Join the 'Zurampic' group to help and get support from people like you.
FDA Approves Duzallo (lesinurad and allopurinol) for Hyperuricemia in Patients with Uncontrolled Gout
Posted 21 Aug 2017 by Drugs.com
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 21, 2017-- Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced Duzallo was approved by the U.S. Food and Drug Administration (FDA) as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone. Duzallo is not recommended for the treatment of asymptomatic hyperuricemia. Ironwood expects Duzallo to be commercially available early in the fourth quarter of 2017. Duzallo is the first drug that combines the current standard of care for the treatment of hyperuricemia associated with gout, allopurinol, with the most recent FDA-approved treatment for this condition, lesinurad. This fixed-dose combination provides a dual mechanism of action in a single tablet that can address both underlying causes of ... Read more
Posted 30 Dec 2015 by Drugs.com
December 22, 2015 – The U.S. Food and Drug Administration today approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body. Gout is a painful form of arthritis caused by the buildup of too much uric acid in the body, and usually appears first as redness, soreness, and swelling in the big toe. Uric acid in the blood is produced by the breakdown of substances called purines, which are found in all the body’s tissues. Uric acid usually dissolves in the blood then passes through the kidneys and out of the body in urine. Uric acid can build up in the blood, a condition called hyperuricemia. This occurs when the body increases the amount of uric acid it makes, the kidneys do not get rid of enough u ... Read more
Posted 23 Dec 2015 by Drugs.com
WEDNESDAY, Dec. 23, 2015 – Zurampic (lesinurad) has been approved by the U.S. Food and Drug Administration to control blood levels of uric acid associated with gout. Gout, a form of arthritis, commonly emerges as pain, redness and swelling in the big toe. Uric acid normally is a natural waste product that's passed through the kidneys. But when it builds up in the body, crystals may form and lead to gout. Zurampic, approved in combination with a second drug called xanthine oxidase, helps the kidneys avoid reabsorbing uric acid, then aids the kidneys in excreting uric acid from the body, the FDA said in a news release. Zurampic was evaluated in clinical studies involving more than 1,500 people. Those treated with the drug combination saw a drop in uric acid levels, compared to those who took placebos. The most common side effects of Zurampic included headache, a rise in a blood compound ... Read more