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Digestive Care, Inc. Announces FDA Approval of Pertzye (pancrelipase) Delayed-Release Capsules

Posted 9 days ago by Drugs.com

BETHLEHEM, Pa., May 18, 2012 /PRNewswire/ – Digestive Care, Inc. (DCI), announced that the company has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Pertzye, indicated for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. Pertzye is a unique pancreatic enzyme product containing bicarbonate-buffered enteric-coated microspheres and is protected by several U.S. and international patents. The Pertzye formulation was previously marketed by DCI for over a decade under the trade name Pancrecarb MS-16. Dr. Tibor Sipos, President and Chief Scientific Officer at DCI stated, "The approval of Pertzye represents a significant milestone for DCI. This achievement confirms our commitment to the continued development of products vital to the well-being of patients living with chronic diseases." T ... Read more

Should Cystic Fibrosis Patients Get So Many Antibiotics?

Posted 26 Mar 2012 by Drugs.com

MONDAY, March 26 – Antibiotics can prolong cystic fibrosis patients' lives, but the drugs also help treatment-resistant bacteria thrive in their lungs, a new, small study suggests. The findings from the 10-year investigation suggest, but do not prove, that the current standard of aggressive antibiotic treatment for cystic fibrosis patients may not always be the best approach. It's common to use antibiotics to control infection in cystic fibrosis patients' lungs, but maintaining a more diverse range of bacteria in the lungs may help some patients stay healthy longer, according to study senior author Dr. John LiPuma, a research professor of pediatrics and communicable diseases at the University of Michigan Medical School in Ann Arbor. "The conventional wisdom has been that as patients with cystic fibrosis age and become sicker, as their lung disease progresses, more and more bacteria ... Read more

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FDA Approves Kalydeco to Treat Rare Form of Cystic Fibrosis

Posted 31 Jan 2012 by Drugs.com

TUESDAY, January 31, 2012 – The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene. CF is a serious genetic disorder affecting the lungs and other organs that ultimately leads to an early death. It is caused by mutations (defects) in a gene that encodes for a protein called CFTR that regulates ion (such as chloride) and water transport in the body. The defect in chloride and water transport results in the formation of thick mucus that builds up in the lungs, digestive tract and other parts of the body leading to severe respiratory and digestive problems, as well as other complications such as infections and diabetes. CF, which affects about 30,000 people in the United States, is ... Read more

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New Drug Targets Underlying Cause of Cystic Fibrosis

Posted 2 Nov 2011 by Drugs.com

WEDNESDAY, Nov. 2 – A new drug that targets a faulty protein that causes cystic fibrosis led to improved lung function and fewer symptoms in people with the lung disease, researchers report. The drug – ivacaftor – is the first to halt the underlying processes that cause the inherited disease, which causes thick, sticky mucus to build up in the lungs and the pancreas and can lead to life-threatening infections, experts said. "It has a huge significance for the whole cystic fibrosis community," said study author Dr. Bonnie Ramsey, director of the Center for Clinical and Translational Research at Seattle Children's Hospital and a professor at the University of Washington School of Medicine. "It's the first time we have developed a therapy directed at the abnormal proteins and showing that it can be corrected." Only 4 percent to 5 percent of cystic fibrosis patients have the particular ... Read more

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Smoking's Effect on Lungs Similar to Cystic Fibrosis: Study

Posted 24 Oct 2011 by Drugs.com

TUESDAY, Oct. 18 – Smoking seems to have a similar effect on the lungs as cystic fibrosis, a life-threatening genetic disease affecting the lungs and other organs, a new study reveals. Researchers found that like cystic fibrosis, smoking leads to the production of sticky mucus that causes dry cough and infections. They concluded that cystic fibrosis treatments could potentially be used to treat smoking-related diseases – and vice versa. Cystic fibrosis interferes with the movement of salt and water in the cells lining the lungs, trapping bacteria in thick mucus, resulting in potentially fatal infections. The researchers said that smoking has a similar effect, resulting in mucus that causes several health problems, including dry cough, chronic bronchitis and chronic obstructive pulmonary disease. "We hope this study will highlight the importance of airway hydration in terms of lung ... Read more

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Tool to Spot Lung Infections in Cystic Fibrosis Patients Called Not Worth It

Posted 13 Jul 2011 by Drugs.com

TUESDAY, July 12 – Using an invasive procedure to diagnosis lung infections in infants with cystic fibrosis does not improve their long-term outcomes, a new study finds. Lung infections in children with cystic fibrosis are associated with increased risk of illness and death. Australian researchers examined the use of bronchoalveolar lavage (BAL), an alternative diagnostic procedure used when young children with CF can't provide sputum for analysis. BAL involves inserting a bronchoscope through the nose or mouth to collect a sample of fluid from the lungs. The study found that the 79 infants with CF who were treated for infection based on a diagnosis using BAL did not have a lower rate of lung-damaging infection or structural lung injury by the time they were 5 years old, compared with the 76 infants with CF who were diagnosed with lung infections using the standard procedure. The study ... Read more

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Genes Tied to Severity of Cystic Fibrosis Identified

Posted 23 May 2011 by Drugs.com

SUNDAY, May 22 – The severity of cystic fibrosis, a life-threatening hereditary condition that affects the lungs and digestive system, seems to be influenced by genetic variations, researchers have found. "Most cystic fibrosis patients born today live to their mid-30s, but that's an average. Some succumb to the disease before their 10th birthday, while others live into their 50s and we wanted to know why," Dr. Garry Cutting, a professor of pediatrics and member of the McKusick-Nathans Institute for Genetic Medicine at Johns Hopkins, said in a Hopkins news release. The study, published online in Nature Genetics, used DNA from 3,467 patients – including unrelated patients from the Genetic Modifier Study out of the University of North Carolina at Chapel Hill, the Canadian Consortium for Genetic Studies out of the University of Toronto, and related patients and their parents from the CF ... Read more

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Everyday Exercise Can Help Kids With Cystic Fibrosis: Study

Posted 6 May 2011 by Drugs.com

FRIDAY, May 6 – Simple exercise routines can improve lung function and overall fitness in children and teens with cystic fibrosis, the results of a small new study suggest. Cystic fibrosis, or CF, is a genetic disorder that causes a buildup of thick mucus in the lungs, resulting in frequent lung infections, breathing problems and decreased lung function. Highly structured, intense exercise regimens are difficult to adhere to long-term, so a team of researchers at Johns Hopkins Children's Center designed simple exercise programs tailored to patients' preferences and lifestyles. These activities included things such as going for a walk, playing basketball in the driveway, taking dancing lessons or playing with a Wii video game system. Lung function and exercise tolerance tests were given to 58 CF patients, aged 6 to 16, before and after they did their exercise programs for two months. ... Read more

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Drug Targets Faulty Process That Drives Cystic Fibrosis

Posted 18 Nov 2010 by Drugs.com

WEDNESDAY, Nov. 17 – A new drug focused on the underlying cause of cystic fibrosis is showing promise in Phase II clinical trials, new research shows. If eventually approved by the U.S. Food and Drug Administration, the drug known as VX-770 would mark the first treatment that gets at what goes wrong in the lungs of people with cystic fibrosis, rather than just the symptoms. Only 4 to 5 percent of cystic fibrosis patients have the particular genetic variant that the drug is being studied to treat, according to the study. But Robert Beall, president and CEO of the Cystic Fibrosis Foundation, said VX-770 is only the first in a new class of drugs, some of which are already in the pipeline, that may work in a similar way in people with other cystic fibrosis-linked gene variants. "There has never been such a sense of hope and optimism in the cystic fibrosis community," Beall said. "This is ... Read more

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Severe Bacterial Strain Found in Cystic Fibrosis Patients in Canada

Posted 16 Nov 2010 by Drugs.com

TUESDAY, Nov. 16 – Researchers have found that many cystic fibrosis (CF) patients in Canada have a common transmissible strain of the bacteria Pseudomonas aeruginosa, which can increase the risk of death or the need for a lung transplant. It's not known if the strain, first identified in the U.K., is yet common among CF patients in the United States. Researchers looked at 446 CF patients in Ontario and found that 102 of them were infected with one of two common strains. Sixty-seven were infected with strain A, 32 were infected with strain B, and three were infected with both strains. The study appears in the Nov. 17 issue of the Journal of the American Medical Association. According to background information in the study, the significant variation in the prognosis of patients with P aeruginosa may partly result from differences among infecting strains. Strain A was genetically ... Read more

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Bacteria Identified as New Foe for Cystic Fibrosis Patients

Posted 6 Oct 2010 by Drugs.com

WEDNESDAY, Oct. 6 – A new study links flare-ups of cystic fibrosis to a chronic bacterial infection, a finding that could give physicians new insight into the disease and offer a new target for medication. The germ in question is called Stenotrophomonas maltophilia. "Our study showed that chronic infection with S. maltophilia, which was previously not regarded as prognostically significant, may have a real impact on the progression of CF in patients," said study co-author Dr. Valerie Waters, an assistant professor of infectious diseases at the Hospital for Sick Children in Toronto. "We hope that this study is a starting point for further research, which may point to therapeutic possibilities associated with controlling these infections," she said in a news release from the American Thoracic Society. Cystic fibrosis is a congenital disease, meaning people are born with it. It produces ... Read more

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Cystic Fibrosis Flare-Ups May Be Treated Equally Well at Home

Posted 14 Jul 2010 by Drugs.com

WEDNESDAY, July 14 – Care at home or in the hospital is equally effective for cystic fibrosis patients recovering from respiratory flare-ups, a new study finds. The research also found that longer treatment with antibiotics doesn't appear to offer any additional benefits compared to shorter-term treatment. Johns Hopkins University researchers analyzed data from more than 1,500 cystic fibrosis (CF) patients. They found that respiratory exacerbations were often followed by long-term decline in lung function, regardless of whether patients were given antibiotics while in the hospital or at home. "Intravenous antibiotic therapy for CF respiratory exacerbations administered in the hospital and in the home may be equivalent in terms of long-term [lung function] change and interval between courses of antibiotics," study author Dr. J. Michael Collaco said in a Hopkins news release. ... Read more

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Drug-Resistant Staph Threatens Cystic Fibrosis Patients

Posted 15 Jun 2010 by Drugs.com

TUESDAY, June 15 – Cystic fibrosis patients with methicillin-resistant staphylococcus aureus (MRSA) in their respiratory tract have worse survival rates than those without the drug-resistant bacteria, researchers have found. The new study, published in the June 16 issue of the Journal of the American Medical Association, included 19,833 cystic fibrosis patients, aged 6 to 45, who were enrolled in the study from January 1996 to December 2006 and followed-up until December 2008. During the study period, 2,537 of the patients died and 5,759 had MRSA detected in their respiratory tract. The death rate was 27.7 per 1,000 patient-years among those with MRSA and 18.3 deaths per 1,000 patient-years for those without MRSA. After adjusting for a number of factors, the researchers concluded that the risk of death was 1.3 times higher for patients with MRSA. "These findings suggest that MRSA may ... Read more

Azithromycin Doesn't Always Help Lungs in Cystic Fibrosis Patients

Posted 4 May 2010 by Drugs.com

TUESDAY, May 4 – Treatment with the antibiotic azithromycin doesn't improve the lung function of children and teens with cystic fibrosis, U.S. researchers report. "A vicious cycle of infection and inflammation causes progressive lung destruction and premature death in patients with cystic fibrosis [CF]. Treatment strategies have therefore included both antimicrobial and anti-inflammatory agents," Dr. Lisa Saiman, of Columbia University in New York City, said in a news release. Over the past decade, studies have suggested that azithromycin, an antibiotic with both antimicrobial and anti-inflammatory activity, benefits CF patients. Azithromycin is recommended as therapy for CF patients with chronic infection with the bacteria Pseudomonas aeruginosa, but there has not been enough evidence to support the benefit of azithromycin in other patients with CF, the researchers wrote. This study, ... Read more

Pigs Yield Clues to Cystic Fibrosis-Related Lung Disease

Posted 28 Apr 2010 by Drugs.com

WEDNESDAY, April 28 – Researchers say they have answered a long-standing question regarding lung disease caused by cystic fibrosis: Which comes first, infection or inflammation? "Using our model, we are beginning to answer that question, and it looks like infection does precede inflammation," study author Dr. David Stoltz, an assistant professor of internal medicine at the University of Iowa, said in a news release from the school. "The importance of that finding is that it could dictate what types of therapy we might use. Knowing that infection is first suggests that if we can prevent or fight infection, then that might delay or prevent the lung disease in people with CF." Most of the deaths and disability in people with CF result from lung disease. The findings also appear to suggest that lung infections in children with cystic fibrosis should be treated early and aggressively, ... Read more

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