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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?


To: F. Jay Abella, III who wrote (2062)1/27/1998 6:26:00 PM
From: Claud B  Read Replies (1) | Respond to of 7041
 
Are you suggesting that Zonagen should make every detail of their formulation available to the public and their potential competitors?

That doesn't sound like good business practice now, does it?

ClaudB



To: F. Jay Abella, III who wrote (2062)1/27/1998 8:44:00 PM
From: Dr. Voodoo  Read Replies (2) | Respond to of 7041
 
What the heck I'll give it a go again.

>>At what time points did phentolamine produce erections?
>>How much phentolamine did it take to produce this effect?
>>Were the results statistically significant versus placebo?
>>Was there any noted toxicity?

You know about the endpoints for the pIII trial, you should know about the reported trial outcome. No other (relevant to this discussion) questions were asked by that trial.

Real hard PK data is another story. Get the international patent application if you don't have it already and make your own determination as to whether or not they(Zonagen)are holding a few cards. I think you should be able to afford a lousy $4.95. I think the address is micropat.com

>>Did the drug or any of its metabolites accumulate in patients?
>>Were any of the metabolites found to produce adverse effects?
>>If so, is there a metabolite profile and whendid the AE's occur?

I would suspect from my limited amount of reading that all that has occurred is that the absorption profile of the drug as changed from being absorbed sometime after dissolution of the pill(26.33 minutes average in the patent application) to immediately. I don't know whether or not this would change the distribution or toxicity profile of this drug. My guess is NO. I will not go into the reasons behind the guess. It is unlikely that it would change the type of metabolites.

Of interest, I have been looking for any PK papers on phentolamine. I have had difficulty in finding them(other than the Imhof studies). I have inferred from a De Bros and Wolshin paper that somebody was going to do a study, but I can't find it. Anybody seen a PK study of this 45 year old drug that doesn't have Imhof stamped accross it? I would be surprised if this data isn't somewhere.

Rob