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 Two percent of the subjects were withdrawn from the study due to suspected or confirmed diversion of study drug.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."
This statement seems to indicate that zohydro did not have this problem during the phase 3 study and the post hoc study:
Here is the excerpt from their press release:
“Long-term Safety and Effectiveness of Once-daily, Single-entity, Abuse-deterrent Hydrocodone in Chronic Nonmalignant and Nonneuropathic Pain: Results of a Long-term Open-label Study”
W. Wen, L. Taber, S. Yu Lynch, E. He, C. Munera, S. Ripa
This study, with a 52-week maintenance-treatment period involving 922 patients, evaluated the safety and persistence of analgesic effect of HYD in both opioid-naïve and opioid-experienced subjects with moderate to severe chronic nonmalignant and nonneuropathic pain. HYD was generally well tolerated, with the most common treatment-emergent adverse events being those typically associated with the use mu opioid analgesics, and no unanticipated safety concerns were identified. Comprehensive audiologic testing did not reveal any ototoxicity associated with HYD. During maintenance HYD treatment, persistence of analgesia and improvement in function were achieved with stable HYD doses. Short‐acting opioid use was stable at a reduced level from screening baseline during the 52‐week HYD treatment period.
Does this mean patients had to use short acting opioids despite 24 hour dosage? What does the last sentence mean?
I think this guy is the key to the war against Zogenix. The timing of the arrival of his alias is the start of all of the political nonsense and misinformation against zohydro. He could be orchestrating this fraud. Someone on fierce pharma suggested he maybe AC from PFE. Can SEC expose this guy? In his last diatribe he is threatening the doctors who prescribe Z, and that ain't right.
This guy is operating under this fake name (Scruffy Fitch) for about 5 months and all of his comments in all news sources is against zohydro and Zogenix. He pretends to have been a pain patient on morphine who somehow cured himself and his mission in life is to make Zohydro a schedule 1 drug. He even makes disparaging remarks about Zo management, and their salaries and Z cash position, which is even more surprising because he claims to gave no financial interest in his mission. He claims to have started companies and sold them one of which is supposedly a fortune something company. For someone so successful he has time for long verbose diatribes and all against Z. Can anyone expose this guy?
Drugcite reports 17 deaths were reported as a direct result of mifepristone from 2004 to 2012, lord knows how many died as an indirect result of that drug in a drug combination etc. Of course that goes without saying million of babies also died. If they succeed in getting zohydro off the market you can bet your booties southern states will attempt to ban RU486.