Lyka Labs has received approval from the Central Drugs Standard Control Organization (CDSCO) for manufacturing and marketing its innovative, patent-pending topical formulation, Pregabalin Gel 8% w/w, indicated for patients suffering from Diabetic Neuropathic Pain. This approval follows the successful completion of Phase III clinical trials, positioning the gel as a promising alternative to oral pregabalin for pain management.
Addressing Diabetic Neuropathic Pain
Diabetic Neuropathic Pain affects approximately 50% of diabetes patients, manifesting as burning, prickling, tingling sensations, and extreme sensitivity. With India's large and increasing diabetic population, effective pain management is a critical need. Traditional oral pregabalin capsules, while effective, are known to cause side effects, prompting the development of topical alternatives.
Clinical Trial Results
A study involving 210 Indian patients compared topical Pregabalin Gel to oral Pregabalin capsules over 63 days. The results indicated that the topical gel was equally effective in relieving pain, with a significantly lower incidence of side effects. Patients using the topical gel reported substantial pain relief, and investigators expressed satisfaction with its effectiveness and safety profile.
Advantages of Topical Application
The topical application of Pregabalin offers a targeted approach to pain relief, potentially minimizing systemic exposure and reducing the risk of adverse effects associated with oral administration. This localized delivery could improve patient compliance and overall treatment outcomes. "The doctors who studied these patients were satisfied with the effectiveness and safety of topical Pregabalin Gel 8% w/w for the use in Diabetic Neuropathic Pain."
This approval marks a significant advancement in the treatment of Diabetic Neuropathic Pain, providing a well-tolerated and effective option for patients seeking relief from this debilitating condition.
