Company Watch

Lupin’s Amigra advances to Phase III

Our News Bureau - Mumbai

Lupin announced that it has received approval from the DCGI to conduct Phase III clinical trials for its anti-migraine compound Amigra (LLL-2011). This botanical drug product is formulated as a nasal spray for use in the prophylaxis of migraine.

The Phase II clinical trials evaluated the nasal spray in different doses. The study was conducted as a multicentric, placebo-controlled, randomised, double blind, parallel group study. The results of the test showed that Amigra is effective in the prophylactic treatment of migraine. It produced significant reduction in the 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. Moreover, safety evaluation demonstrated that the compound was safe.

Lupin intends to begin Phase III clinical trials in at least 10 centres across the nation. Commenting on the approval, Dr Desh Bandhu Gupta, Chairman of Lupin stated, "We are very excited with the approval and look forward to taking LLL-2011 through Phase III clinical trials and bring it to the market. This is a very important product for a highly unmet need and we look forward to addressing it effectively and safely." The total market for migraine is estimated to be more than $2 billion. In addition to this, Lupin has three other NCEs in various stages of clinical trials.

In yet another development, Lupin announced that the USFDA has granted tentative approval for the company's Abbreviated New Drug Application for Trandolapril Tablets, 1mg, 2mg and 4mg. Trandolapril is indicated for the treatment of hypertension.

These Trandolapril Tablets will be the AB-rated generic equivalent of Abbott's Mavik Tablets. Annual product sales of the tablets in the US were approximately $53 million for the twelve months ended July 2006, based on IMS data.