Flexion Therapeutics ( FLXN ) rocketed as much as 19% late Friday after gaining U.S. approval for injectable non-opioid drug Zilretta to treat osteoarthritic knee pain, a disease that accounts for north of $185 billion in spending per year.
In late afternoon trading on the stock market today , Flexion popped as much as 18.9%, and ended the regular trading day up 10.4% to 29.93.
Flexion’s drug was approved to treat moderate-to-severe osteoarthritis knee pain based on a Phase 3 trial of 484 patients, Flexion said in a news release. Zilretta is an extended-release painkiller.
“The approval of Zilretta marks a major advancement in the treatment landscape for managing (osteoarthritis) knee pain,” Chief Executive Michael Clayman said in a prepared statement. “It comes at a time when our society is in urgent need of nonaddictive therapies to help the millions of Americans who suffer from this condition.”
Zilretta’s approval comes as U.S. federal authorities work to curb sales of addictive opioids and after President Donald Trump, in August, declared the opioid epidemic a national emergency. Opioids are associated with a euphoric feeling.
Some biotechs have had strong news this month, sending the group to a No. 1 spot among 197 groups tracked by IBD. Get the breakdown on this month’s winners via IBD Industry Themes .
RBC analyst Randall Stanicky called the approval a best-case scenario and reiterated his outperform rating on Flexion. He noted the label for Zilretta will include positive data from a study of the drug’s impact on patients with Type 2 diabetes.
According to trial officials, Zilretta may avoid the disruptive blood glucose spikes that can be seen with corticosteroid use in patients coping with both knee osteoarthritis and Type 2 diabetes. Stanicky sees $1.05 billion in 2023 sales for Flexion.
