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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: Cacaito who wrote (4389)	1/13/1998 11:01:00 PM
From: MissLil	Read Replies (1) \| Respond to of 23519

re: articles on phentolamine and phenoxybenzmine. Thanks for cc:ing these articles to me. The first article (Gwinup, Ann Int Med 7/15/88 (old article!)) 16 patients, within patient control, 1/2 with active drug first, 1/2 with placebo 1st. Patient population: "could not achieve an erection for 3 months or longer" Instructions: take phentolamine (dose not stated), 1.5 hr before attempted intercourse. Criteria for success: successful penetration and ejaculation. Results (combined): phentolamine 11/16; placebo 3/16. Impression: Well designed study with statistically and clinically significant results but would need to be repeated with larger numbers. Second study: Zorgniotti, Int J of Impotence Res 6:37-41, 1994. Patient population: "inability to maintain erection, without ejaculation, upon initiation of vaginal penetration (mean time of impotence: 3.4 yr, range 0.5 to 35). Pts with "extreme penile vascular insufficiency" excluded (not clear to me exactly how this was defined). Trial 1: 98 pts; within subject control, unblinded Phentolamine HCL 50 (red) vs. phenoxybenzmine 10 mg po (white) taken 1.5 hr before attempted coitus. Excluded unevaluable pts (bad policy, although they had relatively high included numbers - I've added them back in) phentolamine: full 36/98 (37%); Partial: 15%; No: 35% Phenoxybenzamine: full 9/98 (9%); Partial: 5/98 (5%); No: 74(76%) Well, this looks different to me, but what did you expect, everyone KNOWS that red pills are stronger than white pills! Seriously, there does seem to be a difference here. It is totally unreasonable to remove people for the stated reasons. Why did so many more pts "lose" their pills for the one that didn't work? In this case, it actually makes the comparison better. Trial 2: Buccal phentolamine vs. placebo 30 min prior to intercourse. Phentolamine 22 0.265060241 full:27% ; partial 11%; none:46%; Placebo: full 11%; partial 2%; none 70% There are a lot of things that I don't like about these studies (the last article especially). However, they are consistent and do support the proposition (no pun intended) that phentolamine is effective either buccally or orally. Of course larger and more properly designed studies would be needed to support this. I suspect that the phentolamine patent has expired, which could make it difficult to support a commercial application. Do you know? I was unable to get online with SI for several days, therefore the delay.