24th Aug 2011, 11:41 am by Olivia D'Orazio

United Therapeutics (NASDAQ:UTHR) announced Wednesday that its drug intended to treat patients suffering from pulmonary arterial hypertension (PAH) failed to meet the primary goal of a phase three study, causing its stock to plummet.

PAH is a disease characterized by increased blood pressure in the lungs, and is marked by a reduced tolerance for exercise. Common symptoms include dyspnea, fatigue, and fainting, among others.

The endpoint of the 16 week placebo-controlled study was based on patients’ six-minute walk distance – a test designed to determine how far a patient can walk in six minutes, and factors in conditions such as fatigue, dyspnea, or shortness of breath.

Mean walk distance was 333 metres at the start of the study, and by the end of the trial, the mean change was ten metres, for those in the United drug arm and the placebo group.

There was not enough of a difference between patients treated with United’s drug, and with the placebo, to determine definitive results, the company said.

United’s treprostinil diethanolamine drug is a sustained-release treatment and is administered orally to treat PAH by inducing the widening of arteries in the lungs and body.

The trial, a randomized, double-blind, placebo-controlled study, examined 310 patients currently treated for the disease. Each patient received either the treprostinil diethanolamine drug, or a placebo, twice daily.

“While we did not achieve a statistically significant result for this trial, we believe the positive results from our previously-announced FREEDOM-M study support an NDA filing of oral treprostinil in treatment naive patients,” said president and CEO, Roger Jeffs.

Indeed, the company’s previous phase 3 trial, called Freedom-M, showed that the mean change for the six-minute walk distance for those taking United’s drug was 23 metres.

“Given that treprostinil is already approved for use in PAH by subcutaneous, intravenous and inhaled routes of administration, we believe the data obtained from all FREEDOM trials support an NDA for oral treprostinil in this indication,” added Jeffs.

United said it is continuing further review and analysis of the preliminary results from the latest trial. the company still also plans to complete the new Drug Application (NDA) for the drug, to be filed in the first half of 2012.

The Silver Spring, Maryland-based company’s stock on the Nasdaq exchange plunged 17.45% as of 10:59 am EDT, to trade at $40.25 per share on Wednesday.

Posted on: Monday, 7 March 2011, 00:00 CST

As the allergy season gets underway, Dr. Michael R. Menachof, a board-certified otolaryngologist serving Denver, suggests allergy drops as a more comfortable alternative to traditional allergy shots.

Englewood, CO (PRWEB) March 5, 2011

with spring just around the corner, allergy season will be in full bloom in no time. Many people are already taking steps to prepare for the onset of their allergies. In preparation for the allergy season, Colorado allergy (advancedentdenver.com/allergy-testing-care.html) specialist Dr. Michael R. Menachof (advancedentdenver.com) is recommending allergy drops, a lesser-known therapy, for people who would rather avoid the discomfort of allergy shots.

"Allergy shots are a traditional method for treating allergies," explains Dr. Menachof. "However, not every person with allergies is a good candidate for shots. In such cases, I suggest patients consider allergy drops to reduce symptoms and desensitize them from their allergens."

Allergy drops, which are placed under the tongue, are similar to shots in the way they deliver slowly increasing amounts of antigens. known as immunotherapy, this treatment builds the body’s tolerance to allergens. because some patients cannot tolerate shots, Dr. Menachof uses drops as a safe and effective alternative.

"Allergy drops often prove more advantageous than traditional allergy shots for certain patients," says Dr. Menachof. "because drops require fewer clinic visits, they are less expensive and more convenient, as patients can take the drops daily at home. Drops provide an excellent alternative for my Colorado asthma (advancedentdenver.com/allergy-testing-care.html) and allergy patients. "

As an ear, nose and throat specialist, Dr. Menachof specializes in treating allergies but also offers services for patients who need help with snoring or fitting for hearing aids in Colorado (advancedentdenver.com/hearing-balance.html). In contrast to old-fashioned bulky hearing aids, new technological advances have resulted in small, almost invisible hearing devices that are both comfortable and discreet.

"due to my extensive training, my staff and I can help patients with balance problems, hearing issues, allergies, snoring, and sleep apnea," notes Dr. Menachof. "We offer a variety of treatment methods for these health and wellness concerns."

Michael R. Menachof, MD (advancedentdenver.com) received his Medical Doctorate degree from the University of California at San Francisco, consistently ranked as one of the top five medical schools in the country. He graduated in the top 5% of his class and was awarded placement in the prestigious Alpha Omega Alpha Medical Honor Society. Dr. Menachof remained at the University of California Hospitals to pursue his training in Head and Neck Surgery and Facial Plastic Surgery. He has served the Denver metro area from his practice, the Center for Aesthetic Facial Surgery, since 1992. He is board-certified by the American Board of Otolaryngology.

For the original version on PRWeb visit: prweb.com/releases/prweb2011/03/prweb5130304.htm

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My wife is concerned that she may have an ovarian cyst and would like the symptoms described to her so she can be ready for her dr.'s visit.

Painful menstruation is one symptom. They can do an internal ultrasound to determine this. I would not have them operate though, they may try to recommend this. I would look at herbal remedy's to heal this. also, alot of times they will just pop after a time (almost like a pimple) and go away.

very bad cramping that generates or pulsates. every woman gets one before her cycle but they sometimes bust. when they dont then the pain increases depending on the size. it is a very painful ordeal kinda like having a baby stuck on one side of you you may even be bent over to where it is hard to stand with one that hasnt bust. i agree with the writer above no operation they will eventually bust. i had two for the cyst one c section and one was with exploratory. not that it is evasive just unnecessary home remedies to soothe and bust the cyst are so much better depending on her tolerance of pain

Apart from tenderness in the side (over the ovary) you can also experience burning pain in the shoulder. This is called referred pain. You may also have abdominal swelling or bloating.

i would try get an apointment asap!!!
someone in my family has one…her tummy swelled slightly ad was very tender 2 touch.
tel her not 2 focus on the problem will only make her feel worse