(3/19/99)
WASHINGTON (AP) _ Diana Hind was bedridden with pain from shingles. Even
narcotic painkillers didn't help.
So her husband, a retired pharmaceutical chemist, mixed a different
painkiller in his laboratory. Now the LidoDerm patch not only has 80-year-old
Mrs. Hind back on her feet; on Friday, the Food and Drug Administration
approved its sale for up to 200,000 sufferers of shingles-caused pain.
The hand-sized, drug-filled patch has evolved a bit since Harry W. Hind
stuck his homemade salve onto his wife's back with Saran Wrap and tape.
"We had to make a more elegant way of doing this," Hind, 83, explained.
Mrs. Hind added: "You know, socially you can't go out with Saran Wrap around
you."
But at the time, she didn't mind the mess. "I could not have gone on with
that pain. There's no question about that," the San Jose, Calif., woman said.
Shingles is a risk to anyone who has ever had chickenpox. The chickenpox
virus, called herpes zoster, hibernates inside the body. As people age, the
immune system wanes and herpes zoster can reactivate, causing painful shingles.
Most people recover in a few months.
But for up to 20 percent of patients, shingles can damage nerves in the skin
and cause severe, unrelenting pain for months or even years. Narcotic
painkillers and a few other drugs offer some relief for this "postherpatic
neuralgia," but they all cause serious side effects.
When Mrs. Hind was stricken in 1989, a University of California, San
Francisco, doctor gave her just-under-the-skin injections once a week of the
anesthetic lidocaine. The series of shots, every half-inch across her back,
took 45 minutes and provided about six hours of pain relief. The injections had
to be performed carefully, because lidocaine that penetrates to the bloodstream
also can cause serious side effects.
Weaker versions of topical lidocaine numb the skin's surface, but they don't
penetrate to the nerves and so don't help postherpatic neuralgia, said Dr.
Bradley Galer of Beth Israel Medical Center in New York.
So Hind, who had run a company for years that developed eye and skin drugs,
revamped lidocaine to penetrate into the skin, just to the nerves, without all
those injections. He slathered his new solution onto his wife's back and taped
Saran Wrap over it to keep the goop in place overnight. The next morning, Mrs.
Hind says, she was without pain.
The FDA approved Hind's 5 percent lidocaine solution in a less-messy form
Friday, the LidoDerm patch. In studies, 60 to 70 percent of patients got pain
relief from LidoDerm, said Galer, who helped study the patch. Some patients
need new patches daily. With others, a single patch lasts a few days or a week.
"A big beauty of this ... is there are absolutely no systemic side effects,"
Galer said. "Within a week, most people know if it works or not."
The FDA did warn that lidocaine occasionally causes dangerous allergic
reactions and skin reddening or irritation. Also, patients must dispose of used
patches carefully, because they contain lidocaine that could be dangerous if a
pet or child ate it.
Endo Pharmaceuticals Inc. of Chadds Ford, Penn., will sell the patch
beginning in September. A price has not been set.
