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September 16, 2010

EMA har nu godkendt en ny mundopløselig smeltetablet til behandling af rejsningsproblemer

EMA har nu godkendt Levitra ® (vardenafil HCI) – en ny mundopløselig smeltetablet til behandling af rejsningsproblemer (erektil dysfunktion). I forhold til andre lægemidler i samme klasse er Levitra 10 mg det første lægemiddel til rejsningsproblemer , som kan tages uden vand. Det gør medicineringen mere diskret og nem. Tabletten opløses på tungen på et par sekunder og giver en smag af mint i munden. 
 
-          Vi stræber hele tiden efter at finde på nye og innovative alternativer til behandling af rejsningsproblemer. Som et led i dette arbejde har vi nu udviklet en mundopløselig smeltetablet, som er nem og enkel for manden at tage. Det gør det muligt for mænd med rejsningsproblemer at slippe for følelesen af at tage medicin og samtidigt kunne være mere spontan i sit seksualliv, siger Inga-Lill Hyltander, Business Area Manager hos Bayer Schering Pharma.
 
Kliniske studier med 12 ugers behandling med 10 mg mundopløselig Levitra overfor placebo, viser, at Levitra giver et statistisk signifikant flot resultat i primære og sekundære effektivitetsmålinger 1–10. I Europa påbegyndes lanceringen af lægemidlet i november 2010. I USA godkendes lægemidlet i juni 2010 og det bliver markedsført af GlaxoSmithKline og Merck & Co, Inc. under varenavnet STAXYN™.


Erektil dysfunktion
-          Cirka hver femte danske mand har rejsningsproblemer (erektil dysfunktion) i forskellige sværhedsgrader.
-          Problemet kommer oftere med alderen.
-          Trods at mange mænd lider af rejsningsproblemer er det kun få, som søger hjælp.
-          Rejsningsproblemer indebærer en vedvarende eller jævnlig manglende evne til at få eller bibeholde en tilstrækkelig erektion for sexuel aktivitet.
  
 

For mere information samt billeder, kontakt:
Hanne Bodelsen, Senior konsulent
Effector Communications
Tlf.: 3264 5400
 
Eller
 
Anna Cohen, PR Manager
Bayer Schering Pharma
Tlf.: +46 8 580 223 91
E-mail: anna.cohen@bayerhealthcare.com
 
About Bayer HealthCare
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma and as Bayer HealthCare Pharmaceuticals in the US and Canada. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide
 
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.
   
Reference
[1] Edwards, D, Hackett, G, Collins, O, Curram, J. Vardenafil improves sexual function and treatment satisfaction in couples affected by erectile dysfunction (ED): a randomized, double-blind, placebo-controlled trial in PDE5 inhibitor-naive men with ED and their partners. J Sex Med 2006;3:1028-1036.
2 Fisher, WA, Rosen, RC, Mollen, M, Brock, G, Karlin, G, Pommerville, P, Goldstein, I, Bangerter, K, Bandel, TJ, Derogatis, LR, Sand, M. Improving the sexual quality of life of couples affected by erectile dysfunction: a double-blind, randomized, placebo-controlled trial of vardenafil. J Sex Med 2005;2:699-708.
3 Giuliano, F, Rubio-Aurioles, E, Kennelly, M, Montorsi, F, Kim, ED, Finkbeiner, AE, Pommerville, PJ, Colopy, MW, Wilkins, HJ, Wachs, BH. Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury. Neurology 2006;66:210-216.
4 Hatzichristou, D, Montorsi, F, Buvat, J, Laferriere, N, Bandel, TJ, Porst, H. The efficacy and safety of flexible-dose vardenafil   (Levitra ®) in a broad population of European men. Eur Urol 2004;45:634-641; discussion 641.
5 Hellstrom, WJ, Gittelman, M, Karlin, G, Segerson, T, Thibonnier, M, Taylor, T, Padma-Nathan, H. Vardenafil for treatment of men with erectile dysfunction: efficacy and safety in a randomized, double-blind, placebo-controlled trial. J Androl 2002;23:763-771.
6 Ralph, D, Eardley, I, Kell, P, Dean, J, Hackett, G, Collins, O, Edwards, D. Improvement in erectile function on vardenafil treatment correlates with treatment satisfaction in both patients and their partners. BJU Int 2007;100:130-136.
7 Rosen, R, Shabsigh, R, Berber, M, Assalian, P, Menza, M, Rodriguez-Vela, L, Porto, R, Bangerter, K, Seger, M, Montorsi, F. Efficacy and tolerability of vardenafil in men with mild depression and erectile dysfunction: the depression-related improvement with vardenafil for erectile response study. Am J Psychiatry 2006;163:79-87.
8 Stief, C, Porst, H, Saenz De Tejada, I, Ulbrich, E, Beneke, M. Sustained efficacy and tolerability with vardenafil over 2 years of treatment in men with erectile dysfunction. Int J Clin Pract 2004;58:230-239.
9 Sperling H et al. The POTENT I randomised trial: efficacy and safety of an orodispersable vardenafil formulation for the treatment of erectile dysfunction. The Journal of Sexual Medicine.
10 Gittleman M et al. The POTENT II randomised trial: efficacy and safety of an orodispersable vardenafil formulation for the treatment of erectile dysfunction.