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Lexicon Pharmaceuticals selects Medidata to promote first non-opioid drug in two decades for diabetic nerve pain

Medidata's technology will improve patient experience, accelerate clinical trials and streamline research management

Diabetic neuralgia. Illustration: depositphotos.com
Diabetic neuralgia. Illustration: depositphotos.com

Medidata, a brand of Dassault Systèmes and a leading provider of clinical trial solutions to the life sciences industry, has been selected by Lexicon Pharmaceuticals to help advance PROGRESS, a phase II study of LX9211 in diabetic neuropathic pain (DPNP) with the potential for LX9211 to become the first non-opioid drug approved for neuropathic pain above from two decades.

Lexicon will use Medidata's DCT (Distributed Clinical Trials Program) solutions, which combine artificial intelligence and automation to remotely manage real-time data from patients in the real world, regardless of where the patient is in their treatment journey.    

"Our technology is changing the way clinical trials are conducted and managed. It improves the patient experience, and it helps the development and approval of new treatments, faster than ever before", said Anthony Costello, CEO of Medidata. "We are proud to work with Lexicon and promote this innovative treatment for diabetic nerve pain, a treatment that may improve the lives of patients suffering from this condition."

According to the Mayo Clinic, diabetic neuropathy is a complication of diabetes that can affect up to 50 percent of patients with this chronic disease. Currently, existing treatments rely on opioids, which can have severe side effects, including addiction, to relieve pain. "After more than two decades, no new non-opioid drugs have been approved, we are excited about the potential of LX9211," said Craig Granowitz, MD, Ph.D., senior vice president and chief medical officer, Lexicon. "We are at a critical juncture in our efforts to make this drug available to diabetic patients suffering from nerve pain, and our partnership with Medidata cannot be overstated in the contribution of our collaboration with Medidata to accelerating this trial and recruiting our first patients for PROGRESS."

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