New acne gel facing another FDA hurdle

Teenagers and other acne sufferers interested in trying the latest blemish-battling drug are out of luck for now.

A story April 14 in The News & Observer reported that a new prescription gel has emerged as a possible treatment for acne flare-ups worsened by stress. But the medicine, a gel form of the leprosy drug dapsone, is still not on the market despite its approval in 2005 by the U.S. Food and Drug Administration. It was the first major new medicine for acne to be approved in at least a decade.

The Canadian drug company that owns the rights to the gel, which is known as Aczone, has decided to delay its introduction. Clinical trials showed that some patients with an inherited enzyme deficiency developed anemia while using the gel. That led the FDA to require patient blood testing as a condition of approval -- a restriction the drug maker, QLT Inc., would like to shake.

QLT in November completed a clinical trial testing Aczone on more than 50 patients with the enzyme problem and has said the results were favorable. QLT plans to file papers no later than June 30 asking the FDA to remove the blood-testing requirement, a spokeswoman said Friday.

The company expects FDA's decision to come about 10 months after it files the request. That means it will be a year or more until Aczone is in patients' hands.

"There are limited options for teens that are actually effective," said Karen Palmer of Cary, whose 16-year-old son still struggles with pimples despite taking Accutane, an oral drug considered the gold standard for acne. She was intrigued by the new acne gel, which targets stress-related inflammation thought to increase the severity and duration of breakouts.

"I'm 51, and I still get acne," she said. "I might even try it myself."