Vitaros only needs prove safety with FDA
The issues of efficacy and manufacturing are resolved, see recent press releases and conference calls.
There is no safety issue with long approved alprostadil, it’s just with DDAIP, the permeation enhancer part of Vitaros. Also the carcinogenic studies on Vitaros have long been successfully resolved.
SO, only 2 things need to be addressed now with DDAIP: Safety risk to user and partner.
So what do they have to prove these 2 issues:
1. 2.5% DDAIP risk issues have been successfully addressed resulting in approvals in 23 countries in Europe, Canada, and Middle East
2. Conducted several additional supportive pre-clinical studies to address partner safety risk, see 2 studies below that posted on PubMed, not all the study work on partner safety has been posted publicly.
3. Plan on submitting post-marketing safety data from Europe on well over 1 million exposures in Europe
Urologia. 2015 Apr-Jun;82(2):84-92. doi: 10.5301/uro.5000116. Epub 2015 Mar 3.
Clinical efficacy and safety of Vitaros©/Virirec© (Alprostadil cream) for the treatment of erectile dysfunction.
Int J Toxicol. 2015 Jan-Feb;34(1):11-5. doi: 10.1177/1091581814561870.
Daily application of alprostadil topical cream (Vitaros) does not impact vaginal pH, flora, or histology in female cynomolgus monkeys.
Meier-Davis SR1, Debar S2, Siddoway J3, Rabe M3. |
