It’s the most common form of inflammatory arthritis in adults, often first appears as a painfully swollen big toe, and used to be called the “rich man’s disease,” because sufferers frequently consumed lots of meat, seafood, and alcohol: gout.
Now, the Cambridge drug maker Ironwood Pharmaceuticals Inc. has won Food and Drug Administration approval for a pill that can be taken once a day by patients who have not been able to control gout with other treatments.
The drug, called Duzallo, combines two other medicines in a formula that Ironwood hopes will be easier for patients to remember to take.
The company predicted that Duzallo, which was OK’d by regulators Monday, will generate more than $300 million in annual sales after it goes on the market by the fourth quarter of this year.
Gout is caused by high serum uric acid levels in the blood, which causes crystals to form and accumulate around a joint, resulting in severe pain. About 8 million to 10 million Americans suffer from the condition. Although diet and lifestyle changes can help manage it, gout is often hereditary and hard to control.
For decades, the standard treatment was a medicine called allopurinol, which is available as a generic drug but is only partially effective in many patients. About 4 million Americans take allopurinol, but roughly half continue to have gout flare-ups three to six times a year.
In October, Ironwood began marketing a second drug, Zurampic, which when taken with allopurinol roughly doubled the effectiveness of the older drug. But some patients had to take Zurampic once a day and allopurinol twice a day, making it more difficult for them to stick to the proper regimen.
“We wanted to make it really easy for the doctor and the patient, so we put the two together in this pill,” said Tom McCourt, chief commercial officer for Ironwood. Company officials feel Duzallo “will be the critical driver behind Ironwood’s gout franchise,” he said.
Dr. Michael A. Becker, professor emeritus at the University of Chicago, said the combination of two drugs in one pill marks an important advance.
“Gout is a serious and potentially progressive and debilitating inflammatory disease,” he said, adding that Duzallo will address a “significant unmet need among patients.”Jonathan Saltzman can be reached at email@example.com.