Currently, there are a host of health-related issues associated with diabetes. One specific health problem, which currently represents an unmet need, is pain associated with diabetic peripheral neuropathy. According to Daily Magazine, biopharmaceutical company Lexicon Pharmaceuticals, Inc. (“Lexicon”) is working to address this unmet need by developing LX9211, a treatment for neuropathic pain. In fact, LX9211 recently received Fast Track designation from the FDA.
LX9211
Developed by Lexicon, LX9211 is an orally-administered AAK1-inhibitor. Through analyzing and evaluating potential targets for drug development, Lexicon discovered adapter-associated kinase 1 (AAK1). Now, researchers believe this could reduce neuropathic pain in cases of diabetic peripheral neuropathy, but also in other conditions, such as Parkinson’s disease.
In preclinical studies, LX9211 successfully reduced neuropathic pain. Moving forward, Lexicon will hold a Phase 2 proof-of-concept study to evaluate LX9211 for diabetic peripheral neuropathy, as well as a Phase 2 clinical trial to evaluate LX9211 for post-herpetic neuralgia.
Fast Track status is designed to hasten the review of drugs for rare and serious conditions. According to the FDA:
Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one.
Additionally, Fast Track status helps increase communication between the FDA and drug developer, offers eligibility for Priority Review and Accelerated Approval, and allows Lexicon to submit individualized New Drug Application (NDA) sections for FDA review and approval.
Diabetic Peripheral Neuropathy
According to the Mayo Clinic, diabetic peripheral neuropathy, or distal symmetric peripheral neuropathy, is:
a type of nerve damage that can occur if you have diabetes. High blood sugar (glucose) can injure nerves throughout your body.
There are two forms of diabetes: type 1 and type 2. In both cases, the conditions are characterized by either a lack of insulin production or the improper use of insulin within the body. Because of this, patients have difficulty getting glucose out of the bloodstream and into cells. Diabetic peripheral neuropathy is one of the most common complications resulting from diabetes.
The Mayo Clinic continues that as many as half of all people with diabetes may develop diabetic peripheral neuropathy. However, pain is not present in each case. Typically, diabetic peripheral neuropathy first affects the lower extremities (legs, feet) before affecting the hands and arms. Symptoms worsen at night. These include:
- Increased sensitivity to touch
- Bone and joint pain, specifically in the feet
- Frequent ulcers and infections, often on the feet
- Muscle weakness
- Problems with balance and coordination
- Lower ability to feel pain or changes in temperature
- Numbness or tingling
