To: Tunica Albuginea who wrote (5470 ) 2/15/1998 4:46:00 PM From: MissLil Read Replies (1) | Respond to of 23519
Don't know anything about this particular drug, but transdermal (across the skin) drug applications are a hot area of drug development today. No reason to think it won't work, IMO. Similar successful drugs include EMLA cream and other topical anesthetics. Recently someone in our hospital coated a man's finger with EMLA cream, then did extensive surgery on the finger 30 minutes later, without any additional anesthesia! I'm too chicken to try that, but it was reliably reported to me by several RNs. One problem with topical alprostadil might be absorption by the partner with resulting side effects. For those willing to use condoms, might not be a problem. Incidentally, saw an interesting angiogenesis abstract recently suggesting that local alprostadil may improve penile circulation by increasing angiogenesis (growth of new blood vessels) in the penis. I had good intentions to copy the abstract but never found the time. If anyone is interested, go to Pubmed and search using "angiogenesis" and "nitric oxide" or "penis." On other controversies: there is almost always some overlap in stimulation of receptors by drugs or ligands in the same family. The overlap can be measured by various types of studies of binding, or by functional assays. I tried one evening for about an hour to find these types of studies and could not (they may not be in the medical data bases, or I may have been to tired to find them). However, this type of data would be most helpful in determining whether the serious side-effects associated with PDE-III inhibitors might be associated with off-label high dose use of Viagra. Most drugs that I have reviewed in depth have more data available in the literature than Viagra does. Usually at least animal studies are available. The fact that one or two studies will be published after approval is not reassuring to me and doesn't help in predicting the value of this product. Although the next advisory committee meeting is reported to be in April, I would not rely on the advice that therefore the product approval will be delayed until May. If the application (for Viagra) was submitted in October, as I guess, and if this product is on fast-track approval, also a guess, then the FDA will try to make a decision by 6 months after the submission date. There are mechanisms for getting advisory opinions that don't require a full meeting. Criteria for fast-track approval include drugs for which there is a lack or dearth of acceptable therapeutic options and new molecular entitites. Probably other things that I don't know about. Viagra good to go on both counts. Bottom line, expect Viagra approval in March or April IMO.