Lupin gets CDSCO panel nod for phase III trial of Formoterol Fumarate, Budesonide FDC
New Delhi: Pharmaceutical major, Lupin has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) for conducting phase III clinical trial of Fixed Dose Combination (FDC) of Formoterol Fumarate 12mcg and Budesonide 400mcg inhaler, which is used to successfully treat asthma symptoms and improve lung function.
The approval came after the firm presented the revised Phase III Clinical trial protocol before the committee. The revised phase III protocol was made in line with the earlier SEC recommendation dated 03.12.2020 where the drug maker, Lupin, was directed to revise and submit the phase III protocol of FDC of Formoterol Fumarate and Budesonide by clarifying the following points:
1. Dose equivalency of DPI and MDI needs to be presented for the suitability of the proposed comparator.
2. In the previous protocol, the sample size was not justified, and the power of the study was also insufficient.
3. COPD is one of the indications proposed by the firm, but that protocol did not include such a patient population.
4. The firm has included investigators in the study without obtaining their consent or undertakings, which must be clarified.
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