SNRI, or even a triptan is clinically warranted, careful
observation from the patient is advised. Concomitant using EFFEXOR XR
with tryptophan supplements isn't recommended. -- Treatment with venlafaxine is a member of sustained increases in
hypertension (BP) in many patients. Postmarketing cases of elevated
BP requiring immediate treatment are actually reported. Pre-existing
hypertension ought to be controlled. Regular BP monitoring is
recommended. -- SSRIs and SNRIs, including EFFEXOR XR, might increase the likelihood of
bleeding events. Concomitant using aspirin, NSAIDs, warfarin, and
other anticoagulants may add to this particular risk. -- Mydriasis has been reported in colaboration with venlafaxine; therefore,
patients with raised intraocular pressure or those at risk of acute
narrow-angle glaucoma (angle-closure glaucoma) really should be monitored. -- Abrupt discontinuation or dose reduction has become associated with
discontinuation symptoms. Patients needs to be counseled on possible
discontinuation symptoms and monitored while discontinuing the drug;
the dose really should be tapered gradually. -- The most typical adverse events reported in EFFEXOR XR short-term
placebo-controlled MDD, generalized anxiety disorder (GAD), social
panic attacks (SAD), and/or social anxiety disorder (PD) trials (incidence
greater than or add up to 10% and in excess of or add up to 2x that of
placebo) were anorexia, asthenia, constipation, dizziness, dry mouth,
ejaculation problems, impotence, insomnia, nausea, nervousness,
somnolence, and sweating. For full prescribing information for EFFEXOR XR, go to
www. EffexorXR. com. About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
elements of women's heath care treatment, infectious disease, gastrointestinal health,
nerves, inflammation, transplantation, hemophilia,
oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and
healthcare products companies. It's a leader within the discovery,
development, manufacturing and marketing of pharmaceuticals, vaccines,
biotechnology products and non-prescription medicines that improve
quality of life for anyone worldwide. Their major divisions include
Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal
Health. The statements on this press release which aren't historical facts are
forward-looking statements dependant on current expectations of future events
and therefore are subject to risks and uncertainties that might cause actual results
to differ materially from those expressed or implied by such statements. In
particular, there might be no assurance that PRISTIQ will be commercially
successful inside the highly competitive market for antidepressants inside the
U . s . , or that PRISTIQ will likely be approved sometime soon for other
indications (including treatment of vasomotor symptoms connected with
menopause) and/or abroad. Other risks and uncertainties include
the inherent uncertainty on the timing and success of, and expense
related to, research, development, regulatory approval and
commercialization of our own products and our pipeline products (including
future regulatory action regarding our other pending applications for
desvenlafaxine for the treatments for major depressive disorder plus the
treatment of vasomotor symptoms, concerning which no assurance might be given);
government cost-containment initiatives; restrictions on third-party
payments for your products; substantial competition inside our industry,
including from branded and generic products; data generated on our
products; the significance of strong performance from the principal products
and our anticipated awesome introductions; the highly regulated nature
of the business; product liability, intellectual property and other
litigation risks and environmental liabilities; uncertainty regarding our
intellectual property rights the ones of others; difficulties associated
with, and regulatory compliance with regards to, manufacturing in our
products; risks connected with our strategic relationships; economic
conditions including interest and forex rate fluctuations;
modifications in generally accepted accounting principles; trade buying patterns;
the impact of legislation and regulatory compliance; risks and
uncertainties related to global operations and sales; along with risks
and uncertainties, including those detailed from time to time in this
periodic reports filed using the Securities and Exchange Commission,
including our current reports on Form 8-K, quarterly reports on Form 10-Q
and annual set of Form 10-K, in particular the discussion under the
caption "Item 1A, RISK FACTORS. " The forward-looking statements in this particular
pr release are qualified by these risks. We assume no obligation
to publicly update any forward-looking statements, whether because of
new information, future developments you aren't.

SOURCE Wyeth Pharmaceuticals
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