As some know, Zing is the smartest science guy here (ok, along with stockdaug). He states below that Z160 has a pretty low barrier in Phase 2 (against only a placebo), but will most assuredly be put to a much stiffer test in Phase 3, if applicable. He thinks it will be tested head-to-head against the gold standard treatments --maybe perhaps against an opioid or NSAID in LSR, and/or against Lyrica in PHN?
I don't buy it. Phase 3 will be again about efficacy (against placebo though) but mostly about safety, safety, safety. (The FDA doesn't want another Vioxx on their hands). The FDA rarely has required a drug in phase 3 to go against a known other treatment. That being said, the FDA can decide to reject a drug if they see no benefit to society over proven treatments. This will NOT be a problem with Z160. It just has to work, period. It will be up to the doctors and the marketplace to determine if it replaces morphine or maybe only just codeine.
My son recently was in a very bad accident. They gave him opioids in the hospital for almost two weeks, but after that, he's essentially received nothing of any efficacy. Everyone kept referring to the hazard of his pain meds being taken too long because of addiction probabilities. Z160 would be a godsend to us to help mitigate his high level of pain. Of course, I am assuming Z160 wouldn't be addictive, and would he would be able to take it for an extended time.
Sorry to hear about this Terry. Rather than pain meds at this point, post-hospitalization, begin to look more towards anti-spasm and antiinflammatory; these will tend to go further with the pain situation because these secondary issues are usually more the source of the pain after healing begins. What you want to do is minimize the reactive spasms and the maintenance of the self-enforcing "inflammatory soup" that slows healing, promotes spasm, and needlessly manufactures more pain. Stretching, deep muscle massage, and use of plenty of ginger, turmeric, calcium-magnesium will target this secondary injury state. Bringing a natural return of calm and reduced hyper-reactivity to a shocked system is the basic idea.
Thank you for the accolade, but I do not consider myself any smarter than others (including you) who perform DD. That being said, however, I am quite opinionated like yourself.
Anyway, I guess we will have to agree to disagree. Comparitors ARE very common in trials and not just in cancer drug development. In the Keryx trial for Zerenex, they had 3 arms to all P3 trials, Zerenex, placebo and an "Active Comparator" wherein 'Patients may receive either PhosLo..., Renvela...or a combination of these treatments' during the trial. So this study permitted doctors administering the trial to give whatever they wanted to that arm of patients. Success was measured by what was termed a "non-inferior" response of Zerenex to the active arm. Comparitors are not used when none exist i.e. see RMTI and Triferic
As for safety, please review the primary and secondary endpoints. Among the 14 defined endpoints, only ONE was designated as safety related. As for your statement, "It just has to work, period", this is quite non-specific. Aspirin and Tylenol "will work period": but neither is considered adequate for treating these illnesses. To be sure, if either of these were put through a PIII trial today for treating these diseases, do you really think they would pass muster?
Many of the PII trial endpoints are quite specific i.e.Time to a = 30% reduction in weekly average pain score; Time to a = 50% reduction in weekly average pain score; (number of) Subjects who have = 30% reduction in average daily pain score; (number of) Subjects who have = 50% reduction in average daily pain score. Such results cannot be achieved using your definition of success. These endpoints suggest a level of statistical significance must be reached. Though I cannot verify, these points suggest that if the patients fall below or outside these predefined limits, the drug "could just work" according to your definition, but still be a failure by trial definitions.
Very true. I never meant to suggest that to "just work", the data wouldn't have to be quantifiable. I just think that the other drugs for lsr and phn are not gold standards....whereas, for kidney drugs like zerenex, there are indeed specific lab tests and known therapies....
On another note, any opinion on Synta and their Hsp90 inhibitor? It could be a gold mine, but I'm getting leery of the whole concept ever since Infinity's recent hsp90 drug failure.
I actually agree with zing. I think it is very likely that Z-160 will be up against generic gabapentin in a P3 trial. The good news is that the drug doesn't have to outperform gaba; it would only need to be non-inferior.
Ranger: As per the Parkinson Center of Oregon, a major player in the conducting of phased trials, " Ph3 is used to, confirm long term effectiveness, safety and to note its less common side effects. Investigators are able to determine the drug's effectiveness compared to commonly used treatment for the disease." They don't actually say "head to head" or Gold standard. It sound s as if the comparison is against earlier empirical data ???? Hard to tell.
Jim Long and calm
Sentiment: Strong Buy