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.
You wonder if NE politicians are going to in favor of a drug that 2 percent of the would be patients tried to score the drug during the highly patient-selective trial process.
Thar do you make of the diversion numbers in this study?
Once-daily, single-entity hydrocodone (HYD) is a novel abuse-deterrent formulation under development for treatment of moderate-to-severe chronic pain. This open-label study evaluated the safety and effectiveness of HYD in long-term use in opioid-naïve and opioid-experienced subjects who had either controlled or uncontrolled pain. A total of 922 subjects received open-label HYD (20, 40, 60, 80, 120 mg/day) during the study. Of them, 728 subjects achieved a stabilized dose of HYD at the end of dose titration period (up to 45 days) and entered a 12-month maintenance period. Safety data analyzed included adverse events, aberrant drug behaviors, audiology, clinical laboratory, ECG and vital signs. Pain relief, sleep, overall function, and quality of life (QoL) outcomes were analyzed as well. Changes in HYD dose and the use of concomitant short-acting opioid and non-opioid analgesics during long-term treatment were evaluated. The treatment-emergent AEs (occurring in ≥5% subjects) included nausea, constipation, vomiting, fatigue, dizziness, somnolence, headache, typical of mu opioid agonist side effects. Suspected or confirmed abuse of study drug occurred in less than 0.5% of the subjects. Two percent of the subjects were withdrawn from the study due to suspected or confirmed diversion of study drug.
Is diversion rate for this drug going to be any better than the nonADT stuff given the fact they could not even get the abusers from diversion during the highly patient-selective trial process with only 900 patients??
On a weekly basis and q over q, fIrst 4 weeks of July ~4k the remaining 5 weeks to the end of August ~6k, 4.5 weeks to the end of the quarter and we are already roughly over the last quarter's number. Mind you we are doing a very measured and responsible marketing campaign.
~21000 up to end of August as of end of July they had ~ 15k prescriptions this makes August a ~6k script month. They said July was ~4k script month in the previous call so this is a nice month over month growth as well.
Sentiment: Strong Buy
The question is if the purdue drug needs rescue medication that contains acedominophen, does not defeat the purpose of their drug?
"Zohydro ER was developed specifically for the subset of severe chronic pain patients currently managing their pain with short-acting hydrocodone/acetaminophen medication but who need true sustained 12-hour pain relief and are at risk for acetaminophen toxicity. These data further support that Zohydro ER fulfills this medical need," said Bradley Galer, MD, chief medical officer of Zogenix. "This analysis of our pivotal Phase 3 data demonstrated that pain relief with Zohydro ER was durable throughout the entire 12-hour dosing interval without any observation of end of dose failure. This finding, coupled with the lack of the need to wake up at night to take rescue pain medication, is particularly important, since minimizing the amount of rescue medication and providing around-the-clock pain relief are often overlooked factors in the effective treatment of severe chronic pain."