Karessa Pharma Holding AB announces today that the last patient is dosed in the company's clinical study with K-03 Vardenafil buccal film
The final dose of healthy volunteers in Karessa's clinical trial with K-03/1 buccal film is now performed and the study will be completed as planned today, the 15th of December 2017.
The study is a Phase I, open, randomized, single-center study on healthy male subjects in order to determine the PK profile in the body (pharmacokinetic profile) of Vardenafil given as K-03/1 buccal film. The study consists of comparing the PK profile of four different variants of K-03/1 buccal film. Except for the evaluating of PK profile, the safety and tolerability of Karessa's K-03/1 buccal film has also been investigated.
The study comprises a total of 16 male volunteers with a goal that at least 12 completing the entire study. Now when the dosing is complete, it can be noted that all 16 volunteers completed the entire study and all except for one person has received all doses. The study has also proceeded without any serious side effects and the side effects that have been registered have been mild and of a kind that is well known for Vardenafil.
Final results from the study will be reported in the beginning of April 2018.
FOR MORE INFORMATION, PLEASE CONTACT:
Michael Brobjer, CEO, Karessa Pharma Holding AB (publ)
Tel: +46 8-768 22 33
About Karessa Pharma Holding AB
Karessa develops new pharmaceuticals based on a patented drug delivery technology and proven pharmaceutical substances in order to offer men with impotence problems a fast and more reliable effect. Karessa is listed on Nasdaq First North and has Remium as Certified Advisor.
About Karessa's pharmaceutical projects for treatment of erectile dysfunction
Current treatment of impotence is well proven and has a favorable safety profile, but many patients are bothered by the delayed onset and that it may vary depending on food intake. These problems are a consequence of the drug being given as tablets and thus has to pass the stomach and liver before reaching the right place in the body.
Karessa has developed a buccal film with Vardenafil (K-03). The film is small and is placed on the inside of the chin where it dissolves as the drug is delivered directly into the bloodstream via the oral mucosa. By this way the drug is delivered into the body and a quick and reliable onset is achieved. This completely regardless of whether you just have been eaten a good dinner.
Impotence affects many middle-aged men and has an increased prevalence of age. The global market for impotence drugs is estimated to a value of approximately SEK 35 billion.
For more information, please visit karessa.se