Andy Health blog

United
Therapeutics Corporation (Nasdaq: UTHR) and its wholly-owned subsidiary,
Lung Rx, Inc., announced the submission of a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval
of an inhaled formulation of treprostinil (ITRE) for the treatment of
pulmonary arterial hypertension (PAH), a chronic, life-threatening disease.
The submission starts a 60-day period during which the FDA will examine the
application for completeness. If the FDA accepts the ITRE NDA for review,
then it is expected to be subject to the standard 10- to 12-month review
period before an action letter is issued.
"We believe that an inhaled formulation of treprostinil will be a very
desirable option for PAH patients," said Martine Rothblatt, Ph.D., United
Therapeutics’ Chairman and Chief Executive Officer. "The completion of the
NDA filing is a huge milestone in United Therapeutics’ quest to develop as
many formulations of treprostinil as possible to create better, more
convenient therapies to treat the debilitating effects of PAH along the
full spectrum of the disease."
The ITRE NDA is principally supported by data from the TRIUMPH-1 Phase
III clinical trial.
About TRIUMPH-1
TRIUMPH-1 (TReprostinil Sodium Inhalation Used in the Management of
Pulmonary Arterial Hypertension), was a randomized, double-blind, placebo-
controlled trial of patients with Generic levitra pills no prescription PAH. ITRE is prepared once per day and
administered in four daily inhalation sessions using the NEBU-TEC
Optineb(TM) ultrasonic nebulizer, with each inhalation session taking
approximately 1-2 minutes.
The TRIUMPH-1 clinical trial is one of the first pivotal trials to
assess the incremental benefit of an add-on therapy in PAH patients who are
already receiving an approved background therapy. The study population
consisted of 235 patients who were optimized on an approved oral therapy
for PAH, either bosentan (Tracleer(R)), an endothelin receptor antagonist,
or sildenafil (Revatio(R)), a phosphodiesterase-5 inhibitor. The majority
of patients were New York Heart Association (NYHA) Class III (~98%) of
varied etiologies, including idiopathic or familial PAH (~60%), collagen
vascular disease associated PAH (~30%), and PAH associated with HIV,
anorexigens or other associated conditions (~10%).
The primary efficacy endpoint of the TRIUMPH-1 clinical trial was the
change in six-minute walk (6MW) distance at 12 weeks measured at peak
exposure, defined by the trial protocol as 10-60 minutes after
administration of ITRE relative to baseline. Analysis of the TRIUMPH-1
clinical trial results confirmed an improvement in median 6MW distance of
approximately 20 meters (pBuy ultram pills | Buy lexapro without prescription | Buy generic acomplia

The Journal of Environmental and Occupational Medicine (JOEM) has published a series of new studies that suggest depression in the workplace may be a much bigger problem - with more serious social and economic impacts - than employers realize.
The peer-reviewed journal has devoted an entire special-edition, titled "Depression in the Workplace," to the topic, with 15 papers prepared by experts on depression and workplace health. The special issue presents a comprehensive update on workplace depression and calls for a new approach to managing the disorder.
Among the findings highlighted in the special issue:
- Workplace depression closely tracks depression in the general population. More than six percent of the employed population meets criteria for major depressive disorder. When people with bipolar disorder and other forms of depression are added, the true rate is even higher.
- Only about half of depressed workers receive any treatment, and less than half of these receive care that is consistent with current treatment guidelines for organizations such as the American Psychiatric Association.
- Because so few workers are treated for depression, workplace productivity is impacted significantly. Studies show increases in absenteeism and unemployment, as well as disruptive effects on work organization and increased health and disability costs.
- Depression tends to strike workers earlier than other chronic diseases and may affect productivity for a much longer period. Unlike conditions such as cardiovascular disease or hypertension, depression often strikes very early in a worker’s career, creating a disease burden that may last for decades in the workplace.
Buy generic lasix The latest JOEM findings follow a major JOEM study released last summer indicating that the costs of health conditions such as depression, sleep disorders and fatigue have not been fully measured by employers. Using new measurement tools, including employee self-assessment, the study showed that conditions such as depression can be more costly than health conditions that have traditionally been assumed to be an organization’s key cost-drivers - such as cardiovascular disease and hypertension.
The JOEM study suggested that when measurements of health costs take into account factors such as absenteeism and presenteeism, conditions such as depression may be costing employers up to four times more than they realize in lost productivity.
The American College of Occupational and Environmental Medicine, which publishes JOEM, presented the special issue as the latest offering in its Depression in the Workplace Project, which is striving to raise awareness of the problem. Project co-directors are Garson M. Caruso, MD; and T. Larry Myette, MD.
"We are now beginning to fully realize how great an impact depression has on workplace productivity," said Dr. Myette. "Unlike other chronic conditions such as cardiovascular disease, depression may strike at a much earlier age - often in one’s twenties - so workers may experience disability throughout their working careers."
The result, he said, is an ongoing drain on productivity as those dealing with depression experience recurring episodes of the disease. "The average person has depression ten years before it is diagnosed," Dr. Myette said. "Sometimes it is not until the third or fourth depressive episode that depression is finally recognized."
The result is that over time, depression may cost employers thousands of dollars in productivity losses per affected employee - losses that can be lowered or prevented through effective treatment strategies.
"What we are trying to establish through research, and one of the major points of the entire Depression in the Workplace project, is that businesses can achieve a positive return on investment when they create programs to intervene and treat depression at its early stages," Dr. Caruso said. "More and more studies are now making this connection."
Conditions such as depression are more responsive, more quickly, in the workplace than others (diabetes, heart disease, etc.); offering employers an opportunity for greater return on dollars invested in treatment than may be recognized.
Having defined the scope of the problem, the JOEM issue examines promising approaches to improving the management of workplace depression, including programs to improve coping skills, screening programs and the promotion of early treatment. The JOEM studies also suggest that while antidepressant medications are effective for some depressed workers, specific types of psychotherapy may be underused.
The JOEM issue also calls for a new, collaborative approach to depression that integrates the best features of clinical, community and workplace programs.
About ACOEM
ACOEM, an international society of 5,000 occupational physicians and other health care professionals, provides leadership to promote optimal health and safety of workers, workplaces, and environments.

About Journal of Occupational and Environmental Medicine
The Journal of Occupational and Environmental Medicine is the official publication of the American College of Occupational and Environmental Medicine. Edited to serve as a guide for physicians, nurses, and researchers, the clinically oriented research articles are an excellent source for new ideas, concepts, techniques, and procedures that can be readily applied in the industrial or commercial employment setting.
Journal of Occupational and Environmental Medicine
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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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