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Study Supports Health Benefits Of Smoking Ban

From The Wall Street Journal:

A new study from Scotland provides what public-health experts in the U.S. say is the strongest evidence yet that public bans on smoking -- being debated in several locales -- improve health by reducing exposure to secondhand smoke.

According to the study, which appears in Thursday's edition of the New England Journal of Medicine, hospital admissions for heart attacks and acute coronary problems fell 17% overall, and even more for nonsmokers, in the year after Scotland banned smoking in public places.

"There has long been a claim from smokers that they are affecting their own bodies, and why should the public care?" said David Cohen, director of cardiovascular research at Saint Luke's Mid America Heart Institute in Kansas City, Mo., who wasn't involved in the study. "This shows that the public should absolutely care ... that is an incredibly powerful finding."

The study found that nonsmokers accounted for 67% of the overall reduction in heart-disease hospitalizations, said Jill Pell, the University of Glasgow professor who led the study. Nonsmokers saw a 20% reduction in their hospital admissions following the ban. Smokers' admissions were down 14%.

This isn't the first study published on the health impact of smoking bans -- the 17% decrease in hospitalizations among Scots was comparable to rates recorded in previous research. But these findings "should add considerable oomph to the pressure for smoking bans" elsewhere, because of the study's rigor and use of blood tests, said Edith Balbach, director of the Community Health Program at Tufts University and president of Americans for Nonsmokers' Rights.

Unlike past studies, researchers took blood and saliva samples from patients as they were admitted to the hospital. Then they searched for a molecule that's the product of nicotine metabolism -- cotinine. The presence of cotinine can definitively classify patients as smokers or nonsmokers instead of relying on self-reporting by patients.

Researchers found that nonsmokers with heart disease had higher levels of cotinine than the general population but lower levels than before the ban, a sign that their exposure to secondhand smoke had decreased but was still a factor in their heart damage.

Inhaled smoke makes blood platelets stickier, thus more likely to clot and clog arteries -- after even brief exposure to low levels of smoke. But the increased stickiness can wear off after just a few days. These effects make heart disease the most immediate health risk of tobacco smoke, and reducing these effects provides the most immediate benefit of smoking bans, according to public-health experts.

Support for state and local smoke-free laws has grown in recent years; still, such bans face strong opposition in many areas, especially in the Midwest and South. Opponents typically include small-business and restaurant owners, who say bans reduce their revenues, and libertarian groups.

There has been little action at the federal level since an executive order signed by President Bill Clinton ended smoking in federal buildings in 1997. Antismoking groups prefer to target local and state governments.

More than 60% of the U.S. population is covered by some type of smoking ban at the state or local level, usually restricting smoking in either public areas or workplaces, according to Americans for Nonsmokers' Rights. More comprehensive bans like Scotland's -- which prohibited smoking in all enclosed public areas and workplaces after March 2006 -- are now law in 14 states, up from three in 2005, according to the Centers for Disease Control and Prevention.

The economic impact of smoking bans is still hotly debated in state and local governments. But academic researchers are less divided. On the basis of numerous peer-reviewed studies, the Surgeon General's Office issued a report in 2006 concluding that "smoke-free policies and regulations do not have an adverse economic impact on the hospitality industry" -- a conclusion the tobacco industry disputes.

"We think that people should be able to avoid being around second-hand smoke, especially in places they must go, such as government buildings and public transportation," said Bill Phelps, a spokesman for Altria Group Inc., which owns cigarette maker Philip Morris USA. But he added that "business owners, particularly those who own restaurants and bars, should be able determine smoking policy for their own businesses."

There are about one million hospitalizations for acute coronary syndrome in the U.S. every year, Dr. Cohen said. Each episode generally costs between $10,000-$20,000 to treat, pegging the cost of this care at $10 billion per year or more, he said.

Posted: 7/31/2008 12:05:00 PM

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Precise Low-Dose Drug Monitoring Essential for Long-Term Kidney Transplant Success

From The Earth Times:

The ability of blood tests to precisely measure very low doses of anti-rejection drugs in kidney transplant patients may make a significant difference in assuring long-term viability and survival, according to research presented today at the American Association for Clinical Chemistry (AACC) annual meeting.

The current thinking in transplant medicine favors reducing doses of tacrolimus and other immune-suppressive drugs as much as possible after kidney-transplant procedures. "Even though we are succeeding in preventing organ rejection, we haven't made much progress to improve long-term survival," said Sudarshan Hebbar, M.D., senior medical director, Abbott Diagnostics.  "Unfortunately, most kidney transplant patients will go back on dialysis in eight to ten years, in part because the anti-rejection drugs can be toxic to the kidneys."

Dr. Hebbar added that kidney-transplant patients have high incidence of heart attacks and other cardiovascular disorders from long-term effects of renal disease. Therefore, minimizing drug toxicity over time is considered one way to help improve long-term graft survival and preserve quality of life for transplant patients.

To minimize long-term toxicity of transplant medications, physicians frequently aim to taper down doses of immunosuppressive drugs to as low a level as possible without risking rejection. "Successful low-dose regimens of tacrolimus and other anti-rejection medications require highly precise, ultra-sensitive drug-monitoring assays," said Daniel Levine, Ph.D., director of the clinical laboratory, Iris and B. Gerald Cantor Clinical Research Laboratory at The Rogosin Institute in New York City.

Dr. Levine emphasized the importance of using an accurate and precise test to monitor patients on low-dose treatment regimens. "At low doses, even the slightest variation in blood-level readings could be devastating to transplant patients. The consequence for the laboratory is twofold: it must have accurate, precise testing for immunosuppressive drugs, and tacrolimus tests that are accurate to 4 ng/mL are no longer adequate," he explained.

Dr. Levine reported results of his studies evaluating the performance of the Abbott ARCHITECT assay for tacrolimus, the most widely used immunosuppressant drug. He said the usual dosing range for the medication is between 2 and 15 ng/mL, with lower doses preferred. "The challenge for the laboratory, therefore, is to assure with the utmost confidence to the physician that a tacrolimus blood level of 3 ng/mL is exactly right and not 5," Levine said.

Posted: 7/31/2008 9:50:00 AM

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Anti-dementia drugs increase lifespan for Alzheimer's patients who take them

From Baylor College of Medicine:

Persistent use of anti-dementia drugs during the course of Alzheimer's disease appears to increase life expectancy, said researchers at Baylor College of Medicine in Houston at a presentation at the Alzheimer's Association International Conference on Alzheimer's Disease 2008 in Chicago today.

"The life span of those with Alzheimer's is known to be shorter than that of cognitively healthy people," said Dr. Susan Rountree, assistant professor of neurology at BCM and lead author of the study. "Our findings suggest that those who took anti-dementia drugs more persistently, or longer time intervals, lived longer than those who took the medications for shorter time periods."

Additional 3.12 years
The study followed 641 people suffering from Alzheimer's disease between 1989 and 2005. All were on one or more commercially available anti-dementia drugs for varying amounts of time during the course of their illness. The drugs included donepezil, galantamine, rivastigmine, tacrine or memantine.

Researchers gave each subject a "persistency" score derived by dividing the total years that they took the medication by the total years that they had symptoms of the disease. They used these results to divide the patients into four quartiles, lowest to highest.

"We did take into account a variety of factors that influence life expectancy such as age and other diseases," Rountree said.

Those in the first quartile, the lowest persistency group, were 2.4 times more likely to die than those in the fourth quartile, or highest persistency group. Those within the second and third quartiles had an increased risk of death of 2.2 times and 1.5 times respectively, compared to those with the highest score. Those who had the higher scores lived, on average, 3.12 years longer than those with the lower scores.

Posted: 7/31/2008 9:40:00 AM

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Experimental Alzheimer's drug shows early promise

From USA Today:

Alzheimer's researchers from Scotland announced on Tuesday that for the first time they have developed a drug that can halt cognitive decline in patients with mild and moderate Alzheimer's disease.

In the largest Phase II clinical trial of its kind, study author Claude Wischik, professor at the University of Aberdeen in the U.K. and executive chairman of TauRx Therapeutics, said that TauRx's drug methylthioninium chloride (MTC) was successful at halting the symptoms of Alzheimer's disease over a 50-week period.

Previous research has shown that a buildup of abnormal nerve fibers in the brain, made up of a protein called tau, is linked to memory loss in Alzheimer's disease. Rember, the brand name of the drug, had been successful at melting tau tangles in lab tests and in animal studies, but this is the first time an anti-tau drug has demonstrated benefits in people with Alzheimer's disease.

In Wischik's study, 321 people with either mild or moderate Alzheimer's disease were given a placebo or one of three doses — 30, 60 or 100 milligrams — of MTC three times a day for up to 84 weeks. Imaging scans were taken at the beginning of the study and again at 24 weeks. Patients' cognitive abilities were measured at 24, 50 and 84 weeks.

At 24 weeks, there was a decline in disease progression in only the patients with moderate Alzheimer's who were taking 60-mg capsules. But by 50 weeks, patients with mild and moderate Alzheimer's taking the medium and highest doses of the drug also saw a benefit, according to the researchers.

Wischik says the drug appeared to be reasonably well tolerated.

But some of Wischik's peers say it's too early to make such claims.

Wischik says he is swimming against the research tide. "The main story in town for the last 20 years has been attacking amyloid plaque. A lot of people have said it's too late to treat the tangles, but that's bunkum," he says. Amyloid proteins form plaque outside brain cells, whereas tau proteins develop inside nerve cells.

A drug with multiple targets may be the answer, says Scott Turner, incoming director of the memory disorders program at Georgetown University Medical Center. "I think we may ultimately be treating with a drug cocktail that includes both anti-tau and anti-amyloid properties," he says.

And from Bloomberg:

TauRx Alzheimer's Drug Slowed Patients' Decline for a Year

A chemical used to dye body parts for surgery, treat a blood disorder and clear fungal infections in fish may also be a new weapon against Alzheimer's, a study by a Singapore company suggests.

The compound, methylene blue, helped improve cognitive scores of Alzheimer's patients compared with a placebo, according to the study by the company, TauRx Therapeutics Ltd. The data was presented today in Chicago at the International Conference on Alzheimer's Disease.

TauRx's experimental drug, called Rember, is aimed at an abnormal version of a protein known as tau that's linked to Alzheimer's. When healthy, tau supplies nutrients to nerve cells in the brain. When damaged, it creates tangles that shut off nutrients. The treatment may offer an alternative to other experimental compounds that target beta amyloid, a more widely studied protein tied to Alzheimer's.

``You can have two patients with the same amounts of amyloid and one can play bridge and the other can't find the way to the toilet,'' said the lead author, Claude Wischik, who is chairman of TauRx and a professor at the University of Aberdeen, Scotland, last week in a telephone interview. ``What we're presenting is an alternative approach.''

Tau is tied to brain cell death, and may be more closely associated with dementia from Alzheimer's than beta amyloid, scientists said. Rember prevents the aggregation of tau proteins and dissolves the tau tangles, Wischik said.

The most common side effects in the study were diarrhea and discolored urine. Methylene blue has had many medical uses over the years, including killing bacteria in the urinary tract and as treatment for malaria and gonorrhea. The chemical is also being studied in bipolar disorder, according to Bloomberg data.

Alzheimer's will claim about 1 in 8 baby boomers, those born between 1946 and 1964, or about 10 million Americans.

Posted: 7/30/2008 10:33:00 AM

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Home deaths from drug errors soar

From the Associated Press:

Deaths from medication mistakes at home, such as actor Heath Ledger's accidental overdose, rose dramatically during the past two decades, an analysis of U.S. death certificates finds.

The authors blame soaring home use of prescription painkillers and other potent drugs, which 25 years ago were given mainly inside hospitals.

"The amount of medical supervision is going down and the amount of responsibility put on the patient's shoulders is going up," said lead author David P. Phillips of the University of California, San Diego.

The findings, based on nearly 50 million U.S. death certificates, are published in Monday's Archives of Internal Medicine. Of those, more than 224,000 involved fatal medication errors, including overdoses and mixing prescription drugs with alcohol or street drugs.

Deaths from medication mistakes at home increased from 1,132 deaths in 1983 to 12,426 in 2004. Adjusted for population growth, that amounts to an increase of more than 700 percent during that time.

In contrast, there was only a 5 percent increase in fatal medication errors away from home, including hospitals, and not involving alcohol or street drugs.

Abuse of prescription drugs plays a role, but it's unclear how much. Valid prescriptions taken in error, especially narcotics such as methadone and oxycodone, account for a growing number of deaths, said experts who reviewed the study.

The increases coincided with changing attitudes about painkillers among doctors who now regard pain management as a key to healing. Multiple prescription drugs taken at once -- like the sleeping pills, painkillers and anxiety drugs that killed "Dark Knight" star Ledger -- also play a part, experts said.

But Phillips said there were no significant increases in other poisonings, such as suicidal overdoses or homicides, so more testing doesn't explain the huge increase. The analysis excluded suicides, homicides and deaths related to side effects.

The increase was steepest in death rates from mixing medicine with alcohol or street drugs at home; that death rate climbed from 0.04 per 100,000 people in 1983 to 1.29 per 100,000 people in 2004.

The increase in deaths was highest among baby boomers, people in their 40s and 50s.

People share prescriptions at an alarming rate, Bootman said. One recent study found 23 percent of people say they have loaned their prescription medicine to someone else and 27 percent say they have borrowed someone else's prescription drugs.

Michael R. Cohen, president of the Institute for Safe Medication Practices, said more states should require pharmacists to teach patients about dangerous drugs and insurers should pay pharmacists to do so.

Posted: 7/30/2008 10:30:00 AM

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Presence of migrated heavy metals was found in pacifier samples

From The Telegraph (Calcutta, India):

The Consumer Education and Research Society (CERS), Ahmedabad, tested a range of pacifiers, teethers and nipples for the presence of migrated heavy metals (lead, cadmium and chromium), considering their high toxicity. The findings are so alarming that CERS published the report without testing larger sample sizes.

Scientists and experts are of the opinion that the presence of metals like lead, cadmium and chromium, even in the smallest amount, is hazardous to health. Even the faintest trace of these metals in pacifiers, teethers and nipples, meant for sucking and biting, can pose a health risk to infants.

The lead content in toys has become a global issue. But there are no separate standards for infant toys like pacifiers, nipples and teethers.

Infant toys cannot be clubbed with children’s toys. These toys are meant for sucking and biting over a period of time, owing to which the toxic elements easily leak out with the saliva and get ingested into the body. 

A total of eight samples of pacifiers, teethers and nipples were tested for migrated elemental lead (Pb), calcium (Cd) and chromium (Cr). The results revealed that none of the toy samples was free from lead. The migrated lead content varied from 2.7 to 9.6 ppm (parts per million). Although this figure complies with the standards set by the BIS (Bureau of Indian Standards), the presence of lead is not acceptable, particularly in infant toys.

Nuby Natural Flex Pacifier contained 5.5 ppm of lead and Disney Baby Soother and Holder Set had 5.6 ppm of lead. Out of the three teethers tested, Mom’s and Me water-filled teether had the highest lead content (9.6 ppm), while Fisher Price Penguin water-filled teether had the lowest amount of lead (5.4 ppm). The Yash Yellow rubber nipple had the highest lead content (4.8 ppm) and Piyu silicon rubber nipple had the lowest (2.7 ppm). This is dangerous because the chewing and swallowing of toys by infants make them more vulnerable to toxic lead.

Cadmium, a heavy metal used as stabilisers in plastic and paints, was found in all the samples tested. The samples contained cadmium in a range of 0.1 to 0.6 ppm. In the pacifiers tested, the Nuby brand had more cadmium (0.6 ppm) than Disney (0.1 ppm). Mom’s and Me had more cadmium (0.3ppm) than Lucky and Fisher Price. Both these brands had 0.2 ppm of cadmium. Yash Yellow had the lowest amount of cadmium (0.1 ppm) while Alfa silicon rubber nipple had the maximum (0.4 ppm).

Cadmium is a nephrotoxin which can damage the kidneys. Ingestion of cadmium may cause abdominal pain, nausea and even death. Even a small quantity of cadmium may pose a great danger to an infant’s body.

Traces of chromium were found in all the samples tested. The amount of migrated chromium varied from 0.4 to 5.0 ppm. The Nuby Natural Flex Pacifier had a chromium content of 2.8 ppm. Out of the three teethers tested Mom’s and Me water-filled teether contained the highest amount of chromium (5.0 ppm). Alfa silicon rubber nipple contained 4.4 ppm of chromium while Yash Yellow rubber nipple contained the least (1.0 ppm).

Like lead and cadmium, chromium is also considered toxic. Highly toxic Cr (VI) may cause irritation and asthma attacks. Young people may be more susceptible to toxic effects of chromium than adults.

Commenting on the test results, Mattel Inc. said it does not use lead or cadmium compound as stabilisers for plastics or PVC. The minute amount of lead detected may have resulted from exposure to dust, equipment or even water. The mere detection of lead at these levels, which are below the regulatory standards, doesn’t equate to a health risk.

CERS stresses that the test samples were completely sealed, having no room for dust. The laboratory uses good quality triple distilled water, which has almost zero lead content. Hence the lead content measured in the test sample of Fisher Price Penguin water teether was from the sample only.

Posted: 7/28/2008 4:12:00 PM

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Testing of Pregabaline as hot-flash medication for women

From The News-Gazette:

Medical experts have tried everything from herbal remedies to anti-depressants to help relieve hot flashes in menopausal women.

Now, researchers at Carle Clinic and more than 100 other medical sites around the country will begin testing a remedy on women that has already been shown to work for men who get hot flashes as a result of hormone treatments for prostate cancer.

The medication being tested, Pregabalin, is taken orally, and is currently approved to treat nerve pain, fibromyalgia and seizures.

Dr. Kendrith Rowland, principal investigator of oncology research at Carle Clinic, described it as a "safe, non-hormonal drug" that will likely work for women with hot flashes just as it has for men.

Now researchers just need some women willing to try it.

Carle has enrolled nine women in a Pregabalin clinical trial, and is looking for more. Nationwide, the trial will be limited to 192 patients, said Janet Iverson, a clinical research professional at Carle.

It's about time medical science addressed this problem for women, she said.

"We really don't have a good standard of care out there for women who are experiencing this," she added.

Carle is among 123 research locations participating in the Pregabalin trial sponsored by the North Central Cancer Treatment Group based at Mayo Clinic in Rochester, Minn.

Posted: 7/26/2008 1:01:00 PM

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US fentanyl deaths topped 1,000 over 2 years

From The Associated Press:

More than 1,000 people died over two years from an illegal version of the painkiller fentanyl, the government reported Thursday in its first national tally of those deaths.

The spike of overdoses seems to have ended, health officials said, pointing to law enforcement's shutdown of a fentanyl operation in Mexico in 2006.

The wave of fentanyl overdoses first came to light in Chicago in 2005, and by 2006 more clusters were identified in Philadelphia, Detroit and other cities.

Hundreds of deaths from the drug were gradually reported, often episodically in local newspapers. Thursday's report from the Centers for Disease Control and Prevention puts the toll at 1,013 deaths from early April 2005 through late March 2007.

"This was really an epidemic," said Dr. Steven Marcus, the executive director of New Jersey's poison control center and a co-author of the new report.

Some deaths from illegal fentanyl still occur, but the worst of the outbreak seems to have ended after authorities shut down a fentanyl-making operation in Toluca, Mexico, in May 2006, said Dr. T. Stephen Jones, the study's lead author.

Fentanyl is a prescription painkiller, often prescribed for cancer patients and administered through a patch. But it also is a powerful, euphoria-inducing narcotic, 30 to 50 times more potent than heroin.

Illegally made versions of the drug are sold as a powder, often mixed with cocaine or heroin, and sometimes used as a heroin replacement. It's possible some heroin addicts are unaware fentanyl is part of their injection, some experts say.

Smaller outbreaks of fentanyl-associated deaths in addicts have been reported before, including the "China White" outbreak of the 1980s, famed for being so deadly that drug users dropped dead with needles still in their arms.

The latest outbreak was first noted in Chicago. Patients who recovered from overdoses said they had been given free heroin in orange and pink plastic bags by new drug dealers trying to attract more customers.

It wasn't until a cluster of overdoses seen in Camden, N.J., emergency rooms in April 2006 that federal officials were notified of the problem, by Marcus.

The resulting investigation was unusual, because some health officials have been reluctant to spend time and energy investigating deaths related to illicit drugs, Marcus said.

"The response when I deal with public health officials is; 'Drug abuse is a dangerous habit, and drug abusers know it's a dangerous habit, so why are we making a big deal out of it?'" he said.

The report distinguished deaths due to illegally made fentanyl from those due to illicit use of the pharmaceutical product. Medical examiners cannot tell the difference from what's seen in an autopsy, so investigators relied on drugs found at the scene and other information to separate the two.

Also, the investigators did not count cases in every city. The tally covers only two states — New Jersey and Delaware — and the cities of Chicago, Detroit, Philadelphia and St. Louis.

"It's an incomplete picture," Jones said.

National health statistics show the death rate from unintentional drug poisonings — most of them illicit drug overdoses — roughly doubled from 1999 to 2005.

Posted: 7/25/2008 9:26:00 AM

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Extreme Drunk Driving: Blood-Alcohol Tests Indicate They Should Be Dead, Instead They're Driving

From ABC News:

A Rhode Island man arrested this week for drunk driving had a potentially lethal blood-alcohol level at the highest ever recorded by police, setting a new state record.

Stanley Kobierowski, 34, was arrested in Providence, R.I., after smashing his car into an electronic message sign. According to state police, he allegedly blew a .489 and .491 on a Breathalyzer at the scene. That's more than six times the state's legal limit. He was brought to a local hospital and held for two days until sober enough to be arraigned, police said.

Kobierowski may be Rhode Island's record-setting drunk driver, but across the country police are reporting incidents of extreme drunk driving with recorded blood-alcohol levels reaching limits that doctors say would be lethal to most people.

The record-breaking levels have inspired some states to require convicted drunk drivers who have tested well over the legal limit to install in their cars ignition interlock devices that prevent drunks from starting the automobile.

No national statistics exist on BAC levels at time of arrest, but recent news reports pose an intriguing question: How do these drivers function, let alone live, with potentially deadly amounts of alcohol in their systems?

In November 2007, a 130-pound woman was arrested in Oregon with a blood-alcohol level of .55, seven times the state's legal limit and above the .4 concentration considered lethal according to physicians.

A BAC level of .55, according to the Rutgers University Center of Alcohol Studies, would require a 100-pound man or woman to consume roughly 10 drinks in an hour or a 200-pound man to drink about six drinks each hour for four hours.

In December 2007, Terri Comer, 42, and also from Oregon, was arrested with a .72 blood alcohol level, nine times the state's legal limit.

Klanath County sheriff's deputies found the woman behind the wheel of her Toyota in a coma. Police said they removed the woman from her car and brought her to a local hospital for treatment. Photos of the scene show her car parked in a snow bank just feet from an electronic sign reminding drivers not to drink and drive.

"Levels between .4 and .5 are fatal in most cases," said Dr. Nicholas Pace, a professor at NYU School of Medicine and author of "Teens Under the Influence."

Other factors -- weight, gender, underlying medical conditions, the amount of food consumed while drinking -- can affect someone's BAC, said Dr. Lawrence S. Brown, a professor at the Cornell School of Medicine and senior vice president of the Addiction Research and Treatment Corp.

"With respect to high levels and lethality, all of the above mentioned are factors to consider, and you still have to account for the way the tests were done -- who calibrated the instruments and who performed the test. Those concerns have legal and clinical ramifications," he said.

Perhaps the highest recorded BAC level in a person who lived was reported in 2005 in the southern Bulgarian city of Plovdiv.

According to the CBC and other international reports, doctors tested a man's blood-alcohol level five times before accepting it was .914 -- twice the amount considered to be fatal.

Posted: 7/24/2008 2:20:00 PM

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The Michael J. Fox Foundation Awards Depomed a Preclinical Development Grant for Levodopa/Carbidopa in Parkinson's Disease

From MarketWatch:

Depomed, Inc. announced today that it has been awarded a preclinical grant by The Michael J. Fox Foundation under the foundation's Therapeutics Development Initiative 2008 Program. The modest grant amount supports Depomed in the development of novel gastric retentive controlled-release dosage forms of Levodopa/Carbidopa under the hypothesis that Levodopa/Carbidopa's window of absorption in the upper gastrointestinal tract can be optimized using Depomed's AcuForm(TM) technology. Conceptually, gastric retentive controlled-release could smooth out blood level fluctuations of Levodopa/Carbidopa and lead to more consistent efficacy. One of the major unmet needs in the treatment of Parkinson's Disease, or PD, is inconsistent efficacy and 4-6 times daily dosing of Levodopa/Carbidopa.

Posted: 7/23/2008 4:11:00 PM

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