Asensio has some very loose criteria for what passes for his DD when it comes to science. He apparently considers a Letter (not a peer reviewed study) published in the Lancet to be proof of non-efficacy, whereas studies published as peer-reviewed, in the NEJM, apparently have no credence.
This Italian "study" involved hanging a two pound weight from the erect penis of an impotent man after MUSE and seeing if it buckled. If it buckeled under this strain, it was deemed, "not rigid". The same study showed 100% of the same subjects had enlargement and increase in blood flow after MUSE.
But this is what Asensio said:
NEW YORK, Dec. 10 /PRNewswire/ -- Asensio & Company today issued the following:
<<A study of 123 impotent men treated with Vivus' Muse product at the Centre for Impotence and Fertility in Rome, Italy found that Muse failed to make 121 of the penises rigid. This test's endpoint was very different than Vivus' 1996 study, which used an "Erection Assessment Scale." This is a baldfaced lie, intercourse was the endpoint for the Vivus studies, see the NEJM study below The Italian study actually measured the rigidity of each penis and concluded that the penises were not hard.>>
Summary of studies from the VVUS web site:
The efficacy of MUSE was demonstrated in the largest prospective clinical study conducted in organic erectile dysfunction to date. At 58 U.S. sites, 1,511 patient couples were studied. These patient couples had a 48-month mean duration of erectile dysfunction (at least 3-month history of no erections without medical assistance) and a patient age of 61.6 years. 66% of patients successfully completed in-clinic titration and achieved an erection sufficient for intercourse. Not all patients beginning titration had a successful dose and some patients could not tolerate MUSE, primarily due to penile pain.1
Those patients who responded during the in-clinic phase were eligible for and continued on to home-treatment. During the home-treatment phase, 65% of men achieved successful intercourse at least once compared to 19% on placebo.1 In patients who responded to MUSE during the home-treatment phase, 7 out of 10 administrations resulted in successful intercourse.1
MUSE was well tolerated by patients in clinical trials. Only 7% of patients during in-clinic dosing and less than 2% of patients during home treatment discontinued therapy primarily because of adverse events.
During an in-clinic evaluation (N=234), patients rated MUSE easy to administer.
REFERENCES: 1. MUSE Package Insert, VIVUS, Inc. and N.Engl.J.Med. 1997; 337:1-7 2. Data on file, VIVUS, Inc. 3. NIH Consensus Statement - Impotence. 1992;10(4):1-33. 4. Feldman HA. Impotence and its medical and psychosocial correlates: results of the Massachusetts male aging study. J Urol. 1994;151:54-61.
N Engl J Med 1997 Jan 2;336(1):1-7
Treatment of men with erectile dysfunction with transurethral alprostadil. Medicated Urethral System for Erection (MUSE) Study Group.
Padma-Nathan H, Hellstrom WJ, Kaiser FE, Labasky RF, Lue TF, Nolten WE, Norwood PC, Peterson CA, Shabsigh R, Tam PY
BACKGROUND: Erectile dysfunction in men is common. We evaluated a system by which alprostadil (prostaglandin E1) is delivered transurethrally to treat this disorder. METHODS: Alprostadil was delivered transurethrally in a double-blind, placebo-controlled study of 1511 men, 27 to 88 years of age, who had chronic erectile dysfunction from various organic causes. The men were first tested in the clinic with up to four doses of the drug (125, 250, 500, and 1000 microg); those who had sufficient responses were randomly assigned to treatment with either the effective dose of alprostadil or placebo for three months at home. RESULTS: During in-clinic testing, 996 men (65.9 percent) had erections sufficient for intercourse. Of these men, 961 reported the results of at least one home treatment; 299 of the 461 treated with alprostadil (64.9 percent) had intercourse successfully at least once, as compared with 93 of the 500 who received placebo (18.6 percent, P<0.001). On average, 7 of 10 alprostadil administrations were followed by intercourse in men responsive to treatment. The efficacy of alprostadil was similar regardless of age or the cause of erectile dysfunction, including vascular disease, diabetes, surgery, and trauma (P<0.001 for all comparisons with placebo). The most common side effect was mild penile pain, which occurred after 10.8 percent of alprostadil treatments, but the pain rarely resulted in refusal to continue in the study. Hypotension occurred in the clinic in 3.3 percent of men receiving alprostadil. Hypotension-related symptoms were uncommon at home. No men had priapism or penile fibrosis. CONCLUSIONS: In men with erectile dysfunction, transurethral alprostadil therapy resulted in erections in the clinic and in intercourse at home.
Nice Try, Asensio, but the investors here are a little better informed than you expected. Not that I think Asensio has any more power to move this stock than a flea fart in a wheat field.
Zebra |
