Haha couldn't happen to a nicer group
Their PDUFA is October. They will have a soft launch right after approval then full launch by Jan. Simultaneously they will petition FDA to pull non abuse deterrent forms from the market. Even if not successful immediately, which they will be, prescribers will have no reason to go out on a limb for Zohydro when they have Purdue's product to safely prescribe. Sorry, just the facts.
They'll never pull it together that fast, quit being pessimistic, approval won't be till 2015 at the earliest.
Their PDUFA is October. They will have a soft launch right after approval then full launch by Jan. Simultaneously they will petition FDA to pull non abuse deterrent forms from the market. Even if not successful immediately, which they will be, prescribers will have no reason to go out on a limb for Zohydro when they have Purdue's product to safely prescribe. Sorry, just the facts.
Please review the sequence of events in spring 2013 - Purdue successful with petition to FDA to remove non abuse deterrent forms of oxy from the market. Very logical next step upon their approval in October, remove Zohydro. Perhaps Zogenix can stay on the market while waiting for their next generation product, but not many (if any) physicians will have a reason to prescribe. Zogenix will continue to reduce the company headcount as directed by the Board. Jobs will be scarce. Advise moving on ASAP.
If FDA didn't can Zohydro after the AC vote, there is no way in hell they will remove it from the market. To do so, they would have to remove Exalgo, generic oxymorphone, and immediate release oxycodone (30 mg; Roxicodone).
They will sit on the sidelines until ADT Zohydro comes out.
Exalgo has ADT in it . Also it just went generic. Keep drinking the koolaid!
Exalgo probably does have some ADT but they didn't file with it and it's not in their label.
FDA will run the clock out on Zohydro. Removing an approved opioid from the market means they have to justify leaving all the others on the market, when there's no scientific basis for singling out Zohydro.
If your curious about the ADT in Exalgo just ask your targets that write it. They all have seen the physical properties it has and human abuse liability studies. Just because it's not on the label doesn't mean it isn't there. You see in today Chronic Pain market docs actually do care about improving the safety of these drugs. That's why all of you get to look for new jobs soon!
Why is Exalgo only doing $100 mil per year if it's so whiz bang? And the trend is down.
It's feckin' hydromorphone for god's sake. Not mother's milk.