Diabetes directly impacts millions of Americans, and the condition could almost be considered a global pandemic by its own right. Having persistently high blood sugar levels causes many problems within the human body. One of the most prevalent issues is diabetic peripheral neuropathic pain and the condition is estimated to hit more than 3 million people annually in America alone.
While current treatments can help manage this painful condition, there is currently no known cure. Help could be on the way for millions of Americans sooner rather than later. A Woodlands, Texas-based biotech outfit named Lexicon Pharmaceuticals, Inc., via an alliance with drug-maker Bristol-Myers Squibb, has some potentially promising news for those who are suffering from diabetic peripheral neuropathic pain.
Lexicon’s LX9211 has received a Fast Track designation from the Food and Drug Administration (FDA) as a potential treatment for diabetic peripheral neuropathic pain.
Lexicon announced that it is currently enrolling patients suffering from this neuropathic pain in a Phase 2 proof-of-concept study. The company is also still preparing to launch a second Phase 2 clinical trial of LX9211 in post-herpetic neuralgia.
A Fast Track designation does not at all imply that a drug will definitely be granted FDA approvals, but having a Fast Track designation for serious conditions and unmet medical needs significantly lowers the time to bring important new drugs to patients. If studies are positive, the designation also makes programs eligible for accelerated drug approvals and priority reviews. And while this means saving time and money for the companies involved in studies, it can also mean a faster availability and potentially better drug prices for patients.
Full details of this Fast Track designation can be found in the company’s press release, but a prior release from Lexicon Pharma had indicated that results for both LX9211 studies are expected by the end of 2021. It is possible that this Fast Track designation could speed that timeline up, but that would depend upon many factors that are not yet known. That prior release also indicated that its trial enrollment will cover approximately 300 patients from 30 U.S. clinical sites.
One of the key issues that has played a role in treating diabetic peripheral neuropathic pain has been the pain-killer and opioid crisis in America. LX9211 is an oral treatment that is a selective small molecule inhibitor of adapter-associated kinase 1 where preclinical studies were shown to demonstrate central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways.