Adamis Pharmaceuticals Corporation recently announced promising outcomes from the pharmacokinetic assessment of its beclomethasone dipropionate HFA product APC-1000 for asthma and COPD. This study was a Phase I, randomized, open label, single-dose, four-way crossover pharmacokinetic evaluation comparing the company’s APC-1000 (Beclomethasone Dipropionate HFA, 80 mcg Inhalation Aerosol) to Teva Respiratory, LLC’s Qvar® (Beclomethasone Dipropionate HFA, 80 mcg Inhalation Aerosol).
A total of 22 healthy male and female individuals were enrolled. The study included a screening period prior to cohort randomization and the four treatment periods, separated from each other by a minimum of 3 days. The two Inhalation Aerosols were given to each subject for a total dose of 320 mcg BDP (corresponding to 4 inhalations). 21 individuals completed the study; 1 of the individuals was removed from the study due to non-compliance.
The goal of this pharmacokinetic study was to compare APC-1000’s bioavailability to the bioavailability of Qvar®. The results show that the degree of absorption of APC-1000 is equivalent to that of Qvar®.
Dennis Carlo, CEO and President of Adamis stated in a press release: “Based on the study conclusions and the extent of PK similarities between APC-1000 and Qvar®, we predict that our drug (APC-1000) will be as safe and efficacious as Qvar®. We expect that this will be confirmed in an upcoming Phase III study initiated this year in which we will compare APC-1000 and Qvar® for non-inferiority.”
APC-1000 is an ahydrofluoroalkane (HFA), inhaled, oral steroid, branded generic formulated to address asthma and COPD. Adamis Pharmaceuticals is using an accepted, well-known steroid and combining it with an HFA propellant in order to make a pulmonary metered dose inhaler (pMDI) with potential to become an internationally top-selling product. Adamis believes that the product development risks inherent for this product are low once this product is well documented and has been well accepted.
Notes About Adamis Pharmaceuticals Corporation
Adamis Pharmaceuticals Corporation is a bio-pharmaceutical company developing and marketing products to address therapeutic areas that include respiratory disease, allergy, immunology and oncology.
In other developments on asthma, a team of researchers funded by the National Institute of Biomedical Imaging and Bioengineering led by David Beebe, Ph.D., Director of the Microtechnology, Medicine, and Biology lab at the University of Wisconsin, developed a handheld device to diagnose asthma from a single drop of blood by assessing a specific feature of neutrophils that differs between in asthmatic and non-asthmatic patients. In asthmatic patients, Neutrophils migrate to the lungs when other cells of the immune system within the lung tissue become stimulated and begin to release type of proteins called chemokines.
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