Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Kempharm fails to acquire ADF label.



Here's why:





Kempharm was applying for a Category II ADF label based on the above PK graphs of KP201. Intranasal KP201 is orange line and hydrocodone is blue line.

https://www.sec.gov/Archives/edgar/data/1434647/000156459015008097/kmph-ex991_6.htm

Data from the KP201.A03 intranasal human abuse liability trial, which was designed to compare the amount of hydrocodone released from KP201 and from hydrocodone bitartrate (HB) (both without APAP) after insufflation, demonstrated a statistically significant reduction in Cmax, a delay in Tmax, and a significant decrease in total exposure to hydrocodone especially at early time points typically associated with increased drug liking, abuse and safety. Secondary endpoints related to drug liking, pupillometry and ease of snorting also showed significant differences between KP201 and HB, with KP201 demonstrating lower drug liking, less pupil dilation and higher difficulty of snorting than HB.

They were not given ADF label because it is a crappy ADF. It somewhat decreases Cmax and delays Tmax and also showed "significant difference in drug liking." But they never show a drug liking curve in any presentations, nor do they provide any actual data (which means it is not impressive).


In contrast, this is what the drug liking curve looks like for what will be the first-ever immediate-release opioid to receive Category II ADF label.





Shows Mean Drug Liking on Visiual Analog Scale (VAS). Time is on horizontal axis. On the verticle axis, anything above 50 means they liked it, below 50 they disliked it. Notice the expected liking of snorted oxyIR (green). ELI-200 (blue) is actually *disliked* at the outset- see how the blue line falls below the placebos (red & yellow). For some reason, drug abusers disliked snorting it, as opposed to feeling neutral, like snorting the placebo. And ELI-200 never bumps above the placebo line, indicating the naltrexone effect is long-lasting.