The FDA's Historic Caution On Abuse Deterrent Labeling

Before the market open on Friday, IntelliPharmaCeutics Intl Inc (USA) (NASDAQ: IPCI)reported its NDA submission for its abuse-deterrent Rexista (oxycodone hydrochloride) extended release tablets designed in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.

"The NDA submission of Rexista® represents a critical milestone and turning point for the Company,” said IntelliPharmaCeutics CEO Dr. Isa Odidi. “This is our first NDA submission and the first abuse-deterrent oxycodone product candidate we are aware of that not only resists common forms of abuse but provides a preventive tool that may flag early warning of abuse.”

After the announcement, shares of IntelliPharmaCeutics are up around 9 percent in early trading.

FDA Pattern Of PDUFA Date Delays

Abuse deterrent labeling is still relatively new for the FDA. Their final guidance on the matter was issued in April 2015.

“Since then, there has been a continual refinement and evolution of label language as abuse-deterrent products get approved,” said Cantor Fitzgerald analyst Chiara Russo in an October research note addressing the FDA’s delayed PDUFA goal date for Egalet Corp (NASDAQ: EGLT)'s Arymo.

Supporting Evidence

The analyst cited historic cases of Zohydro (2013), Hysingla (2014) and Xtampza (2015), all of which saw delayed PDUFA dates with eventual approval, to support her thesis.

"If you look at historically at this point, the FDA has hit a pattern with these opiods coming to market, and it's not a bad thing," said Russo in a PreMarket Prep appearance on October 14. "It just seems like the process of getting an opiod through the FDA just requires a lot more boxes to be checked."

The analyst expects FDA approval for Egalet’s Arymo by the end of 2016.

At Last Check

• Egalet was down 4.49 percent at $7.45.
• IntelliPharmaCeutics was up 4.33 percent on the day at $3.13.