Lyka has received the CDSCO approval for manufacturing and marketing of Pregabalin Gel 8% w/w
Lyka has developed a novel patent pending topical gel formulation of Pregabalin which has been approved by CDSCO.
After extensive research and successful completion of the Phase III Clinical Trials, Lyka has received the CDSCO approval for manufacturing and marketing of Pregabalin Gel 8% w/w for the use in patients with Diabetic Neuropathic Pain.
Pregabalin Capsules are known to cause side effects. One approach to overcome side effects of oral drugs used for pain relief is to use their topical applications such as gel, ointments, or creams.
India is considered to be amongst the Top 2 countries in the world with a rising number of diabetes patients. Over a period of time, almost 50% of patients with diabetes develop symptoms such as burning pain, prickling pain, tingling, electric shock–like feeling, aching, tightness or extreme sensitivity to light touch. This is called Diabetic Neuropathic Pain.
The most effective way to treat Diabetic Neuropathic Pain is a comprehensive approach and patients are often prescribed specific oral pain killers such as Pregabalin Capsules, which have been available in the Indian Market for over 2 decades.
In the Indian study, 210 patients were divided into two treatment groups. One group was treated with topical Pregabalin Gel while the other group was treated with oral Pregabalin Capsules, for a period of 63 days. On completion of the study, it showed that topical Pregabalin Gel was well tolerated by the patients and was equally effective as oral Pregabalin Capsules in relieving pain. The side effects were significantly lower in topical Pregabalin Gel in comparison to oral Pregabalin Capsules.
Majority patients reported significant relief from pain after the use of topical Pregabalin Gel. 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.
Subscribe To Our Newsletter & Stay Updated