The D B Gupta-promoted Lupin has received approval from the Drugs Controller General of India (DCGI) to conduct phase-III clinical trials for its new anti-migraine compound LLL-2011, named Amigra, in the country. |
The company intends to begin the trials in at least 10 centres. The total market for migraine drugs globally is estimated to be more than $2 billion. |
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Amigra "� a botanical drug product "� is formulated as a nasal spray for use in the prophylaxis of migraine. |
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The phase-II clinical trials of this drug, which were conducted earlier, had evaluated the nasal spray in different doses. It was a multicentric, placebo-controlled, randomised, double blind, parallel group study. |
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The results of the study showed that the nasal spray was effective in the prophylactic treatment of migraine. |
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It produced significant reduction in frequency of migraine attacks and on the total pain index (TPI) of migraine in comparison to levels observed prior to treatment or levels in the placebo arm. The safety evaluation demonstrated that it was very safe and well tolerated. |
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Lupin Chairman Desh Bandhu Gupta said the company looked forward to taking this drug candidate through phase III trials and bring it to the market as early as possible. "This is a very important product for a highly unmet need and we look forward to addressing it effectively and safely," he added. |
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At present, the company has three other new chemical entities (NCEs) in various stages of clinical trials. |
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Based in Mumbai, Lupin is currently a leading pharmaceutical company with strong research focus. It has a programme for developing NCEs and it has a modern R&D centre in Pune. |
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It is also a leading global player in Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular drugs (prils and statins) and has a notable presence in the areas of diabetology, NSAIDS and asthma. |
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