Flexion Therapeutics (NSDQ:FLXN) touted data today from a Phase II trial assessing the bilateral dosing of its extended-release triamcinolone acetonide injection in people with bilateral osteoarthritis.
The study found that bilateral injections of Flexion’s Zilretta therapy resulted in lower plasma concentrations of triamcinolone acetonide compared to immediate-release triamcinolone acetonide in crystalline suspension (TAcs). The company also noted that concurrent administration of Zilretta was well tolerated among the study’s participants.
The 24-patient Phase II study randomized participants to receive concurrent doses of either Zilretta or TAcs in both knees. The most common treatment-emergent adverse event in people given Zilretta was injection site pain, Flexion reported. In people treated with TAcs, the most common adverse events were arthralgia and joint swelling.
“Typically, physicians do not treat OA with corticosteroid injections in both knees at the same time due to concerns about potential systemic overexposure, which may require patients to return at a separate office visit to receive treatment in the second knee,” Dr. Scott Kelley, Flexion’s chief medical officer, said in prepared remarks.
“These results suggest that the extended-release formulation of Zilretta may result in substantially lower systemic concentrations of triamcinolone acetonide following bilateral injections compared to traditional immediate-release steroids. The findings add to the robust and growing body of data that has been generated to provide clinicians with a deeper understanding of Zilretta’s clinical profile,” Kelley added.
FLXN shares were trading at $17.08 apiece in mid-morning activity today, down -9.9%.