March 22, 2011 12:50 PM Eastern Daylight Time 

Phase III data presented at AAAAI builds upon Sunovion legacy in respiratory therapies

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion Pharmaceuticals inc. (Sunovion) today announced that data from a large scale, 671-patient, Phase III clinical study of ciclesonide nasal aerosol in a hydrofluoroalkane (HFA) formulation were presented in three separate scientific posters at the 2011 annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Francisco, California. the data show statistically significant improvements in reflective total ocular symptom score (rTOSS) in patients treated once daily with 74 µg of ciclesonide nasal aerosol as well as statistically significant improvements in nasal symptoms of seasonal allergic rhinitis (SAR) in patients treated once daily with both 74 µg and 148 µg of ciclesonide nasal aerosol. the overall incidence of adverse events (including epistaxis) was low and comparable to placebo. furthermore, the data also demonstrated statistically significant improvements with 74 µg of ciclesonide nasal aerosol in the overall rhinoconjunctivitis quality of life questionnaire (RQLQ) vs. placebo with a difference of 0.64.

“A Post-Hoc Analysis of Asthma Control and Lung Function following Treatment with Ciclesonide 80 ?g HFA-MDI twice Daily in Subjects with Mild-to-Moderate Persistent Asthma Previously Receiving low Dose Fluticasone Propionate/Salmeterol”

the delivery system in development is designed to dispense a small volume of the fine, dry mist of ciclesonide medication to a patient’s nose. This delivery system may be able to reduce some of the sensory effects such as back-of-the-throat run-off and run-out out of the nose that sometimes occur with aqueous-based corticosteroids for the treatment of allergic rhinitis.

“These findings indicate that ciclesonide HFA nasal aerosol may offer value for patients with seasonal allergic rhinitis including symptoms such as congestion, itchy / watery eyes and itchy nose,” said Charles P. Andrews, MD, of Diagnostics Research Group and a lead investigator of this ciclesonide HFA nasal aerosol clinical study. “We are encouraged by the results and look forward to continuing our efforts to develop treatment options for allergy sufferers.”

About the Phase III Ciclesonide HFA Nasal Aerosol (CIC-HFA) SAR Study

In this Phase III, placebo-controlled, double blind, parallel group study, 671 subjects, 12 years of age or older with SAR were randomized to either CIC-HFA 74 µg (N=226), 148 µg (N=225) or placebo (N=220), administered once-daily in the morning for two weeks during the Texas Mountain Cedar pollen season.

Efficacy was evaluated by subject-reported reflective and instantaneous total nasal symptom scores (rTNSS and iTNSS) assessing the individual nasal symptoms of nasal congestion, itching, sneezing, and runny nose. Efficacy was also evaluated by subject-reported reflective and instantaneous total ocular symptom scores (rTOSS and iTOSS) assessing the individual ocular symptoms of tearing, itchy and red eyes.

furthermore, this study measured the improvement in rhinoconjunctivitis related quality of life by administering a rhinoconjunctivitis quality of life questionnaire with standardized activities (RQLQ[S]).

Results from the Ciclesonide HFA Nasal Aerosol (CIC-HFA) SAR Study Poster Presentations:

• A Study Evaluating the Efficacy and Safety of Ciclesonide Hydrofluoroalkane Nasal Aerosol in the Relief of Nasal Symptoms of Seasonal Allergic RhinitisBoth CIC-HFA 74 µg and 148 µg demonstrated a statistically significant improvement in rTNSS (P<0.0001 for both), iTNSS (P<0.001 for both) and improvements in the individual nasal symptoms of congestion, nasal itching, sneezing and runny nose.the incidence of adverse events (including epistaxis) reported from this study for both doses of CIC-HFA were low and comparable to placebo.

• An Evaluation of the Effect of Ciclesonide Hydrofluoroalkane Nasal Aerosol on the Ocular Symptoms of Seasonal Allergic RhinitisCIC-HFA 74 µg demonstrated a statistically significant improvement in rTOSS (P=0.0124) and CIC-HFA 74 µg (P<0.05) and 148 µg (P<0.05) demonstrated improvement in iTOSS and individual ocular symptoms associated with SAR.

• Results of the Rhinoconjunctivitis Related Quality of Life Questionnaire Administered to Subjects with Seasonal Allergic Rhinitis following Treatment with Ciclesonide Hydrofluoroalkane Nasal AerosolBoth CIC-HFA 74 µg (P<0.0124) and 148 µg (P-value not determined) demonstrated improvements in the overall RQLQ[S].

In addition to the ciclesonide HFA nasal aerosol data presented at AAAAI, Sunovion also presented a poster titled, “A Post-Hoc Analysis of Asthma Control and Lung Function following Treatment with Ciclesonide 80 ?g HFA-MDI twice Daily in Subjects with Mild-to-Moderate Persistent Asthma Previously Receiving low Dose Fluticasone Propionate/Salmeterol” on data pertaining to the inhaled corticosteroid (ICS) asthma therapy, ALVESCO® (ciclesonide HFA inhalation aerosol). the data indicated that ALVESCO monotherapy maintained pulmonary function as measured by FEV1 in patients with mild-to-moderate persistent asthma, who were previously treated with combination low dose ICS and Long Acting Beta Agonist (LABA) therapy.1

About Allergic Rhinitis

Allergic rhinitis, which is commonly referred to as hay fever, is a collection of symptoms, predominantly in the nose and eyes, to allergens such as dust, dander and pollen. the sensitized immune system produces antibodies to these allergens, which cause chemicals called histamines to be released into the bloodstream, causing itching, swelling of affected tissues, mucus production, hives, rashes and other symptoms. Symptoms vary in severity from person to person.2

Allergic rhinitis is estimated to affect approximately 60 million people in the United States. Specifically, it is estimated that between 10% and 30% of adults and as many as 40% of children are affected by the disease. Approximately 12 million physician office visits each year are attributed to allergic rhinitis.3

SAR, which is also often referred to as hay fever, is caused by an allergy to the pollen of trees, grasses, weeds or mold spores. Depending on the allergen, the section of the country and the pollination periods, SAR may occur in the spring, summer or fall and may last until the first frost.

some people have symptoms of rhinitis no matter what the season. This is referred to as perennial allergic rhinitis, and it can be caused by allergens such as animal dander, indoor mold, dust mites and cockroaches.4

About Sunovion Pharmaceuticals inc. (Sunovion)

Sunovion is a leading pharmaceutical company dedicated to discovering, developing and commercializing therapeutic products that advance the science of medicine in the central nervous system (CNS) and respiratory disease areas and improve the lives of patients and their families. Sunovion’s drug development program, together with its corporate development and licensing efforts, has yielded a portfolio of pharmaceutical products including LATUDA® brand lurasidone HCl, LUNESTA® brand eszopiclone, XOPENEX® brand levalbuterol HCI Inhalation Solution, XOPENEX HFA® brand levalbuterol tartrate inhalation aerosol, BROVANA® brand arformoterol tartrate inhalation solution, OMNARIS® brand ciclesonide nasal spray and ALVESCO® brand ciclesonide HFA inhalation aerosol.

Sunovion, an indirect, wholly-owned subsidiary of Dainippon Sumitomo Pharma co., ltd., is headquartered in Marlborough, Mass. More information about Sunovion Pharmaceuticals inc. is available at sunovion.com.

About Dainippon Sumitomo Pharma co., ltd. (DSP)

DSP is a multi-billion dollar, top-ten listed pharmaceutical company in Japan with a diverse portfolio of pharmaceutical, animal health and food and specialty products. DSP aims to produce innovative pharmaceutical products in the CNS field, which has been designated as the key therapeutic area and will also focus in on other specialty disease categories with significant unmet medical needs, which are designated as frontier therapeutic areas. DSP is based on the merger in 2005 between Dainippon Pharmaceutical co., ltd., and Sumitomo Pharmaceuticals co., ltd. Today, DSP has more than 7,000 employees worldwide. Additional information about DSP is available through its corporate website at ds-pharma.com.

1 Meltzer EO, Korenblat PE, Weinstein SF, et al. Efficacy and safety evaluation of ciclesonide in mild-to moderate persistent asthma previously treated with inhaled corticosteroids. Allergy Asthma Proc 30:293-303, 2009.

2 Medline plus, a service of the U.S. National Library of Medicine and the National Institutes of Health. [Internet]. Available from nlm.nih.gov/medlineplus/ency/imagepages/19319.htm. Accessed: February 25, 2011.

3 American Academy of Allergy, Asthma and Immunology (AAAAI). [Internet]. Available from http:/aaaai.org/media/statistics/allergy-statistics.asp. Accessed: February 25, 2011.

4 American Academy of Allergy, Asthma and Immunology (AAAAI). [Internet]. Available from aaaai.org/patients/gallery/rhinitissinusitis.asp. Accessed: February 25, 2011.

LATUDA is a registered trademark of Dainippon Sumitomo Pharma co., ltd. LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks of Sunovion Pharmaceuticals inc. OMNARIS and ALVESCO are registered trademarks of Nycomed GmbH.

For a copy of this release or any recent release,visit Sunovion’s web site at sunovion.com

Berries may offer sweet hope in reducing the risk of Parkinson’sdisease, Harvard researchers are reporting.

The Harvard School of Public Health examined the effect onParkinson’s disease of flavonoids, a dietary component found incitrus fruits, chocolate and berries. The study was released lastSunday, and will be presented at the American Academy ofNeurology’s 63rd Annual Meeting in Honolulu in April.

The exact reason people develop Parkinson’s is not clear, thoughsome genetic and environmental factors are thought to beresponsible.

“The study opens up a whole area of potential future studiesexamining other types of environmental effects on Parkinson’s,”said Dr. Anna Hohler, a neurologist and professor of neurology atBoston University who was not involved with the study.

The study found that the top 20 percent of males who consumedthe most flavonoids were 40 percent less likely to developParkinson’s than the bottom 20 percent of men who consumed theleast amount of flavonoids. In women, there was no correlationbetween overall flavonoid consumption and Parkinson’s.

However, a subclass of flavonoid called anthocyanins, which areprimarily found in berries, were associated with reduced risk ofdeveloping Parkinson’s, said study author Dr. Xiang Gao, researchscientist at Harvard.

“These components we found to have neuroprotective effects,” hesaid. “Anthocyanins are a kind of pigment in food. for example, ina blackberry or a strawberry, when you see the different colors inthese berries, that’s because of anthocyanin.”

The study examined 129,617 individuals – 49,281 men and 80,336women. Participants were followed for 20 to 22 years, and wereasked to periodically fill out questionnaires about their foodconsumption habits. During that period, 805 participants developedParkinson’s. when the study started, the average age of maleparticipants was about 55, and the average age of femaleparticipants was about 51, Gao said.

Parkinson’s is a neurodegenerative disorder that affectsmovement. Most people with the disease start to get symptoms intheir sixties, though some people get it much earlier, Hohlersaid.

An estimated 60,000 Americans are diagnosed with Parkinson’sdisease each year, and as many as one million Americans live withParkinson’s, according to the Parkinson’s Disease Foundation in NewYork.

The study did not track the consumption of all types of berries,but looked specifically at strawberries and blueberries.

“We asked about a number of different dietary items – howfrequently they were eaten and the intake per month of each item,”Gao said. “That means we could only list the most consumedfoods.”

Participant’s questionnaires were then stored in a databasewhere researchers could later revisit answers and calculateaverages.

A strength of the study is the fact that people’s eating habitswere tracked before any of them had Parkinson’s, Gao said.

“Otherwise, if you do a kind of study called a case-controlstudy, in which you start with a group of people who already haveParkinson’s disease and ask them to recall their dietary intakefive years later, there may be some error,” he said. “This way wereduce this kind of memory bias.”

Gao said the link between flavonoid consumption on Parkinson’sand gender could not be confirmed until further studies takeplace.

“Our study is the first prospective study in humans,” he said.”So our observations need to be confirmed by other studies to seeif there is a difference. and if the other studies find some sortof gender, the next step is to do some more studies to understandthe mechanism.”

The study raises further questions about the consumption ofanthocyanin as well.

“Future research needs to find out in terms of quantity, howmuch do you need to consume to have a beneficial effect and in whatperiod of time,” Hohler said.

Although Gao agreed that more research must be done before anystrong conclusions are made, he said there is certainly no harm ineating more berries.

“Although it’s too early to recommend eating berries to reduceParkinson’s risk, think about the other beneficial effects ofberries,” he said. “If you only eat one cup of berries a month,maybe you can increase to another one.”

Hohler plans to discuss the study with Parkinson’s patients.

“When a study comes out like this, we say, ‘There is one studyso far which is interesting and may suggest that this might besomewhat neuroprotective,’ but that further studies need to be doneto clarify,” she said. “Parkinson’s patients are very eager to trythings that might decrease their chance of developing [thedisease].”

How to reduce stress and suspicion when seeking chronic pain medications.

You’re a chronic pain patient who takes several prescription narcotics to control your symptoms. Then one weekend, excruciating pain lands you in the emergency room. there, a doctor grills you about your medications, in part to make sure that you’re a legitimate pain patient, not someone seeking drugs. What can you do to help the ER doctor to believe you?

It’s not always easy to tell chronic pain patients from drug-seeking patients, says Howard Blumstein, MD, FAAEM, president of the American Academy of Emergency Medicine and medical director of the North Carolina Baptist Hospital emergency room.

Patients with chronic pain visit the ER for various complaints, he says. “Some of these patients have demonstrable disease, like sickle cell disease or chronic pancreatitis. I think that physicians are more likely to give them the benefit of the doubt when they come in and say they have pain.”

“Other patients are prone to have problems that you can never objectively demonstrate, like chronic back pain and chronic headaches,” he says. “We just have to take their word for it. You can’t look into anything and tell whether or not they’re actually having pain.”

Regardless of which group patients fall into, Blumstein says, “there are some patients who, because of their behavior or their frequent visits, still get labeled as being addicted to drugs or abusing drugs.”

What type of behavior raises suspicions? “Patients will come in and be very demanding, get into fights with doctors and nurses because they don’t think they’re getting enough pain medicine, and that causes the health-care providers to become suspicious of the patient’s motives,” he says. or the patient may ask for a specific narcotic like Demerol, or say they’re allergic to non-narcotic pain relievers.

Understanding Suspicion in the Emergency Room

“In most cases, it’s probably unfair to the patient,” Blumstein says. but emergency room doctors have strong motivations to carefully screen out drug seekers. they want to thwart drug abuse and any chance that narcotics will be diverted, for example, sold to strangers, or exchanged for illegal substances. “They have a high street value,” Blumstein says.

ER doctors have one useful tool, though. Currently, 34 states have prescription drug monitoring programs that allow doctors to check a patient’s prescription history online. “I can look up a patient and see all the prescriptions that have been filled for controlled substances,” says Blumstein, who practices in North Carolina. Doctors can use the database to corroborate a patient’s story. or they might see patterns that warn them to probe further for drug abuse, for example, prescriptions from numerous physicians that have been filled at multiple pharmacies.

“It is an unbelievably great tool for physicians,” says Eduardo Fraifeld, MD, president of the American Academy of Pain Medicine.

By Fred Cicetti Published: 2:00 AM – 02/09/11

Q. I’m a healthy 71-year-old woman, and I sweat a lot. I was wondering if it’s something I should discuss with my doctor.

A. Heavy sweating, or perspiration, is normal if you are exercising, are in a hot environment or are nervous. it also happens during menopause.

Healthy people sweat, but the amount varies widely. Some people inherit heavy sweating, especially on their palms and the soles of their feet. according to the American Academy of Dermatology, excessive sweating affects about 8 million Americans.

Hyperhidrosis — or sweating too much — can be caused by a health disorder related to your thyroid gland, nervous system or blood sugar.

You should go to a doctor if, suddenly, you begin to sweat much more (or less) than usual. other symptoms that should prompt a doctor visit are a change in body odor, the onset of night sweats for no obvious reason and sweating that disrupts your life.

Perspiration is the body’s cooling process. Glands in your skin produce sweat, which is a clear, salty liquid. most people have several million sweat glands distributed over their bodies. Sweat cools your body as it evaporates. when sweat mixes with bacteria on your skin, it can produce an unpleasant smell. Sweat, itself, is odorless.

If heavy sweating and body odor are problems for you, try over-the-counter antiperspirants and deodorants. If these products don’t work for you, your doctor may prescribe aluminum chloride.

In 2004, the U.S. Food and Drug Administration approved Botox (botulinum toxin type A), a drug that erases wrinkles, to treat severe underarm sweating that cannot be managed by topical agents. Botox is injected into the armpit, temporarily paralyzing the nerves in the underarm that stimulate sweat production.

There has been an e-mail circulating on the Internet that links antiperspirants to breast cancer. the National Cancer Institute, the FDA and the American Cancer Society say that no existing scientific or medical evidence links the use of underarm antiperspirants or deodorants to the development of breast cancer.

Some believe that the myth could have been started by women who were told not to wear antiperspirants or deodorants before a mammogram. the instructions were intended to prevent residue from these products showing up in X-rays and being mistaken for an abnormality in the breast.

Here are some tips to deal with sweating and body odor:

– Don’t eat malodorous foods such as garlic. — cut back on caffeine, which can stimulate sweating.– Natural fabrics, such as cotton, leather and wool, let your skin breathe. Wear clothing made of these fabrics to permit perspiration to evaporate.– use foot powders to absorb sweat. — Change shoes and socks often.– Remove your shoes occasionally during the day to allow your feet to dry.– Because stress can produce perspiration, you should try meditation or other relaxation techniques to relieve your tension.– Shower or bathe more often to eliminate bacteria.

Fred Cicetti is a freelance health-care writer from Sussex County, N.J. If you have a question, send an e-mail to .

Ads by Google

(ARA) – Any parent who’s sat up through the night with a sick child knows relieving their symptoms is only part of your mission. Easing the discomforts of cold and flu for your little one is a No. 1 priority. “Watching your child suffer, even if it’s from something as minor as a nose that’s sore and chapped from repeated blowing, is a terrible feeling for any parent,” says Dr. Tanya Remer Altman, a mother and pediatrician who is a best-selling author and spokesperson for the American Academy of Pediatrics. “Relieving the discomforts related to cold and flu not only helps kids feel better, it also reduces stresses for their parents.”"Dr. Tanya,” as she’s known to her patients and the millions who’ve seen her on the Today show or who follow her blog, offers some tips to help parents make children feel more comfortable while fighting a cold or the flu:* Flu vaccines are recommended for everyone 6 months and older, but it’s not unusual for children to fear a shot. ask your pediatrician about giving your child the flu vaccine in a nasal spray form. It’s available for children 2 and older, and provides the same protection and safety as the traditional flu shot. * Your mother probably swore by chicken soup and she was on to something. Serving sick children chicken soup not only gives them the benefit of nourishment while their bodies are fighting a virus, studies show chicken soup has anti-inflammatory properties as well. plus, it’s a popular comfort food that most kids love.* Sore, chapped noses add to the discomfort of having a cold. Tissues with added lotion, like Puffs plus with Lotion, can help prevent chapping from frequent nose blowing and wiping. the strong, lotion-filled tissues can help children get more out of their nose blowing, ensuring they’re confident they can blow without getting anything “icky” on their little hands. You can also use petroleum jelly or unscented ointment to soothe the irritation and discomfort.* another way to help relieve a stuffy nose is to try a few drops of nasal saline and gentle suctioning. A cool mist humidifier and a liberal application of Vicks on children older than 2 can also help, especially at night when lying down can make a child feel stuffy. Remember, however, never to use Vicks on children younger than 2 years old; it may actually increase the mucus in their airways.* Frequent hand-washing is important to prevent the spread of viruses. Yet washing your hands a lot, especially in cold weather, can leave them dry, sore and cracked. Teach your children to wash their hands while singing “Wash, wash, wash your hands, wash them every day. Wash them with water and wash them with soap to wash the germs away” to the tune of “Row, row, row your boat.” then follow up with a soothing lotion. You can find many fragrance-free varieties specially formulated for children.* when your child’s throat is sore, he might be unwilling to eat or drink much. Offer a sugar-free fruit Popsicle instead. the coolness can help ease a sore throat, your child will get some hydration from the frozen juice and he’ll feel like he’s getting a special treat.* Make trips to the doctor’s office fun by bringing a book or toy to keep your child occupied, and a snack in case she gets hungry. A special reward or treat after the visit is also a nice tradition. Finally, don’t overlook your own mental comfort as well; call the doctor if you feel your child’s symptoms are worrisome. “Parents often tell me they thought about calling, but didn’t want to be a bother,” Dr. Tanya says. “Most pediatricians are parents too, and they would rather take a few minutes to reassure you that your child’s cold symptoms will improve on their own than to not have you call about your sick child who really needs to be seen. Your pediatrician is there to help you, so if you feel something is important, pick up the phone and call.”

The views expressed here are those from a third-party content provider, and not necessarily the views or recommendations of the Lexington Clipper-Herald.