Sun Pharma Advanced Research Company Ltd. (SPARC) has announced that its SPARC DPI salmeterol 25 µg/fluticasone propionate 50 µg dry powder inhaler failed to show bioequivalence to Seretide Accuhaler (Advair Diskus) salmeterol 50 µg/fluticasone propionate 100 µg in a pivotal study because the peak concentration of salmeterol for patients using the SPARC DPI was higher than the peak concentration of salmeterol for Seretide.
The 50 µg fluticasone propionate component of the SPARC DPI did show bioequivalence to Seretide’s 100 µg fluticasone propionate in the randomized single dose crossover PK study which enrolled children and adults with asthma, adults with COPD, and healthy volunteers.
All participants were able to use the device successfully, and mean peak inspiratory flow data and safety profile were comparable between the study arms.
SPARC CEO Anil Raghavan commented, “The results confirms that our device is highly efficient and consistent in delivering more drug to the lungs and suitable for all classes of patients. We will consult the regulatory agencies in Europe to understand the potential path forward for SPARC DPI.
Read the SPARC press release.
