Dear All,Also need to understand why it was rejected, and why...

Dear All,

Also need to understand why it was rejected, and why this will help Phosphagenics.

The report also noted five deaths among the 1,512 patients who were exposed to Zohydro during clinical trials. Four of the deaths do not appear to be directly related to Zohydro ER. The one that did was a patient who hoarded Zohydro capsules and then opened and ingested them all after completion of the study.

Combination versions of hydrocodone require dosing every 4 to 6 hours, while Zohydro could be taken just twice a day, if needed. Zogenix maintains fewer doses of Zohydro would be more convenient and safer because they don’t contain acetaminophen.

“Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue,” said Stephen Farr, president and chief operating officer of Zogenix.

“However, it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen. We remain confident in the measures we have proposed to support safe use of Zohydro ER and are committed to continuing to work with the FDA through the review process to bring this treatment option to this specific patient population.”

BSW