A pioneering drug developed to combat a disfiguring hand disorder has moved a critical step forward in the federal regulatory process to treat a painful condition known as frozen shoulder.
The condition affects up to 5 percent of the adult population, and some people afflicted in early stages may not know they have it, said one of the drug's key developers at Stony Brook University Hospital.
The enzyme-based treatment, developed by Drs. Marie Badalamente and Edward Wang, could end the need for steroid injections, extensive physical therapy, surgery and its painful aftermath, now the standard of care for frozen shoulder.
"These are injection treatments," Badalamente said Thursday of a drug known commercially as Xiaflex, but whose scientific name is collagenase clostridium histolyticum, or CCH.
Patients in clinical trials generally receive three injections.
The drug was approved in 2010 to treat a hand condition called Dupuytren's contracture or Dupuytren's disease, which contorts the affected hand making even simple tasks impossible. In some instances, the hand takes on a claw-like appearance.
Though it's approved for use in Dupuytren's, the U.S. Food and Drug Administration requires a new round of clinical trials to prove the drug works effectively against frozen shoulder.
Badalamente said Thursday that she and her colleagues at 25 centers across the country have advanced to the regulatory phase known as 2b, which means doctors know the drug effectively treats frozen shoulder and are fine-tuning the dosage. Ten centers in Australia are also conducting clinical trials, she said.
Frozen shoulder diminishes patients' range of motion, Badalamente said, and some patients are unable to dress themselves or brush their teeth.
Technically known as adhesive capsulitis, frozen shoulder is marked by inflammation and adhesions in the shoulder's capsule. The adhesions are composed of tough collagen proteins, the same fibrous substance that marks Dupuytren's.
The catalytic action of the enzyme collagenase -- the backbone substance in Xiaflex -- breaks down the offending adhesions.
Frozen shoulder generally strikes between the ages of 40 and 60, affecting women more frequently than men.
No one knows the precise cause, although it can occur after accidents or surgery. Often, the cause remains unknown.
Wang said if the drug is approved -- and he's certain it will be -- patients will have a form of treatment allowing them to quickly resume normal shoulder function.
"Obviously, I am very excited because we are seeing very promising results," Wang said Thursday.
"We started this almost 10 years ago," he said, referring to the drug's development, "and I am very optimistic that this will become the treatment for frozen shoulder."
He said a large percentage of patients don't bother to seek medical care until they have lost much of their shoulder motion when they could be helped by being treated sooner.
The clinical trial, the doctors said, is still enrolling patients.
Kim Russo, 52, of Holbrook experienced frozen shoulder twice. First in her left shoulder in 2011 when she underwent surgery to regain motion, and again, a year ago when frozen shoulder struck her right side.
"I only needed two injections," Russo said, noting that the Stony Brook team found she had improved so well, she could forgo the third shot.