Thursday, May 05, 2016 9:37:53 PM
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
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.
"There are three kinds of lies: lies, damned lies, and statistics."
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