Right now EGLT and IPCI both have an NDA under review by FDA. ARYMO is Morphaine while Rexista is Oxycontin. Both are for management of sever pain with abuse deterrent properties.
ARYMO ER was first submitted in Dec 15, 2015, two and a half months later acceptance was announced In Feb 29 2016. Panel recommendation for approval was Aug 4, 2016. it's now nearly one year passed and FDA still hasn't approved it.
Our bet here is that politicians push for it, which may result in faster approval for Rexista being best in class. Let see how soon we get the acceptance letter, it may give an indication whether or not Rexista would move through the process faster. ARYMO took approximately 10 weeks for the acceptance letter.
On a side note, the goal of FDA "ADF is to eventually replace Opioid products that do not have abuse deterrent properties." This is a huge marketing potential in the next several years. And it's going to happen very fast as soon as abuse deterrent products are out and widely available, none abuse deterrent products will likely get pulled off the markets very soon.
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