Vardenafil, Karessa, project K03, in erectile dysfunction into a new development phase
Karessa has now finalized the reformulation of project K03, Vardenafil, Karessa, a decision made spring 2018.
The development has been documented in preclinical studies. A comparison between Vardenafil, Karessa, and vardenafil tablet in corresponding doses resulted in Cmax(maximum plasma concentration) the ratio 0.91 and for AUC (Area Under the curve) 1.03. These are the essential pharmacokinetic parameters for pharmaceutical registration and in comparison, to reference (tablet), the values should be within ±20% limit (the ratio 0,8-1,2)
The company will now enter next phase in further negotiations with international partner with the objective to in cooperation implement the regulatory clinical studies, which then will be initiated during 2019.
This information is information that Karessa Pharma Holding AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 12.30 CET on 13 May 2019.
For more information, please contact:
Mats Nilsson, VD Karessa Pharma Holding AB (publ)
Tel: +46-8-768 22 33
About Karessa Pharma Holding AB
Karessa is a Swedish pharmaceutical company with the goal of developing products based on a patented drug delivery platform with direct absorption of active substances from the oral cavity to the bloodstream. For more information, visit karessa.se. Certified Advisor: FNCA Sweden AB, firstname.lastname@example.org, +46-8-528 00 399.