Andy Health blog

Forest Laboratories, Inc.
(NYSE: FRX) announced that study results show Lexapro (escitalopram
oxalate) significantly improved symptoms of depression as compared to
placebo treatment and was well tolerated in adolescents, aged 12-17, with
major depressive disorder (MDD), according to phase III data presented at
the 2008 Annual Meeting of the American Psychiatric Association. These
results suggest that Lexapro has potential as a useful treatment option for
adolescents with depression. Top-line results of this study were initially
released in November 2007.
"Treating depression in adolescents can be particularly challenging
because few antidepressants have demonstrated efficacy in clinical trials
in this population," said Graham Emslie, MD, Professor of Psychiatry at the
University of Texas Southwestern Medical Center in Dallas. "In this study,
Lexapro significantly improved depressive symptoms in adolescents with MDD,
and was also well tolerated by study participants."
Researchers estimate that up to eight percent of adolescents are
affected by depression. Depression is a chronic disease that requires
medical treatment. However, FDA-approved treatment options for this
population are limited. Lexapro is not currently approved by the FDA for
use in pediatric or adolescent patients.
Based on the results of this study, Forest plans to file for an
adolescent depression indication for Lexapro this year.
Study Results
A double-blind, parallel-group, placebo-controlled phase III study to
evaluate the safety and efficacy of Lexapro in the treatment of depressed
adolescents, aged 12-17, was conducted in multiple centers across the U.S.
A total of 316 patients entered the eight week study, receiving either
Lexapro 10-20 mg (n=158) or placebo (n=158). The primary endpoint was
change from baseline to Week 8 on the Children’s Depression Rating Scale -
Revised (CDRS-R) using last observation carried forward (LOCF) approach.
The CDRS-R is a commonly used clinician-rated instrument that covers 17
symptom areas of depression relevant to adolescents, including impaired
schoolwork, difficulty having fun, social withdrawal, physical complaints,
and low self-esteem. The study showed statistically significant improvement
in patients treated with Lexapro relative to placebo based on the change
from baseline in the Buy generic amoxil CDRS-R score (-22.1 for Lexapro vs. -18.8 for placebo
treatment; p=0.022).
The trial also showed that Lexapro was generally well-tolerated.
Discontinuation rates due to adverse events were 2.6 percent and 0.6
percent for patients receiving Lexapro and placebo, respectively. Serious
adverse events were reported by 2.6 percent of patients receiving Lexapro
and 1.3 percent for patients receiving placebo. The most commonly reported
adverse events (greater than 10 percent in either group) were headache (25
percent in Lexapro patients vs. 26 percent with placebo), menstrual cramps
(11 percent vs. 15 percent placebo), nausea (10 percent vs. 8 percent
placebo), insomnia (10 percent vs. 6 percent placebo) and inflicted injury
(9 percent vs. 13 percent placebo), the majority of which were accidental
in nature. The only adverse event occurring at a frequency of greater than
or equal to 5 percent and with an incidence for Lexapro treated patients
twice that of placebo treated patients was influenza-like symptoms (7
percent vs. 3 percent placebo).
Depression and Adolescents
Adolescent depression is characterized by persistent sadness and loss
of interest in usual activities. While the brain chemistry of depression is
not fully understood, research suggests that depression is caused by an
imbalance of certain chemicals in the brain, most notably serotonin.
Despite advances and progress in identifying and treating mental
disorders in adolescents, depression in this population remains
under-treated. Depression is a chronic disease that requires medical
attention and treatment, and if left untreated, may have serious
consequences. According to the National Alliance on Mental Illness (NAMI),
adolescents with untreated depression are likely to have ongoing problems
in school, at home and with their friends.
For adolescents who suffer from depression, psychotherapy,
cognitive-behavior therapy, interpersonal therapy and medication play an
important role in the management of their illness. Patients on
antidepressant treatment should also be closely monitored by healthcare
providers, family members and other caregivers.
About Lexapro
Lexapro is an SSRI being studied as a treatment for adolescents with
MDD. Lexapro is indicated for the initial and maintenance treatment of
major depressive disorder and generalized anxiety disorder (GAD) in adults.
Lexapro is thought to work by helping to restore the brain’s chemical
balance. It is believed to increase the availability of serotonin, a
substance in the brain believed to influence mood. In adults, Lexapro 10
mg/day is a well-tolerated therapy, with drop-out rates due to adverse
events comparable to placebo treatment in depression trials. Lexapro has
been prescribed to over 16 million people.
Important Lexapro Information
Depression and certain other psychiatric disorders are themselves
associated with increases in the risk of suicide. Antidepressants increased
the risk of suicidality (suicidal thinking and behavior) in children,
adolescents, and young adults in short-term studies of major depressive
disorder (MDD) and other psychiatric disorders. Anyone considering the use
of antidepressants in children, adolescents or young adults must balance
the risk to clinical need. Patients of all ages started on antidepressant
therapy should be closely monitored and observed for clinical worsening,
suicidality or unusual changes in behavior, especially at the beginning of
therapy or at the time of dose changes. This risk may persist until
significant remission occurs. Families and caregivers should be advised of
the need for close observation and communication with the prescriber.
Lexapro is not approved for use in pediatric patients.
Lexapro is contraindicated in patients taking monoamine oxidase
inhibitors (MAOIs), pimozide (see DRUG INTERACTIONS - Pimozide and Celexa),
or in patients with hypersensitivity to escitalopram oxalate. As with other
SSRIs, caution is indicated in the coadministration of tricyclic
antidepressants (TCAs) with Lexapro. SSRIs and SNRIs (including Lexapro)
and other psychotropic drugs that interfere with serotonin reuptake may
increase the risk of bleeding events. Concomitant use of aspirin, NSAIDs,
warfarin and other anticoagulants may add to the risk. Patients should be
cautioned about these risks. SSRIs and SNRIs have been associated with
clinically significant hyponatremia. Elderly patients or patients taking
antidiuretics or who are otherwise volume-depleted appear to be at a
greater risk. Discontinuation of Lexapro should be considered in patients
with symptomatic hyponatremia and appropriate medical intervention should
be instituted. The most common adverse events with Lexapro versus placebo
(approximately 5 percent or greater and approximately twice that of
placebo) were nausea, insomnia, ejaculation disorder, somnolence, increased
sweating, fatigue, decreased libido, and anorgasmia. Further information on
Lexapro is provided in the FDA approved Package Insert.
About Forest Laboratories and Its Products
Forest Laboratories is a US-based pharmaceutical company dedicated to
identifying, developing, and delivering products that make a positive
difference in people’s 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. product Azor(TM) (amlodipine and
olmesartan medoxomil), a calcium channel blocker and angiotensin receptor
blocker combination product indicated for the treatment of hypertension.
For more information, visit
Azor is a trademark of Daiichi Sankyo, Inc. and Campral is a
registered trademark of Merck Sante s.a.s., a 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 from time to time in
the Forest Laboratories’ Annual Report on Form 10-K, Quarterly Reports on
Form 10-Q, and any subsequent SEC filings.
Forest Laboratories, Inc.

View drug information on Azor; Campral; Lexapro.
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Auriga Laboratories, Inc. (OTCBB: ARGA), a specialty pharmaceutical company, announced today the launch of Extendryl® PEM and Extendryl® GCP. The two new products will be marketed under the Extendryl brand name which consists of prescription products to treat various cough, cold, and allergy symptoms.
The prescription respiratory market is valued at more than 8 billion dollars in sales and more than 68 million prescriptions are written annually in the US. Extendryl® PEM (phenylephrine HCl 30 mg; methscopolamine nitrate 1.25 mg) Tablets combine two compounds; a decongestant with an anticholinergic/drying agent in an extended release format to provide 8 to 12 hours of relief of symptoms for adults suffering from nasal congestion and mucosal drainage associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma. Extendryl® GCP Oral Solution combines three compounds (100 mg/5 mL guaifenesin; 15 mg/5mL carbetapentane citrate; 5 mg/mL hydrochloride), and is indicated for temporary relief of non-productive cough accompanying respiratory tract congestion associated with the common cold, influenza, sinusitis, and bronchitis.
Extendryl® PEM and Extendryl®GCP will be launched in March 2008. "These new products further solidify Auriga’s commitment to enhance the Extendryl product line, and the launch is well timed to coincide with the start of Spring allergy season. These new additions to the Extendryl family will be a highly synergistic addition to Auriga’s current promotional efforts," said Frank Greico, Chief Executive Officer of Auriga.
Extendryl is contraindicated in patients who are sensitive to any of the ingredients or related compounds, and in patients with glaucoma, hypertension, cardiac disease, hyperthyroidism, urinary retention, peptic ulcer, patients on MAO inhibitor therapy and during an asthmatic attack. Extendryl GCP is contraindicated in women who are pregnant and/or nursing. Extendryl PEM is contraindicated in children under 6 years of age. Buy generic amoxil See individual product package inserts for full prescribing information.
About Auriga Laboratories™
Auriga Laboratories is a specialty pharmaceutical company building an extensive product portfolio of prescription brands targeting high growth therapeutic categories in the respiratory, dermatology, and psychiatry markets, which have combined annual revenues of more than fifteen billion dollars in the United States. The company’s high-growth business model combines driving revenues through a primarily variable cost commission-based sales structure, acquisition of proven brand names, introduction of new brands, and a strategic development pipeline, all of which designed to enhance its growing direct relationships with physicians nationwide. Auriga’s exclusive prescription and over-the-counter product portfolio includes Aquoral™ for the treatment of Xerostomia, Akurza™, Xyralid™, Zytopic™, and Coraz™ dermatology products, and the Zinx™ Extendryl ®, and Levall ® Families of products for relief of symptoms associated with a range of acute respiratory diseases. For more information, visit
Forward-Looking Statements
The information contained herein includes forward-looking statements. These statements relate to future events or to the company’s future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause its actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the company’s current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to its operations, results of operations, growth strategy and liquidity.
The company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Statements regarding the company’s ability to increase its sales force and the success of such sales force in selling its products in light of competitive and other factors, the regulatory status and/or regulatory compliance of its products, the development of additional products, its ability to sustain market acceptance for its products, its dependence on collaborators, the company’s exposure to product liability claims, and the company’s prices, future revenues and income and cash flows and other statements that are not historical facts contain predictions, estimates and other forward-looking statements. Although the company believes that its expectations are based on reasonable assumptions, it can give no assurance that its goals will be achieved and these statements will prove to be accurate. Important factors could cause actual results to differ materially from those included in the forward-looking statements.
Auriga Laboratories
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Daiichi Sankyo, Inc.,
announced that data presented at the American Society of
Hypertension’s Twenty- Third Annual Scientific Meeting (ASH 2008) in New
Orleans demonstrated that the powerful combination drug AZOR(TM)
(amlodipine and olmesartan medoxomil) safely and effectively helped
patients across several major subpopulations lower their blood pressure
(BP). An analysis of patient subgroups from the pivotal registrational
trial demonstrated the efficacy of AZOR in several key difficult to treat
patient groups including people of African and Hispanic/Latino decent,
people with high body mass index (BMI) and those with diabetes.
The subgroup analyses were based on data from a pivotal, randomized,
double-blind, placebo-controlled factorial design study conducted in 1,940
pts with mild to severe hypertension (SeDBP) 95-120 mm Hg) to determine
if amlodipine (AML) 5-10mg/day plus olmesartan (OM) 10-40 mg/day for eight
weeks is more efficacious in reducing BP versus monotherapy components. The
groups were chosen because each population generally have either poor
control rates (Blacks and Hispanic/Latinos),(1)(2) are difficult to control
(people with high BMI)(3) or require lower blood pressure to achieve
control (those with diabetes).(4)
"As we know, hypertension affects many people from all walks of life,"
said Suzanne Oparil, M.D., Director, Vascular Biology & Hypertension
Program, University of Alabama at Birmingham, an investigator in the study
and President of ASH. "No two patients are alike, nor do any two people
present in the exact same way. This study has demonstrated that AZOR is an
important tool for physicians to consider when treating hypertensive
patients of different ethnicities and health characteristics, as well as
the more difficult to treat populations, such as people with diabetes."
Hypertension, also known as high blood pressure, affects approximately
72 million people in the United States and approximately one billion
worldwide.(5)(6) Called the "silent killer" because it often has no
specific symptoms, hypertension increases the risk of cardiovascular and
related diseases such as stroke, heart attack, heart failure and kidney
disease.(7) Of those diagnosed with high blood pressure, 64.9 percent do
not have the condition under control.(8)
ABOUT THE ANALYSES
RACE/ETHNICITY:
Blood pressure control in patients with hypertension remains
unsatisfactorily low in the US, particularly in Black and Hispanic/Latino
populations, with fewer than 30% of patients in these minority groups
treated to goal BP.(9)(10) Guidelines acknowledge that combination therapy
will be required for the majority of patients to attain BP goals, and
recommend that combination therapy utilizing agents from complimentary drug
classes should be considered when BP is difficult to control or there is
high cardiovascular risk, such as in minority patient
populations.(11)(12)(13)
Of the 1,940 patients who entered the eight week pivotal study, 1,459
were non-Black and 481 were Black. Further, ethnicity was asked separately
from race: 245 patients were Hispanic/Latino. All subgroups were matched
for baseline BP of 164/102 mm Hg. AZOR 10/40 mg demonstrated a 29/16 mm Hg
mean reduction in the Black cohort vs. 31/20 mm Hg in non-blacks. Further,
in the Hispanic/Latino study patient population, AZOR 10/40 mg demonstrated
a mean reduction of 29/21 mm Hg compared to 30/19 mm Hg in
non-Hispanic/non-Latino.
BMI:
A higher body mass index (BMI) often makes it more difficult for
patients with hypertension to achieve target BP.(14) The analysis of data
from the pivotal study demonstrated the ability of AZOR to produce
substantial reductions in BP compared to the monotherapy components,
regardless of BMI levels. For those patients with BMI greater than or equal
to 30 kg/m(2), AZOR 10/40 mg demonstrated mean reductions of 30/18 mm Hg
from an average baseline BP of 163/102 in the total cohort. Patients with
BMI of less than 30 kg/m(2) saw BP reductions of 31/21 mm Hg when treated
with Buy generic amoxil AZOR 10/40 mg from an average baseline BP of 165/101 in total cohort.
DIABETES:
Patients with hypertension and diabetes are at greater risk of
cardiovascular and renal disease and consequently have a more stringent
recommended target BP goal of Buy amoxil without prescription | Buy lexapro without prescription | Generic fosamax pills no prescription

For Health Professionals
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A hypertension medication called olmesartan medoxomil is effective in reversing the narrowing of the arteries that occurs in patients with high blood pressure, according to a new study.
Carlos M. Ferrario, M.D., one of the study’s lead investigators and director of the Hypertension and Vascular Research Center at Wake Forest University Baptist Medical Center, said, "We believe the data add to the growing evidence for the role of angiotensin receptor blockers in preventing or reversing vascular damage at many stages during this disease process."
The one-year study, titled Vascular Improvement with Olmesartan medoxomil Study (VIOS), was published in the current Journal of the American Society of Hypertension. The study evaluated the effects of an angiotensin receptor blocker (olmesartan medoxomil) vs. a beta-blocker (atenolol) on vascular function and structure in patients with stage 1 hypertension.
Olmesartan medoxomil is marketed in the United States as Benicar® and in Europe as Olmetec® by Daiichi Sankyo, Inc., which funded the study.
After one year of treatment, olmesartan medoxomil improved the artery abnormalities in high blood pressure patients and returned arterial architecture to normal levels. This was not seen with the atenolol.
Olmesartan medoxomil is a member of a class of antihypertensive medications that help lower blood pressure by blocking the angiotensin II receptor on the blood vessels that causes constriction and increase blood pressure. This medication also blocks the release of a hormone that causes salt retention and increased blood volume.
Hypertension affects one in three Americans and, if left uncontrolled for a long time, can cause organ damage, as well as heart disease, stroke and other problems.
Olmesartan is currently being reviewed in several trials, including the Randomized Olmesartan and Diabetes Microalbuminuria Prevention study (ROADMAP), which is investigating the drug’s effectiveness in preventing early stage kidney disease in 4,400 patients with type 2 diabetes.
The VIOS results were presented at the Hypertension 2008 symposium, a scientific conference co-hosted by the European and International Societies of Hypertension. Dr. Ferrario was in Berlin, Germany, for the symposium, where he conducted interviews with international media about the significance of the VIOS data.
Ferrario, professor of surgical sciences and of physiology and pharmacology, is the Dewitt Cordell Professor of Surgical Research at Wake Forest Baptist. His outstanding achievements in cardiovascular research include his breakthrough discoveries concerning the renin-angiotensin system and the use of novel antihypertensive medications for the prevention of heart attacks and strokes.
An internationally recognized center for the investigation of vascular disease and hypertension, the Hypertension & Vascular Research Center provides comprehensive care for hypertension and vascular disease, a mobile blood pressure clinic, early screening and management of peripheral artery disease.
Since it was established at Wake Forest, the Hypertension and Vascular Research Center has raised more than $23 million in funding from the National Institutes of Health and the American Heart Association. In addition, more than $3 million in grants have been awarded by pharmaceutical companies. The center has been awarded grant revenues totaling $4.7 million this academic year.
—————————-
Article adapted by Medical News Today from original press release.
—————————-
Wake Forest University Baptist Medical Center () is an academic health system comprised of North Carolina Baptist Hospital, Brenner Children’s Hospital, Wake Forest University Physicians, and Wake Forest University Health Sciences, which operates the university’s School of Medicine and Piedmont Triad Research Park. The system comprises 1,154 acute care, rehabilitation and long-term care beds and has been ranked as one of "America’s Best Hospitals" by U.S. generic propecia online buy News & World Report since 1993. Wake Forest Baptist is ranked 32nd in the nation by America’s Top Doctors for the number of its doctors considered best by their peers. The institution ranks in the top third in funding by the National Institutes of Health and fourth in the Southeast in revenues from its licensed intellectual property.
Source: Ann Hopkins
Wake Forest University Baptist Medical Center
View drug information on Benicar.
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