Wonder drug?

Hershey, Pa. - May 21, 2008

It's called low dose naltrexone or LDN. Many patients who've tried it said it works and doesn't have bad side effects. But getting it to a pharmacy near you could be difficult.

Pam Sweigart of Annville, Lebanon County tries to keep up with her kids. But it wasn't always easy. Pam has Crohn's disease, a lifelong condition that causes swelling and sometimes ulcers in the digestive tract.

"It was so bad that I just would want to curl up in a ball," Pam said.

On and off Pam suffered severe stomach cramps, she lost 60 pounds and her hair was falling out.

Then she found something that helped. Pam enrolled in a clinical trial to test low dose naltrexone, or LDN. Right now, the drug is only approved in higher doses to treat heroin and opium addicts.

Researchers at Penn State College of Medicine in Hershey think a lower dose can help millions of patients with various diseases. Dr. Jill Smith has already proven in a small pilot study that LDN can decrease symptoms of Crohn's for some patients and improve quality of life.

"I just had no pain in my stomach, less headaches, my hair was growing back finally, I was gaining weight and able to keep weight on," Pam said.

Dr. Smith said LDN works by strengthening the body's own immune system instead of suppressing it like other drugs. "The with those medications is if you do suppress the immune system, you increase the chances of getting infections or even cancer longterm," Dr. Smith said.

So now Dr. Smith is rolling out phase two of the trial and hopes to get LDN closer to pharmacy shelves to treat other Crohn's patients. "We expect to find that there will be improvement and so far we're very pleased with our results," she said.

Dr. Ian Zagon is also excited about what's happening in his lab which is also at Penn State College of Medicine. He's using mice to see if LDN can slow down Parkinson's disease and Multiple Sclerosis. He started his research after hearing from patients themselves.

"They're able to walk better, they're able to have a better quality of life because they're taking LDN," said Dr. Zagon.

But in order to get government approval of LDN for any of these diseases larger nationwide studies are needed and funding could be a major obstacle.

Dr. Zagon said money for large studies often comes from big pharmaceutical companies. They invest early to reap the cash benefits that a new drug can bring in but because naltrexone isn't brand new, even if a company paid for all the studies, they're not guaranteed long term exclusive rights to sell the drug. And even if they can, it's not big money.

"LDN costs one-dollar a day to take, when you look at medicines like capaxone which is a medicine they use for M.S., this is running somewhere around $1,700 a month," said Dr. Zagon. "Pharmaceutical companies aren't interested because they do not have the financial incentive."

But Dr. Smith is optimistic and believes if she can get enough money to further test and prove LDN its impact could be huge.

Pam just hopes others get the chance to try it.

"I understand it's a money-making business but you also want, you want to help people get better."

The studies at Hershey are funded by the National Institutes of Health and the Broad Medical Research Program.

We did talk to representatives for Pharmaceutical Research and Manufacturing of America. They represent the leading pharmaceutical research and biotechnology companies. They did not want to speculate as to the involvement of individual pharmaceutical companies.

For more information on this or other clinical trials at Penn State College of Medicine visit: http://www.hmc.psu.edu/clinicaltrials/ or for more information on Crohn's Disease research, call 717 531-8108

Clinical trials are still ongoing, but LDN is available to patients as long as a doctor prescribes the drug for an off-label use. Prescriptions have to be taken to special compounding pharmacies. While many people are doing this, researchers still hope to have more enrolled in clinical trials so the drug can gain approval.

One reported side effect of LDN is sleep disturbances. Some patients report insomnia, others report vivid, sometimes scary dreams.

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