Our "wonderful" OA Study

OA study can be found on www.clinicaltrials.gov. When you are on the home page search for diclofenac capsules and the first 2 studies that pop up are the Zorvolex OA STUDIES. DISASTER! Safer my ass. Then check out a study from another diclofenac product ( voltaren).
Basically same percentages meanwhile in the Zorvolex. In the Zorvolex Open label study, 99 patients dropped out due to adverse events, 46 major ones. "Doc, please put your chronic patients on Zorvolex but don't look at our study results, just the rational." GET OUT OF MY OFFICE JACKOFF!"

 

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Oh no! This outta make our Sept mtngs such a rockin good time. I might be ill. I hear a flu is coming around about this same time.

 

I agree, this company is pathetic with no launch experience or clinical data to back the product. This has been a disaster from day 1 and unfortunately we believed in these idiots. Real nice for patience that had major adverse events! Ijoko, get another investor to back the upcoming lawsuits.

 

You're an idiot and can't read the study results. In the open label study 99 of 602 patients that started reported some type of adverse event not 99 dropped out BC of AEs you loser.

Finally in the OA study the BID and TID zorvolex arms had virtually the same number of AE and lack of efficacy patients as placebo. 10, 11, and 12 out of about 100 to start for each arm. Same as placebo is pretty good to me jackass. Do you even work here? Get a life

 

Agree. The OA data looks good to me

 

Look, whoever the idiot poo-pooing the OA data. You are just wrong. It's not going to blow the doors open , but it is as solid as any safety and efficacy data for oral OA treatments out there. So with hold judgement if you have not reviewed and compared

 

That s the point you morons. Efficacy is not the issue. Doctors have prescribed diclofenac for OA before and it generally works. "As solid and any safety data" is the issue. The technology is supposed to minimize that. And if safety data is so great, why were we informed that we will be not focusing on that and more of the rational BS?

 

The rationale is safety. Don't you get it? Oh....comparative data? No, we don't have that. "Just follow me here doc!"

 

I agree, the whole point of this technology is to minimize AEs. If it is equal to other NSAIDS, then they better keep the copay program at $0.

 

How many times can you reformulate voltaren no wonder Pharma is dying!

 

Nothing's going to make you happy. We have an approval for a new indication? Great. You think a 1-year study is going to get you every safety answer every customer wants? Well, that just ain't gonna happen.

 

Okay, forget safety. Let's just talk efficacy. Anyone else seeing the simply astounding efficacy data vs placebo? So 68% achieved > 30% improvement on Zorvolex. And 50% achieved the same level of improvement on placebo! Wow! Just wow

 

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Same as other products studied in OA using WOMAC. I've sold an NSAID before. If you can't sell with this data, you can't sell. And, the goal is to similar efficacy while reducing the dose. Not better efficacy. It's maintaining efficacy but at lower dose. You're just looking as hard as you can for a reason to bitch, aren't you?

 

You really don't know what you are talking about! This was a placebo controlled trial. This a was a summary of the study "The authors reported that treatment with Zorvolex 35 mg tid “significantly improved WOMAC pain subscale scores from baseline at 12 weeks (−44.1; p = 0.0024) compared with placebo (−32.5).” Although treatment with Zorvolex 35 mg bid “provided numerical improvement in pain at week 12” compared with placebo, the results did not reach statistical significance."

After 12 weeks this drug for which wis meant for chronic use is no better than placebo. I don't know where you get from this study that it is meant to show similar efficacy with a reduced dose. If that's what they were looking for than they should have study Zorvolex versus higher strength diclofenac.

The data shows that for 12 weeks that the drug is more effective than placebo, as all other studies it says nothing about how it compares to other diclofenacs which is the major hurdle.

 

Plus the concern is not efficacy, it's safety. If you pull out PIs of other diclofenac products, you'll see there is no difference in safety which is the magical "rational" of the technology. Like I said before, as long as they keep the $0 copay, all is good. Otherwise see ya!

 

No. I do know what I am talking about thank you. Whist I am talking about is a very meager separation from placebo over 12 weeks as reported by patients in their relief of OA pain! Did it separate? Yes- is it substantial? No. Not unless you own skin in the Iroko game of "Sell this Shit"

 

Did it satisfy the FDA and the efficacy end point for approval? Yes! Will this make a difference to customers who have cheaper options? No! Will we still have to beg for business based on this data? Yes! Thanks

 

It will increase sales by 0%, if a doctor likes Z they already use it for OA, duh!!!