Cipla announced that the phase-3 clinical end-point study for fluticasone propionate and salmeterol inhalation powder(100/50 mcg) has been completed.
Fluticasone propionate and salmeterol inhalation powder 100/50 mcg, 250/50 mcg, 500/50 mcg are generic versions of GSK's Advair Diskus. The product is to be used to treat asthma in patients aged four years and above. In the long term, it will be used to treat chronic obstructive pulmonary disease(COPD), including chronic bronchitis emphysema or both for better breathing and fewer flare-ups.
The phase-3 study was conducted over a period of 15 months at over 100 sites in the US on 1,400 asthma patients. The results showed that the product is therapeutically equivalent to Advair Diskus. Also, there were no safety concerns identified during the trials.
Umang Vohra, MD and Global CEO, Cipla, said, “I am pleased with the successful completion of the phase-three clinical study of generic Advair Diskus. Considering the complexity of clinical endpoint study in the Fluticasone + Salmeterol combination, it is heartening to see that our study was successful in the first attempt. This is an important milestone and is a testament to Cipla’s strong respiratory capabilities, and will go a long way in strengthening our respiratory franchise in the US. Unmatched presence across the care continuum and the widest range of drug-device combinations have established Cipla’s position as a lung leader in India and other key emerging markets. Our endeavor is to extend this expertise across developed markets through niche product development.”