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Lyka Labs Shares Soar 7% on CDSCO Approval for Drug 

Pregabalin Gel is used to address neuropathic pain, a persistent type of pain resulting from nerve damage.

Shares of Lyka Labs Ltd soared 7% and hit an intraday high of Rs 160 on 15 October after the company announced that they have received approval from the Central Drugs Standard Control Organisation (CDSCO) for manufacturing and marketing of Pregabalin Gel 8% w/w. 

Pregabalin Gel is used to address neuropathic pain, a persistent type of pain resulting from nerve damage. The gel works by blocking the release of chemical messengers that contribute to pain and inflammation. 

In its regulatory filing, the company said, “We have developed a novel patent pending topical gel formulation of Pregabalin. 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.” 

A holistic approach is essential in treating Diabetic Neuropathic Pain, with patients frequently prescribed oral pain relievers such as Pregabalin Capsules, which have been available in India for more than 20 years, according to the company. However, the company noted that the capsules are associated with side effects. 

Lyka Labs suggested that switching to topical treatments like gels, ointments, or creams could help reduce these side effects.

During a study, 210 patients were divided into two treatment groups. One group was given the topical Pregabalin Gel, and the other group was given the oral Pregabalin Capsules for 63 days. 

The study concluded that the topical gel was well tolerated and equally effective as oral capsules in reducing pain, along with significantly lesser side effects with the gel group. 
 
At 11:21 am, the shares of Lyka Labs were trading 4.15% higher at Rs 155.62 on NSE. 

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