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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