To: BMcV who wrote (1422 ) 11/15/1998 11:13:00 PM From: Biomaven Read Replies (1) | Respond to of 10280
Bruce, I took a look at the SEPR web site presentation of the (S)-oxy study. Not a whole lot more detail than the release, but you can get to see some pretty graphs. Looking at the data they released and poking around for data on straight oxy and Detrol, it seems this efficacy data is in the same ballpark as them, and the side-effects are definitely better than oxy and probably comparable to Detrol. All the studies are plagued by a big placebo response, which makes it much harder to show efficacy. All the oxy reports bemoan its side-effects and the high drop-out rates that stem from them. So it seems to me that (S)-oxy is most likely a viable drug, albeit not a blockbuster. Here is some comparable info on Detrol (from the PNU press release announcing its approval):In the largest clinical development program for a bladder control medication (almost 2,000 adult patients with symptoms of overactive bladder), Detrol (2 mg twice daily) effectively reduced the median number of times people urinated over a 24-hour period. In three placebo-controlled, 12-week studies with Detrol (2 mg twice daily), patients had a significant reduction (15 to 21 percent) in median number of urinations per 24 hours compared to baseline (baseline median ranged from 10.4 to 11.0 urinations per 24 hours). This reduction was significantly greater than the change for placebo-treated patients. Data from three placebo-controlled studies showed that patients taking Detrol (2 mg twice daily) decreased their incontinence episodes by 50 to 56 percent from baseline. This reduction was not statistically significant compared with placebo. The overall number of adverse events with Detrol was comparable to placebo. Reported side effects of Detrol considered treatment-related included dry mouth (39.5 percent for Detrol vs. 15.9 percent for placebo), headache (11.0 percent vs. 7.4 percent), constipation (6.5 percent vs. 4.5 percent), indigestion (5.9 percent vs. 1.7 percent), and dry eyes (3.8 percent vs. 1.7 percent). Discontinuation from the studies due to side effects was also comparable to placebo (8.0 percent with Detrol vs. 5.7 percent with placebo). Detrol should not be used in patients with urinary retention, gastric retention and uncontrolled narrow-angle glaucoma. Notice that Detrol, even in a big study, didn't show significance compared with a placebo for number of incontinence episodes. (S)-oxy was on the cusp of significance (p=.053) (week 2, higher dose) in a much smaller study. Peter