They'll never prescribe it

This would have more weight if they also called for the removal of generic oxymorphone and EXALGO. And since FDA has said that Opana ER (the abuse deterrent version) is easy to subvert, we should remove that, too.

FDA will NEVER take Zohydro off the market. If they did, they'd have to take off other ER opioids as well. Otherwise, Zogenix would slap them with a lawsuit a mile high, and FDA would lose, because Zohydro has met the same regulatory standard as every other ER opioid

 

....then the FDA would let the games begin by crashing through the doors to intimidate anyone who would dare prescribe Zohydro because there is more than one way to skin a cat.

 

The FDA is shaking in their boots about the slightest possibility of Zogenix going after them.

LOL

 

FDA is populated by bureaucrats who prefer to go to work and punch out at 5 PM. They don't like controversy, as it causes congressmen to poke their noses into FDA's business and prevents FDA from taking their afternoon coffee break.

FDA doesn't give a poop about Zogenix per se, but they give a whole heaping, steaming pile of poop about the regulatory mess they would incur if they pulled Zohydro and didn't do anything about oxymorphone ER and hydromorphone ER.

 

P.S.

You know who is behind the AGs sending a letter? You'll find them in Stamford.

 

"Stamford" ?????

 

East Coast. They also make chickens.

 

Oh, okay.

 

Good luck pushing this. Remember many doctors are getting leary about prescribing pain meds at all.

http://www.newser.com/story/183072/painkiller-will-kill-people-as-soon-as-its-released.html

 

This is ALL Obama's fault!

 

But they are prescribing it...

 

No you mean BUSH's fault !

 

Stolen prescription pads will make this drug a blockbuster!!!

 

What states are getting positive responses and what specialty? My docs are shutting doors on me.

 

Have been in this business a long time and bought 1000 shares today. A contrarian bet for sure given recent publicity. If your company is smart they will do two things. Concentrate on a specialty that has a definite need for this formulation, and concentrate on patients where the drug can deliver on the positive aspects of the drug. Take a measured approach until you can establish credibility. Then break out from there. And I will buy 1000 for every point you gain from 3.50. I remember laughing at JAZZ Pharmaceuticals when it was at 3 bucks and have watched it go to 161 on one product. Make money-lose money-I will have fun watching this.

 

There are a couple of PMR docs writing the hell out of it in Southern Alabama. I'd like to be that rep!

 

to the one who posted a couple docs prescribing the hell out of it in southern alabama- how are prescriptions looking right now as far as you can see? picking up month to month? how many prescriptions per territory averaging per week?

 

Nailed it! I wish I had your insight and knew this way back in January before I accepted the job offer. Should have went with another company.

 

"Q8. How many prescribers of extended-release and long-acting (ER/LA) opioid analgesics are there and what goals does FDA have for improving prescribing practices?

A. There are approximately 320,000 prescribers of ER/LA opioid analgesics in the United States, and FDA expects companies to train 25% of these prescribers at the end of the first year following implementation of the program, 50% after two years, and 60% of them within four years of the start of training. The first continuing education activities under the REMS are available to prescribers as of March 1, 2013, with others to follow."

That's from the FDA website on the ER/LA REMS. No one in this market looks at specialties. They look at prescribers. Some PCPs write ER opioids like candy. Some have panic attacks just thinking about them. You find the guys who prescribe, then present your best case. Purdue has dominated this market due to a superior product (before ADT) and formulary bullying. It no longer has that advantage. The new OC doesn't give the same pop, the pill is as big as a melon, and payers aren't afraid of patients and docs screaming for their OC. It's an open playing field, and Zogenix can get enough of the market if they are smart and very fast. The clock is ticking, but Zogenix does have a chance.

The only thing payers give a crap about is cost. If Zogenix underpriced OC a lot (and I think they have to), payers would be their best friend. Believe me, payers don't give a shit about abuse deterrence. Just cost. Zogenix needs market share, and they need it fast to get them to their new abuse deterrent formulation.