Extended Release Corticosteroid for Knee OA Pain

With tens of thousands of elective knee arthroplasty surgeries delayed and not likely to be re-scheduled until sometime between June and September, demand for interim knee pain relief is off the charts.

One of the most important innovations in pain management—an extended release corticosteroid that can provide as much as 90-day relief for osteoarthritis (OA) of the knee—is in robust supply according to its manufacturer, Flexion Therapeutics, Inc.

Flexion’s ZILRETTA^® is the only FDA approved, extended release corticosteroid injection on the market.

The reimbursed injection was approved by the FDA in October 2017 to treat osteoarthritis of the knee pain. Then, in December 2019, the FDA allowed Flexion to remove the phrase “not intended for repeat administration.”

Dr John Richmond, medical director for Network Development, New England Baptist Hospital, quoted by Flexion, added: “As both a clinician and a ZILRETTA patient, I have first-hand experience with the significant magnitude and duration of pain relief it can provide to people confronting knee OA. Zilretta is an invaluable non-opioid option for managing chronic OA knee pain, and it is encouraging to see a new product label that better informs clinical decision making.”

While acknowledging the impact of COVID-19 globally, Flexion President and Chief Executive Officer Mike Clayman, M.D. stated, “[W]e remain resolute in our commitment to ensuring that Flexion remains well positioned to provide meaningful medicines to patients in need and value to our investors for years to come.”

Dr. Clayman told OTW, “We very consciously built up our inventory because we expected substantial lift this year in sales. Ten months represents healthy inventory for us.  We have inventory in the U.S. in two different sites. We are in a good place for riding out this storm with that amount of inventory.”

He continued, “ZILRETTA is manufactured by a U.S.-based company—Patheon—that is using one of their sites in the U.K. That site is fully functional and we can make more product as we speak and we have active pharmaceutical ingredient there that would allow us to make another 12 months of inventory. We like where we are now and we will produce additional product as the need arises.”

Biopharmaceutical company Flexion Therapeutics focuses on the development and commercialization of therapies for patients with osteoarthritis knee pain.

ZILRETTA is an extended-release corticosteroid approved by the U.S. Food and Drug Administration (FDA) to manage osteoarthritis knee pain. Using proprietary technology, ZILRETTA provides extended pain relief through a combination of triamcinolone acetonide and a poly lactic-co-glycolic acid (PLGA) matrix. Triamcinolone acetonide is a corticosteroid approved by the FDA for the treatment of various conditions including joint pain.

For additional OTW coverage of ZILRETTA, see “How Athletes Respond to Extended Release Corticosteroids,” “Flexion: Full Zilretta Launch,” “Flexion Submits NDA for Zilretta,” “Flexion Therapeutics OA Drug Meets Primary Endpoint,” and “Flexion Therapeutics’ Drug Trumps Saline for OA Pain Relief.”