Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

ADF Label is no joke.

Mon Jan 9, 2017 | 5:39pm EST
Egalet painkiller wins FDA approval but label disappoints
By Toni Clarke

The U.S. Food and Drug Administration on Monday approved Egalet Corp's long-acting opioid painkiller, Arymo ER, and will allow the company to claim it deters abuse by those seeking to dissolve and inject it.

However, investors had hoped the company would also be allowed to claim the drug deters abuse by those seeking to snort or chew it. That did not happen, and the company's shares fell 5 percent to $8.00 after the market closed.

A crazy day for EGLT. It seemed like trading was halted twice. Up 27% after the first halt before word spread about the label. No ADF label for snorting or chewing makes it obviously inferior to Embeda, which is the same morphine ER but with a complete ADF label (chew, snort, inject). No easy fix for this, so big news. CC going on now.

ELTP's 2 bead antagonist ADF morphine ER is a generic Embeda utilizing similar naltrexone ADF, and it will easily qualify for the complete ADF label. I predict ELTP morphine ER will be the first generic drug to be awarded an ADF label, and I wonder if the application might just be the next ANDA to be filed by Elite-- any day now.