Karessa K03 vardenafil via buccal film

Vardenafil belongs to a group of medicines called phosphodiesterase type 5 inhibitors. They are used for the treatment of erectile dysfunction in adult men, a condition that causes difficulty in obtaining and retaining erections and affects to a greater extent more than one in ten men. Vardenafil only works with sexual stimulation, reducing the effect of the natural substances that hinders erection. Vardenafil is a more modern variant of PDE 5 inhibitors with a relatively low risk of side effects. In 2018, the patent for vardenafil expired, which has so far been sold as an approved drug in tablet form under the name Levitra®, but now more generics enter the market.

Karessa's project K03, vardenafil based on the patented trans buccal drug delivery platform allows the patient to receive vardenafil in a new form of administration, absorbing the substance from the oral mucosa and into the bloodstream. The patient thus receives a safe, quick and effective treatment of the problems. The Karessa K03 project is also patented, and the case is expected to enter public phase in 2019.

Project K03 has been reformulated in 2018 and results from preclinical studies have been published. Comparison between Vardenafil, Karessa and vardenafil tablet in the corresponding dose shows that the important pharmacokinetic values (Cmax and AUC) are within the limits of approval of the drug administration authority.

These results should be confirmed in human clinical regulatory studies. Karessa is now working on agreements with international partners regarding the implementation of these studies and later commercialization. In collaboration with AdhexPharma SAS, development of regulatory batches of Vardenafil, Karessa, has been initiated.


Last updated May 15, 2019