Replies to post #3928 on Repros Therapeutics Inc (RPRX)

[marthambles]

<the FDA going to consider a drug treatment like Proellex to be more lifestyle (given the 'benign' alternative) than really medical necessary or a valid choice?>

I assume you are limiting this query to fibroids. I can assure you that nobody would consider an effective non-surgical treatment for endometriosis to be a "lifestyle choice."

[dewophile]

"From the fact that 1/3 of US women have had at least a partial hysterectomy by the time they are 60 it sounds like the medical establishment views the procedure as pretty benign"

i think it speaks more to the frequency of problems associated with uterine disease and lack of viable medical alternatives. hysterectomy is not a trivial procedure. it's certainly a bigger deal than tonsillectomy. it has more morbidity than an appendectomy. it is and should be thought of as a major abdominal procedure. an open case takes probably on average 1.5 hours, 2-3 day hospital stay, pain requiring narcotics, and a *6 week* recovery. it has a non-trivial rate of complications like wound dehiscence (just like other abdominal cases), and most gyns don't go through a career without at least one more serious complication like bladder, bowel or ureteral injury
bottom line - it's far from "benign"


"what safety the FDA will require? - directly or obliquely"

i have no idea beyond what the company has stated and has already been discussed on this board. I can add what i think the safety requirement *should* be - like any proper risk benefit assessment, the risk of the drug shoudl be weighed against the alternatives, and in this case the alternatives are invasive - so the bar should be set appropriately. adn as i have said before, the alternatives for bad endo is a life of pain, a revolving door of surgery, chronic utilization of opiates, and the bar should be somewhat different in this indication (although with this risk averse fda i doubt that will be the case)

"is it going to hit prescribing docs in the pocket book?"

good question. i'm sure there are docs that rely on surgery for a significant slice of their income, but more and more surgery is a money-losing proposition given current reimbursements. you can make mroe money per unit time in the office - in teh case of proellex endometrial monitoring with ultrasound and/or biopsy is probably a better finanical proposition at the end of the day. regardless pt demand and good practice will drive demand