- Flexion Therapeutics, Inc. on Friday made the jump into the ranks of commercial biotech, securing an approval from the Food and Drug Administration for its injectable treatment for osteoarthritis knee pain.
- The drug, which will be marketed as Zilretta, combines the commonly used corticosteroid triamcinolone acetonide with a drug delivery system designed to provide extended pain relief over three months.
- Flexion plans to launch the drug commercially in late October at a price of $570 per dose. The Massachusetts-based biotech is pitching Zilretta as a needed non-surgical and non-opioid option to treat the chronic condition.
Flexion highlighted Zilretta's non-opioid analgesic profile as a key factor in the drug's potential as a treatment for osteoarthritis knee pain.
"[Approval of Zilretta] comes at a time when our society is in urgent need of non-addictive therapies to help the millions of Americans who suffer from this condition," said Flexion CEO Michael Clayman in a statement Friday.
Flexion has previously cited data estimating that 70% of osteoarthritis (OA) patients are prescribed opioids to manage their pain. With opioid overdose deaths in the U.S. continuing to mount and heightened scrutiny on the addictive nature of many opioids, physicians and pharma companies alike have been looking for other options.
In a nearly 500-patient Phase 3 study, Zilretta significantly lowered pain intensity scores compared to placebo three months following administration. A secondary analysis comparing Zilretta to an active control of immediate-release triamcinolone acetonide showed numerically superior reduction but failed to hit statistical significance.
Flexion, though, is also touting Zilretta's muted effect on blood sugar levels. Spikes in blood glucose levels are a known potential side effect of corticosteroids. Roughly one-fifth of OA patients have type 2 diabetes, meaning a pain treatment with a reduced risk of increasing blood sugar would likely be viewed more favorably by physicians.
A small study of Zilretta with type 2 diabetes patients showed treatment with the drug led to a significantly smaller increase in blood glucose levels than other formulations of triamcinolone acetonide.
In a boost to the biotech, the FDA included data from that study on the drug's label, giving the company the ability to advertise that benefit to physicians and patients.
Shares in Flexion closed more than 10% higher in value Friday, although Monday morning trading had pared back a large portion of those gains.