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Lyka Labs shares rally 7% on CDSCO nod for diabetic neuropathy pain drug

Lyka Labs shares rose as the company announced that it has received the CDSCO approval for manufacturing & marketing of of Pregabalin Gel 8% w/w for use in patients with Diabetic Neuropathic Pain.

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SI Reporter New Delhi

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Lyka Labs share price: Pharmaceutical company Lyka Labs shares were buzzing in trade on Tuesday, October 15, 2025, as the scrip flew up to 6.78 per cent to hit an intraday high of Rs 159.70 per share. 

The uptick in Lyka Labs share price came after the company announced that it has received the Central Drugs Standard Control Organisation (CDSCO) approval for manufacturing and marketing of Pregabalin Gel 8 per cent w/w for the use in patients with Diabetic Neuropathic Pain. 

Pregabalin gel is designed to address neuropathic pain, which is a persistent type of pain resulting from nerve damage. Its mechanism involves blocking the release of chemical messengers that contribute to pain and inflammation.
 

Lyka Labs, in a statement 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 comprehensive approach is crucial for managing Diabetic Neuropathic Pain, with patients often prescribed specific oral painkillers like Pregabalin Capsules, which have been available in the Indian market for over two decades, the company revealed. However, these capsules are known to cause side effects, it added. 

Lyka Labs claimed that transitioning to topical applications such as gels, ointments, or creams may help mitigate these side effects.

In an Indian study involving 210 patients, participants were divided into two treatment groups where one received the topical Pregabalin Gel, while the other was treated with oral Pregabalin Capsules for 63 days. 

The study found that the topical gel was well tolerated and equally effective as oral capsules in alleviating pain, with significantly fewer side effects reported for the gel. Most patients indicated substantial relief from pain after using the topical formulation, and the treating doctors expressed satisfaction with its effectiveness and safety.

India ranks among the top two countries globally with a rising number of diabetes patients. Over time, nearly 50 per cent of individuals with diabetes develop symptoms associated with Diabetic Neuropathic Pain, including burning, prickling, tingling sensations, electric shock-like feelings, aching, tightness, or extreme sensitivity to light touch.

Lyka Labs is a pharmaceutical company renowned for its expertise in Sterile and Topical Preparations. Based in Mumbai, its research and development (R&D) centres are dedicated to developing a diverse array of New Formulations and innovative Drug Delivery Systems, with a focus on Lyophilized Injectables and Topical Preparations.

At 9:56 AM, shares of Lyka Labs were trading 4.35 per cent higher at Rs 156.05 per share. In comparison, BSE Sensex was trading 0.10 per cent lower at 81,889.57 levels.


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First Published: Oct 15 2024 | 10:03 AM IST

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