Elite Pharmaceuticals Inc (ELTP)

[rrr2003]

No. . .I disagree. Nasrat knew of the Tmax being affected by a fatty food meal but was given guidance by the FDA that this could by remedied by a labeling warning. This is all detailed in the CC conducted after the CRL was issued in July/2016.

He really messed that whole thing up. Not knowing the people eating food would impact the results. Cmon

https://s3.amazonaws.com/sec.irpass.cc/2258/0001144204-16-113802.pdf

In our meeting with the FDA in November of 2014, Dr. Hertz requested three extra studies:an efficacy study (a Bunionectomy),an anti-abuse study and a BE study - sorry, it was a withdrawal study and a BE study. We indicated that we know that there is a food effect on our product so why are we doing another BE study for fed? FDA clearly stated that this is not a pass or fail, it’s a BE for labeling issue. We complied and we ran the study. We ran a three armed study: SequestOx fed intact, the capsule with a fatty meal; SequestOx sprinkled on applesauce with a light meal - bagel cream cheese, yogurt and applesauce - over 400 - 500 calories - and the brand. The fatty meal,as expected, showed that we are bio-equivalent for the AUC and Cmax but not the Tmax. For the light meal we were bio-equivalent for all three; AUC, Cmax and Tmax.

Let me very quickly summarize, when you’re on SequestOx against the brand on fasted conditions we are bioequivalent for AUC, Cmax,and Tmax. When you compare SequestOx in the fed condition using a light meal - a agel,cream cheese, yogurt and applesauce - that’s sprinkled we are also bio-equivalent under AUC, Cmax and Tmax. When you compare SequestOx under fed conditions - a fatty meal, the brand and SequestOx are bio-equivalent for AUC and Cmax but not Tmax. What that means is that there’s a delay in getting the effect. We also ran 163 patients in a Bunionectomy that met all its primary points. The Bunionectomy was critical in that these patients ate wherever they fed them at the hospital or the clinic and they went home and ate whatever they wanted for the remainder of the week. The results were successful and we met all of our primary end points.

Historically,again, with this tremendous success and a small effect from the food it would have been a labeling issue where you instruct the patients to take the drug an hour before a meal or two hours after a meal. As a matter of fact that was the FDA’s stand when we met with them in 2014. FDA today believes that this is a safety issue and this is exactly what they told us and I’m quoting from the FDA’s complete response letter: “The extent of the delay in the absorption and peak concentration of oxycodone from SequestOx under the fed conditions is unacceptable as it places patients at risk of unintentionally overdosing” the FDA goes on to say because the proposed indication is for acute pain and the product is to be taken as needed product
labeling with a specific food recommendation cannot fully mitigate this risk”.