Flexion Therapeutics Inc said on Friday the U.S. Food and Drug Administration approved its injectable drug, Zilretta, to treat moderate-to-severe osteoarthritis-related knee pain, sending its shares soaring 18 percent.
The approval comes at a time when U.S. federal authorities are implementing a slew of measures to cut down the supply of opioid painkillers amid their continuous abuse, with President Donald Trump in August declaring the opioid epidemic a national emergency.
The drug would be priced at about $500 for a single injection, Flexion’s CEO Mike Clayman told Reuters, adding that it would be launched in the coming month.
Zilretta, a modified formulation of a commonly used corticosteroid, could bag potential peak sales of more than $750 million according to Northland Capital Markets analyst Carl Byrnes.
“Zilretta … has the potential to be a gamechanger in osteoarthritis knee pain treatment,” Wells Fargo analyst David Maris said in a client note ahead of the regulator’s decision.
Osteoarthritis knee pain is a degenerative joint disease that affected more than 14 million Americans in 2015.