Osteoarthritis Drug Data Showing Promise

Osteoarthritis Drug Data Showing Promise

By Ed Coghlan

Is there new help coming for people who suffer from osteoarthritis (OA) of the knee, a leading cause of disability in the U.S.?

Flexion Therapeutics (NASDAQ: FLXN) released Phase 3 data this week for its lead product candidate Zilretta, a novel non-opioid investigational treatment for osteoarthritis (OA) of the knee.

The study which was randomized versus a placebo show that patients treated with Zilretta

  • achieved statistical significance on key assessments of pain, stiffness and function against both placebo and immediate-release triamcinolone acetonide through week 12
  • patients experienced, on average, a 50 percent reduction in pain from baseline over weeks 1 through 12

Zilretta is intended to provide localized and long-lasting pain relief over a period of months while minimizing systemic exposure and avoiding serious side effects common to oral therapies prescribed for OA pain. The FDA has granted Zilretta Fast Track designation. If approved, Zilretta would be the first sustained-release corticosteroid injection for OA of the knee and no alternative injectable therapy has been approved in more than a decade.

“Zilretta is a non-opioid and would be the first-ever sustained release steroid for intra-articular injections,” said Michael Clayman, M.D. Flexion President and Chief Executive Officer. “The clinical data to date demonstrate that Zilretta provides meaningful and durable pain relief and strongly support our plan to file the NDA for this new investigational medicine in the second half of this year.”

OA is a common joint disease that affects 27 million Americans, and the prevalence of the disease is expected to significantly grow as a result of aging, obesity and sports injuries. OA is a type of degenerative arthritis that is caused by the progressive breakdown and eventual loss of cartilage in one or more joints. OA is characterized by pain, swelling, stiffness and decreased mobility of the affected joint. While OA is being diagnosed at increasingly younger ages, prevalence rises after age 45, and the knee is one of the most commonly affected joints.

In 2014, more than 12 million Americans were diagnosed with OA of the knee. OA has a significant impact on the daily lives of patients, and it commonly affects large weight-bearing joints like the knees and hip but also occurs in the shoulders, hands, feet and spine. As the disease progresses, it becomes increasingly painful and debilitating, culminating, in many cases, in the need for total joint replacement.

If you have OA, how are you being treated?

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Authored by: Ed Coghlan