A long-acting steroid from Flexion Therapeutics intended for treating pain experienced by osteoarthritis patients has been deemed effective in a late-stage study, taking the company closer to its first marketing approval in the United States.
Flexion reported that the Phase 3 clinical trial for Zilretta met its goals and demonstrated “highly significant, durable and clinically meaningful pain relief” compared with a placebo in those suffering from moderate to severe osteoarthritis knee pain.
“We believe that Zilretta has the potential to become an important new non-opioid treatment in a therapeutic area that hasn’t seen meaningful innovation in many years,” says Flexion President and CEO Dr. Michael Clayman.
The news came months after the drug failed to show statistically significant pain relief in a mid-stage trial that involved around 200 patients. The results led the company’s shares to plummet last fall.
Clayman said that they “could not be more confident” that they will win FDA approval for the medication.
In the trial that involved 486 patients, participants reported pain levels at weekly intervals over a four-month period. They received Zilretta, placebo, or the immediate-release steroid known as triamcinolone acetonide, which is commonly used for treating knee conditions.
Those on Zilretta reported an average of about half of the pain level of those on placebo from first to 12th week.
Several analysts contended that week 12 results might as well be a fluke, since Zilretta seemed to work well at every other week pre- and post-final measurement period. Others, however, highlight Zilretta’s potential to serve as the standard of care.
"I think this [data] blows a lot of the current therapies out of the water if you just look at efficacy numbers," says Chiara Russo of Cantor Fitzgerald.
Flexion’s shares climbed by about 38 percent last Tuesday following the announcement, with Zilretta poised to rake in at least half a billion dollars in peak sales in the U.S.
A form of degenerative arthritis that afflicts 27 million in America, osteoarthritis results from the progressive cartilage breakdown and loss. It is marked by swelling, pain, and reduced mobility of the affected joint.
Opioids and most therapies for osteoarthritis today are believed to offer limited effectiveness, as well as pose a number of serious side effects.
Zilretta is forecasted to hit the U.S. market by 2017’s second half, granted that the FDA does not take into account the failed earlier study.
Photo: Garry Knight | Flickr
