You don't get it, according to the article both the control group and the drug groups had access to 6 doses on IR medication. Therefore if the majority of the drug group as well as majority of the control group took the rescue medication the drug is an utter failure because despite the superior analgesic effect of the drug group, the fact that they needed rescue medication with APAP, defeats the purpose of the drug and the drug would not be approvable for its APAP-free indication. Now if not majority, but a good portion of the drug group required rescue medication, if drug approved by the FDA, there would still be a need for zohydro ER in the market place because the patients on zohydro don't need rescue medication.
If the purdue drug requires rescue medication that contain APAP, doesn't that defeat the purpose of the drug?
The article I am reading says the patients were allowed to use up to 6 doses of rescue medication of 5m oxycodone per day. Can someone who have an access to the trial papers tell us if it is true?
The fact that the drug does not sell has no thing to do with the CEO, he already has 190 people in the commercial organization and the drug has already gotten so much publicity that every patient and doctor already knows about it. As far as I am concern even if gets rid of all of his sales staff, the drug will continue to sell at the current pace just because of the awareness caused by the media.. The fact is the drug itself has a limited market potential. Perhaps because there are not too many patients with bad livers at least not yet. Assuming they got 1225 perscrptions (as reported by someone on this board) on the second week of September it is not too hard to surmise that the scripts will grow over time and probably plateu around 3k prescriptions per week some times next year so they just have to adjust the cost structure to that run rate and focus on the other drug.
Dear Zohydro-ban activists, I see twitter is abuzz with all of the frustrated doctors and pharmacists about the hydrocodone becoming schedule 2 drug. I also found one character by the name of Lewis Nelson MD who sided with Shumer on Zohydro ban, now it is interesting he has had a change of heart and tweeted an article that says rescheduling to class 2 is not likely going to stop abusers and shady pharmacies! I challenge you zohydro-ban activists, I know you mean well, after Oct 6, just count how many politicians will switch sides, in order to return hydrocodone to schedule 3. You will soon find out which doctors and politicians that were once outspoken activists against zohydro ER and the addiction epidemic are and have been in the pockets of big pharma all along. Go ahead start with the north eastern states, in particular keep an eye on the New England states, which are big pharma back yards. This rescheduling is a major blow to big pharma, and pharmacy chains, which have been profiting from the sale of tons of hydrocodone in everything from pain meds to cold and cough meds.
Zohydro is not selling all that well, the rate of growth of the prescriptions signals of a limited market size. Lets say you ban this and you get 200 prescriptions out of tens of thousands of Hydrocodone prescriptions off the market every day, 99.9% of which by the way have no ADT. At the end what did you accomplish? There is a small market for Zohydro and frankly those are the patients that need it real badly because they have bad livers and have no other options. All you will be doing is taking it away from the people that will end up dead with bad livers who would need liver transplants if the take APAP. Zohydro is already as good as banned so don't waist your effort. If you want to ban something look at purdue's portfolio, PFE's portfolio and Mylan's porfolio, Teva etc. etc. etc. They are the ones who are making the real bucks in pumping out tons of Hycrocodone every day. So march on in Washington and scream real loud, we are all behind you and want to reduce the number of addicts, but keep in mind you really are going about it the wrong way.
It looks like we are %15 of the way there after 24 weeks.
If the politicians had any idea how hard it is to sell this stuff they would lay off.
This quarter they will likely lose 25 million and their cash will likely be down roughly the same amount down to 56M
.The question is whether a 24 hr dose temptation by itself negates any effort at tamper resistance and draws the abusers to the drug. Furthermore what explanation does purdue has for attracting so many abusers to the study. Was there a screening process problem? Did someone on the inside helping the abusers in? All of these questions need to be vetted out, IMHO, after all in a small study such as this they must have screened the subjects to the nth degree before letting them in. The real world is going to be much less forgiving.