FDA News

FDA grants fast track designation to CNTX-4975 injection for osteoarthritis knee pain

Randall M. Stevens, MD
Randall M. Stevens

The FDA granted fast track designation to a synthetic, ultra-pure injection of trans-capsaicin for the treatment of pain linked with knee osteoarthritis, according to the drug’s manufacturer.

Centrexion Therapeutics designed CNTX-4975 for injection directly at the site of joint pain to provide rapid onset analgesia and long duration of relief among patients with moderate-to-severe osteoarthritis knee pain.

“Osteoarthritis is a rapidly escalating public health issue projected to affect nearly 67 million Americans by 2030 — it is absolutely critical that we continue to advance new pain treatments like CNTX-4975 that have the potential to relieve pain and improve stiffness and function, while avoiding the significant challenges and side effects of currently available therapies,” Randall M. Stevens, MD, chief medical officer for Centrexion Therapeutics, said in a press release. “This is an important milestone for both Centrexion and the millions of people suffering from pain associated with knee osteoarthritis.”

The FDA based its decision on efficacy and safety results from the dose-ranging 24-week phase 2b TRIUMPH clinical trial, which evaluated patients with stable, chronic moderate-to-severe osteoarthritis knee pain who failed previous oral/intra-articular analgesics.

Study results demonstrated statistically significant pain relief continuing through 24 weeks from a single 1 mg injection of CNTX-4975, as well as statistically and clinically significant improved knee stiffness and physical function during the trial in patients with moderate-to-severe knee osteoarthritis pain. Further, researchers determined CNTX-4975 to be well-tolerated with a safety profile similar to placebo.

“With the fast track approval, we look forward to additional interactions with the FDA to optimize the development of this novel, non-opioid, non-addictive pain treatment,” Stevens said in the release. “We look forward to building on the momentum of our CNTX-4975 program with the initiation of our phase 3 program in patients with moderate-to-severe knee osteoarthritis in the first quarter of 2018.”

The FDA provides fast track status to facilitate the development of new products for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs, with the goal of getting important new products to patients earlier. Fast track status will also allow the company to work closely with the FDA to expedite the review of aspects of CNTX-4975 to improve the efficiency of product development.

Randall M. Stevens, MD
Randall M. Stevens

The FDA granted fast track designation to a synthetic, ultra-pure injection of trans-capsaicin for the treatment of pain linked with knee osteoarthritis, according to the drug’s manufacturer.

Centrexion Therapeutics designed CNTX-4975 for injection directly at the site of joint pain to provide rapid onset analgesia and long duration of relief among patients with moderate-to-severe osteoarthritis knee pain.

“Osteoarthritis is a rapidly escalating public health issue projected to affect nearly 67 million Americans by 2030 — it is absolutely critical that we continue to advance new pain treatments like CNTX-4975 that have the potential to relieve pain and improve stiffness and function, while avoiding the significant challenges and side effects of currently available therapies,” Randall M. Stevens, MD, chief medical officer for Centrexion Therapeutics, said in a press release. “This is an important milestone for both Centrexion and the millions of people suffering from pain associated with knee osteoarthritis.”

The FDA based its decision on efficacy and safety results from the dose-ranging 24-week phase 2b TRIUMPH clinical trial, which evaluated patients with stable, chronic moderate-to-severe osteoarthritis knee pain who failed previous oral/intra-articular analgesics.

Study results demonstrated statistically significant pain relief continuing through 24 weeks from a single 1 mg injection of CNTX-4975, as well as statistically and clinically significant improved knee stiffness and physical function during the trial in patients with moderate-to-severe knee osteoarthritis pain. Further, researchers determined CNTX-4975 to be well-tolerated with a safety profile similar to placebo.

“With the fast track approval, we look forward to additional interactions with the FDA to optimize the development of this novel, non-opioid, non-addictive pain treatment,” Stevens said in the release. “We look forward to building on the momentum of our CNTX-4975 program with the initiation of our phase 3 program in patients with moderate-to-severe knee osteoarthritis in the first quarter of 2018.”

The FDA provides fast track status to facilitate the development of new products for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs, with the goal of getting important new products to patients earlier. Fast track status will also allow the company to work closely with the FDA to expedite the review of aspects of CNTX-4975 to improve the efficiency of product development.