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The approval comes at a time when U.S. federal authorities are implementing a slew of measures to combat opioid abuse, with President Donald Trump in August declaring the opioid epidemic a national emergency.
The osteoarthritis drug, Zilretta (triamcinolone acetonide extended-release injectable suspension), will treat moderate to severe knee pain. It would be priced at about $500 per shot and launched in October, Flexion’s CEO Mike Clayman tells Reuters.
The market for osteoarthritis drugs is expected to increase from $1.6 billion in 2016 to $3.5 billion by 2026, according to GlobalData.
“Zilretta … has the potential to be a gamechanger in osteoarthritis knee pain treatment,” Wells Fargo analyst David Maris says.
Zilretta could bag potential peak sales of more than $750 million, Northland Capital Markets analyst Carl Byrnes says.
Steroids move rapidly from joints into the blood elevating sugar levels in diabetic patients. Zilretta, however, is slowly released in the body and reaches the blood in much lower concentrations, preventing major changes in blood-glucose levels.
Development of rival drugs from Japan’s Seikagaku Corp and South Korea’s Kolon Life Science Inc. is underway.