Andy Health blog

Rexahn Pharmaceuticals, Inc. (AMEX:RNN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative treatments for cancer, central nervous system disorders, sexual dysfunction and other unmet medical needs, announced that the Company has initiated a Phase II clinical trial for its lead clinical compound ZoraxelTM, for the treatment of Erectile Dysfunction (ED). ZoraxelTM is being developed as an orally administered, on-demand-use tablet.
Zoraxel™ Phase II trial is a double-blind, placebo-controlled study. This multi-center trial is expected to be complete by the end of 2008.
Commenting on today’s news, Dr. Chang H. Ahn, Chairman and Chief Executive Officer of Rexahn, noted, "We are very pleased to announce the initiation of another Phase II trial. ZoraxelTM will prove itself a more effective, less toxic therapy for patients with erectile dysfunction."
About ZoraxelTM
ZoraxelTM is being developed as an immediate release tablet and has a well-established and excellent safety profile, different from current market leading PDE-5 inhibitors with many side effects (priapism, severe hypotension, myocardial infarction, sudden death, increased intraocular pressure and sudden hearing loss). Zoraxel™ is a dual neurotransmitter enhancer in the brain, and thus, acts through the central nervous system that regulates sexual functions, whereas the PDE-5 inhibitors work in the peripheral blood vessels and affect only erectile function. Buy propecia without prescription In the model studies, ZoraxelTM has been shown to significantly improve all three functions of sexual activity, i.e. sexual arousal, erection, and release. As such, ZoraxelTM may be a more effective ED treatment for patients who are both responsive and unresponsive to PDE-5 inhibitors.
About Erectile Dysfunction (ED)
ED is defined as the consistent inability to attain and maintain an erection sufficient for satisfactory sexual intercourse. It is estimated to affect up to 30 million men in the United States, with 52% of men between the ages of 40 and 70 reporting difficulty with erectile function. By the year 2025, it is estimated that 322 million men worldwide will suffer from some degree of sexual dysfunction. Clinical management of ED has progressed substantially in recent years. The advancement of phosphodiesterase-5 (PDE-5) inhibitor therapeutics quickly followed the scientific understanding of the nitric oxide (NO) signaling mechanism in erectile tissue. Adverse events affecting the vascular system have been a major concern with drugs that regulate that response. Investigations into the neurotransmission involved in penile erection, hormone actions involved in this response, and biochemical signal transduction processes within the erectile tissue, are indicative of significant areas of scientific pursuit.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals is a biopharmaceutical company leveraging its proprietary technology platform to discover, develop and commercialize innovative treatments for cancer, central nervous system disorders, sexual dysfunction and other unmet medical needs. Rexahn’s compounds are designed to uniquely treat various disease states while significantly minimizing side effects in order to allow patients to regain their quality of life. For Additional information about Rexahn visit
Safe Harbor
This press release contains statements (including projections and business trends) that are forward-looking statements. Rexahn’s actual results may differ materially from the anticipated results and expectations expressed in these forward-looking statements as a result of certain risks and uncertainties, including, Rexahn’s lack of profitability, its auditor’s going concern qualification and the need for additional capital to operate its business to develop its product candidates; the risk that Rexahn’s development efforts relating to its product candidates may not be successful; the possibility of being unable to obtain regulatory approval of Rexahn’s product candidates; the risk that the results of clinical trials may not be completed on time or support Rexahn’s claims; demand for and market acceptance of Rexahn’s drug candidates; Rexahn’s reliance on third party researchers and manufacturers to develop its product candidates; Rexahn’s ability to develop and obtain protection of its intellectual property; and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission. These forward-looking statements are made as of the date hereof; Rexahn assumes no obligation to update these forward-looking statements.
Rexahn Pharmaceuticals, Inc.
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The results of new research on blood pressure
announced today reveal that despite Irish people getting their blood
pressure checked, the majority of them do not know what their reading is
(1). The research was commissioned by Boehringer Ingelheim in advance of
Buy viagra without prescription World Hypertension Day 2008 this Saturday, 17th May. High blood pressure,
or ‘hypertension’, is a very common disorder in Ireland and is associated
with an increased risk of coronary artery disease, stroke, heart attack,
kidney failure, and death. Unfortunately, there are no symptoms of
hypertension and the only way it can be diagnosed is by having one’s blood
pressure measured at regular intervals. About half of Irish adults over 50
years of age have high blood pressure (2).
Over 80% of those surveyed claimed to have had a blood pressure measurement
in the last year, but only a quarter recall their results and of those,
only about half (i.e. 14%) can recall their measurement with any accuracy
(1). In relation to the appropriate blood pressure measurement for a
healthy adult, only 33% claim to know what the normal measurement should be
(1).
The normal level of blood pressure is usually about 120 (systolic) over 80
(diastolic), but this can vary with age, how a person feels and activity. A
person with blood pressure higher than 140 over 90 should be seen for
follow-up by their family doctor. Generally anyone over 30 years old should
have their blood pressure checked every two years, preferably by their
family doctor.
When asked to rate cardiovascular diseases in order of what would be most
frightening to them 50% surveyed said a stroke, 34% said a heart attack,
13% said heart failure, with only 2% saying high blood pressure (1).
"As high blood pressure is the most important risk factor in stroke, it is
a matter of concern that only 2% of people rate this as most frightening.
This finding indicates that there is a disconnect amongst people as to what
causes stroke. It is important to realise that, if left untreated, this
’silent killer’ as it is often called, can cause a stroke. Allowing it go
untreated can potentially lead to this life threatening condition, amongst
other conditions such as heart attack, heart failure and kidney disease,"
said Dr. John Cox, a General Practitioner in Fethard-on-Sea with an
interest in hypertension. "Fortunately, high blood pressure is easy to
diagnose and usually controllable with lifestyle modifications (diet,
exercise & weight reduction) and for some, medication where necessary. I
would advise people to ask their GP or healthcare provider to give them
their blood pressure reading at the time it is taken, and to keep a record
of it for future reference. The main message is, check your blood pressure
and know you reading."
When asked what time of day a person is most likely to have a
cardiovascular event, such as a heart attack or stroke, 80% of people
surveyed did not know that risk was greatest in the early morning hours
(1). The highest rise in blood pressure occurs in the early morning hours
(3), so for people with hypertension, the early morning hours pose the
largest risk (4, 5).
There is often no single cause of high blood pressure. A number of factors
can combine to raise blood pressure and high blood pressure tends to run in
families. Being overweight, having a high consumption of alcohol, poor
level of exercise, high stress levels and eating too much sodium (found in
salt) may lead to an increase in blood pressure. Blood pressure also
increases with age.
Another important finding was that 90% of those surveyed believe that in
most cases high blood pressure can be cured when treated. There is no cure
for high blood pressure, but it is controllable usually with lifestyle
modifications and medication if indicated. It was noted that there is a
general consensus over the broad descriptions of high blood pressure, with
96% agreeing that high blood pressure can lead to other problems such as
stroke, 93% agreeing that treating high blood pressure can reduce the
chance of a person having a heart attack or stroke and 86% believe high
blood pressure is often caused by poor diet and/or lack of exercise (1).
Of those surveyed about a third of adults (29%) aged 35+ have suffered high
blood pressure with the incidence most apparent among those aged 65+, in
the C2DE’s and those in the rest of Leinster, excluding Dublin (1).
Interestingly Dubliners recorded the lowest incidence of high blood
pressure, at 17% (1).
World Hypertension Day, initiated by the World Hypertension League in 2005,
was established to highlight the serious medical complications of
hypertension and to communicate to the public information on prevention,
detection and treatment. Each year, May 17th is designated World
Hypertension Day (6).
Research Methodology
This survey was conducted through Behaviour & Attitudes’ TeleBarometer
survey, which delivers a nationally representative sample of 1,000 adults
aged 15+. Quotas used reflect census distribution of population (gender,
age, class, region, etc). All interviewing was conducted via the telephone
in Behaviour & Attitudes’ in-house Computer Assisted Telephone Interviewing
(CATI) unit. Fieldwork was conducted between April 2nd - April 13th 2008.
The survey delivered a sample of 645 adults aged over 35. All interviewing
was conducted in accordance with the standards established for market
research by ESOMAR (Europe), MRS (UK) and Marketing Society (Ireland).
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates
globally with 135 affiliates in 47 countries and 39,800 employees. Since it
was founded in 1885, the family-owned company has been committed to
researching, developing, manufacturing and marketing novel products of high
therapeutic value for human and veterinary medicine.
In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while
spending one fifth of net sales in its largest business segment
Prescription Medicines on research and development.

References:
1. ‘Awareness of and Attitudes to Hypertension’, Behaviour and Attitudes
TeleBarometer Research, April 2008
2. About half of Irish adults over 50
years of age have high blood pressure
3. Neutel, JM, et al. Magnitude of the early morning blood pressure surge
in hypertensive patients- pooled analysis. Poster presented at the 20th
Annual Meeting of the American Society of Hypertension, San Francisco,
14-18 May 2005.
4. Shimada, K, et al. Blood Press. Monit 2001; 6: 349-353.
5. Elliot, WJ, et al. Am. J. Hypertens. 2001; 14: 291S-295S.
6. World
Hypertension Day
Boehringer Ingelheim
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Men’s Health News
Plans are in the pipeline to raise awareness of health issues which affect men in particular.
The Federal Health Minister Nicola Roxon says the government has set in motion plans for the development of Australia’s first health policy for men based on a draft document developed in 1996.
The Health Minister says a discussion paper followed by consultations across the country over the next 12 months, will raise awareness of preventable problems and specific health challenges which men need to deal with.
Ms Roxon says the resistance amongst men with regard to seeking treatment is an issue the government is determined to help men tackle.
The government’s national Men’s Health Policy aims to address the large diversity between the health of men and women.
The initiative has been given a kick start with a grant of $460,000 grant to the National Suicide Prevention Strategy and another $95,000 to encourage men to seek preventative health checks.
Buy generic acomplia The Men’s Health policy will aims to overcome the widespread resistance among men to seek treatment by making health services more male-friendly and to engage men in looking after their own health.
Research in recent years has revealed that not only do men on average die almost five years earlier than women, but they are also three times more likely to commit suicide and to die from HIV/AIDS, lung cancer, emphysema and liver diseases.
Ms Roxon says men’s health is an issue which is too often overlooked.
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Researchers have long known that type-2 diabetes and depression often go hand in hand. However, it’s been unclear which condition develops first in patients who end up with both. Now, a new study led by Johns Hopkins doctors suggests that this chicken-and-egg problem has a dual answer: Patients with depression have an increased risk of developing type-2 diabetes, and patients with type-2 diabetes have an increased risk of developing depression.
For the study, published in the June 18 Journal of the American Medical Association, diabetes expert Sherita Hill Golden, M.D., M.H.S., and her colleagues took advantage of data generated by the Multi-Ethnic Study of Atherosclerosis (MESA), which examined risk factors for atherosclerosis, or hardening of the arteries, in an ethnically diverse group of 6,814 men and women between ages 45 to 84. Participants in the MESA study identified themselves when they enrolled as white, black, Hispanic or Chinese.
During MESA, participants made three visits to clinics over the course of three years to be examined for various atherosclerosis risk factors, including type-2 diabetes and symptoms of depression, which could serve as a precursor for full-blown clinical depression.
The study also collected information on other atherosclerosis risk factors, such as participants’ body-mass indices, blood pressure, diet and exercise patterns, and smoking habits, as well as information correlated with health in general, such as income and socioeconomic factors.
Mining the data for their own purposes, Golden and her colleagues excluded from their analysis all participants who had high fasting glucose, an indication of diabetes, at the initial clinic visit. They then looked to see whether participants who initially had elevated symptoms of depression, as indicated through a questionnaire, were more likely than those who didn’t to develop high fasting glucose at the end of the three-year study period.
Results showed that those with elevated depressive symptoms were 42 percent more likely overall to develop diabetes by the end of the study than those without these symptoms. Moreover, the stronger the symptoms, the higher the risk of diabetes, a "dose response" that lends strength to the findings.
Even when the researchers accounted for such factors as overweight, lack of exercise, and smoking, the risk of developing diabetes was still 34 percent higher for patients with depressive symptoms.
To investigate whether diabetes could lead to depression, Golden and her colleagues used the same pool of MESA information and excluded those who had elevated depressive symptoms at the initial clinic visit. Then, they looked to see whether those who had high fasting glucose with or without a formal diagnosis of diabetes were more likely to develop depressive symptoms by the end of the study.
The researchers found that patients treated for diabetes, about 9 percent of the group, were about 54 percent more likely to develop elevated depressive symptoms than those without diabetes.
Surprisingly, those with prediabetes or untreated diabetes were about 25 percent less likely to develop elevated depressive symptoms than people with normal fasting glucose, a finding Golden’s team cannot explain at this time.
Golden, an associate professor of medicine and epidemiology at the Johns Hopkins University School of Medicine, speculates that depression may lead patients to develop behaviors that trigger diabetes or make it worse, such as overeating, not exercising or smoking. Similarly, keeping up with the often extensive treatment regimens to care for their diabetes may make patients’ depression worse. Understanding how one condition might lead to another could improve treatments for both problems, she says.
"Having both diabetes and depression can make it difficult for patients to get the good clinical outcomes that we like to see for each of these conditions," says Golden. "To make sure that patients with diabetes and depression receive the best care, we wanted to get to the bottom of the connection between these two conditions.
"It’s important that doctors be attuned to look for both conditions in patients at risk for either diabetes or depression," Golden adds. "We may want to develop interventions for both treatments, instead of just one or the other."
generic ultram online buy Other Hopkins researchers who participated in this study include Mariana Lazo, M.D.. M.Sc.; Hochang Benjamin Lee, M.D.; and Constantine Lyketsos, M.D., M.H.S.
The MESA study was supported by grants from the National Heart, Lung, and Blood Institute. Golden and her colleagues’ research was supported by a Patient-Oriented Mentored Scientist Award through the National Institute of Diabetes and Digestive and Kidney Diseases.
Johns Hopkins Medicine
901 S. Bond St., Ste 550
Baltimore, MD 21231
United States

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Eli Lilly and Co (NYSE:
LLY) and Boehringer Ingelheim announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMEA) has issued a positive opinion supporting the approval of Cymbalta(R)
(duloxetine hydrochloride) for the treatment of Generalised Anxiety
Disorder (GAD).
The positive opinion is based upon the results of five clinical studies
– four double-blind placebo-controlled studies and a relapse prevention
study — involving more than 2,000 non-depressed adults with GAD. In each
of the four placebo-controlled studies safety and efficacy were assessed.
Duloxetine significantly improved core anxiety symptoms (as measured by the
Hamilton Anxiety Scale), compared with placebo (p less than or equal to
0.001, p=0.02, p=0.007, p less than or equal to 0.001 respectively)
(1,2,3,4) and demonstrated improvement in role functioning, including
ability to perform everyday activities in work, home and in social
situations.(5,6) In addition, duloxetine significantly decreased the
likelihood of relapse in those patients who initially responded to
duloxetine and were maintained on treatment for six months compared with
those switched to placebo.(7) The most common side effects in these studies
included nausea, fatigue, dry mouth, drowsiness, constipation, insomnia,
decreased appetite, hyperhidrosis, decreased libido, vomiting, ejaculation
delay and erectile dysfunction.
Although global prevalence is not currently known, more than nine
million Europeans (8,9) and six million people in Central and South America
are estimated to suffer from GAD.(10) Difficult to detect, due to the fact
that the condition presents with a variety of symptoms,(11) GAD is
characterised by more than simple anxiety. The disorder is diagnosed when
patients suffer from excessive anxiety and worry about a number of events
and activities (such as performance at work or school) over a sustained
period of at least six months.(12)
"If left untreated, symptoms of Generalised Anxiety Disorder may
progress to prevent patients from working and operating in daily social
situations," said Dr. Christer Allgulander of the Department of Clinical
Neuroscience, Karolinska Institutet in Stockholm. "According to population
and primary care surveys the majority of people suffering from anxiety, and
their physicians, still have unmet needs. This positive opinion on
duloxetine creates another effective pharmacotherapy option that will help
patients feel better, and help physicians in their aim to improve
functioning for those suffering from this debilitating condition."
Duloxetine, a member of a class of drugs commonly referred to as
serotonin and noradrenaline reuptake inhibitors,(13) is already approved to
treat major depressive disorder and diabetic peripheral neuropathic pain.
Duloxetine gained marketing authorisation for the treatment of GAD in
Mexico in 2006 and in the United States in 2007.
About Generalised Anxiety Disorder
Approximately nine million Europeans (8,9) and six million people in
Central and South America are estimated to suffer from GAD.(10) Quality of
life is affected as symptoms of GAD can include exaggerated worry or
chronic anxiety, irritability and poor concentration. Ability to work is
often compromised with the manifestation of physical symptoms such as
muscle tension, fatigue, sleep disturbance and nausea.(12) The illness
tends to be chronic with periods of exacerbation and remission. Patients
report that episodes of generalized anxiety disorder are often brought on,
or worsened, by stressful life events.(14)
About Duloxetine
While duloxetine’s mechanism of action in humans is not fully known, it
is believed to affect both serotonin and norepinephrine/noradrenaline
mediated nerve signalling in the brain and the spinal cord. Based on
pre-clinical studies, duloxetine is a balanced and potent reuptake
inhibitor of serotonin and norepinephrine/noradrenaline. Scientists believe
its effect on pain perception is due to increasing the activity of
serotonin and norepinephrine in the central nervous system.
Duloxetine is approved for the treatment of depression and diabetic
peripheral neuropathic pain, in many countries and is approved in some
countries for the treatment of stress urinary incontinence, Major
Depressive Disorder and Generalized Anxiety Disorder. Duloxetine is
approved only for adults 18 and over. There is a possibility of an
increased risk of suicidal thoughts or behaviour in children and young
adults treated with antidepressants. Patients should call their doctor
right away if they experience worsening depression symptoms, unusual
changes in behaviour or thoughts of suicide, especially at the beginning of
treatment or after a change in dose.
Patients taking duloxetine may experience dizziness or fainting upon
standing. The most common side effects of duloxetine include:
– For depression: Nausea, dry mouth, headache, insomnia, diarrhea
– For diabetic peripheral neuropathic pain: Nausea, somnolence
(sleepiness), fatigue, headache, dizziness
– For stress urinary incontinence: Nausea, dry mouth, fatigue
– For Generalised Anxiety Disorder: Nausea, fatigue, dry mouth,
drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis,
decreased libido, vomiting, ejaculation delay and erectile dysfunction.
Duloxetine is contraindicated in patients who are allergic to it, who
have liver disease resulting in hepatic impairment, who are taking a
monoamine oxidase inhibitor (MAOI), fluvoxamine, ciprofloxacin or enoxacine
or who have severe kidney disease. The initiation of treatment with
duloxetine also is contraindicated in patients with uncontrolled
hypertension that could expose them to a potential risk of hypertensive
crisis.
Eli Lilly and Company and Boehringer Ingelheim
In November 2002, Eli Lilly and Company and Boehringer Ingelheim signed
a long-term agreement to jointly develop and commercialize duloxetine
hydrochloride. This partnership covers neuroscience indications in most
countries outside of the United States and Japan, with few exceptions.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of best-in-class pharmaceutical products by applying the latest
research from its own worldwide laboratories and from collaborations with
eminent scientific organizations. Headquartered in Indianapolis, Ind.,
Lilly provides answers - through medicines and information - for some of
the world’s most urgent medical needs. Additional information about Lilly
is available at
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates
globally with 135 affiliates in 47 countries and almost 38,900 employees.
Since it was founded in 1885, the family-owned company has been committed
to researching, developing, manufacturing and marketing novel products of
high therapeutic value for human and veterinary medicine. In 2007,
Boehringer Ingelheim posted net sales of 10.9 billion euro while spending
one fifth of net sales in its largest business segment Prescription
Generic ultram pills no prescription Medicines on research and development. For more information please visit

Duloxetine for major depressive episodes is marketed by Lilly and
Boehringer Ingelheim in all countries included in the partnership under the
brand name Cymbalta, except for Greece, Italy and Spain. In Greece, Italy
and Spain Lilly markets the product as Cymbalta and Boehringer Ingelheim
markets the product as Xeristar(R). In the United States, Cymbalta is
marketed by Lilly and Quintiles. In Japan, duloxetine will be co-developed
and co-marketed by Lilly and Shionogi & Co., Ltd.
Duloxetine for stress urinary incontinence is marketed by Lilly under
the brand name Yentreve.(R)
References
(1) Koponen, H., et al. Efficacy of Duloxetine for the Treatment of
Generalized Anxiety Disorder: Implications for Primary Care Physicians.
Prim Care Companion J Clin Psychiatry 2007: 9(2):100-107
(2) Rynn M., et al. Efficacy and Safety of Duloxetine in the Treatment
of Generalized Anxiety Disorder: A Flexible-Dose, Progressive-Titration,
Placebo- Controlled Trial. Depression and Anxiety 2007: 25(3): 182-189.
(3) Hartford, J., et al. Duloxetine as an SNRI Treatment for
Generalized Anxiety Disorder: Results from a Placebo- and Active-Controlled
Trial. Int Clin Psychopharmacol 2007: 22(3):167-74.
(4) Nicolini H, et al. Improvement of psychic and somatic symptoms in
adult patients with generalized anxiety disorder: Examination from a
duloxetine, venlafaxine extended-release, and placebo-controlled study. In
Press at Psychological Medicine.
(5) Endicott, J., et al. Duloxetine Treatment for Role Functioning
Improvement in Generalized Anxiety Disorder: Three Independent Studies. The
Journal of Clinical Psychiatry 2007: 68(4):518-24
(6) Allgulander, C., et al. Pharmacotherapy of Generalized Anxiety
Disorder: Results of Duloxetine Treatment from a Pooled Analysis of 3
Clinical Trials. Current Medical Research and Opinion 2007: 23(6):
1245-1252
(7) Davidson JRT, et al. Duloxetine treatment for relapse prevention in
adults with generalized anxiety disorder: A 26- week randomized
placebo-controlled study. Poster presented at the American College of
Neuropsychopharmacology annual conference 2007. Boca Raton, Florida
(8) Lieb, R, et al. The epidemiology of generalised anxiety disorder in
Europe. European Neuropsychopharmacology 2005 Aug;15(4):445-52.
(9) National Institute of Economic and Social Research. Summarized from
the National Institute Economic Review,194, 28 October 2005.
(10) Calculated extrapolations of prevalence rates against the
populations of a particular country or region, based upon prevalence of
generalized anxiety disorder in the US, UK, Canada or Australia. Available
at:
Accessed on 2.4.08
(11) Gliatto, M.F. Generalised Anxiety Disorder. American Family
Physicians, Vol. 62/No. 7, October 1, 2000.
(12) National Institute of Mental Health (NIMH). Anxiety Disorders.
Available at:
Accessed on 2.5.08
(13) Bymaster, FP et al. The Dual Transporter Inhibitor Duloxetine: A
Review of its Preclinical Pharmacology, Pharmacokinetic Profile, and
Clinical Results in Depression. Current Pharmaceutical Design. 2005; 11:
1475-1493.
(14) Patient.co.uk. Generalized anxiety disorder. Available at
Accessed on 2.5.08
Eli Lilly and Company

View drug information on Cymbalta.
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