According to their shareholder presentation last week, full results of the final phase 1 abuse potential study (oral dosing) are expected to be announced by the end of this quarter (end of march). This is where recreational users compare how much they enjoy taking the company's drug PF-614 when compared with oxycodone or sugar pill placebo.
(The first abuse potential study in recreational users was already done, and it compared crushed PF-614 with crushed oxy and crushed sugar pill placebo when inhaled through the nose. The results of the first one were terrific.)
Separately, results of part 3 (the final part) of the overdose prevention part is expected early Q3. This is where healthy (non-user) humans take a large overdose of oxycodone or PF-614 while protected by an opioid blocker drug called naltrexone, which prevents its effects. The amount of drug measured in their blood compares how big a dose they would've gotten. The first 2 parts have already demonstrated that when an overdose is taken of PF-614-MPAR (multi-pill abuse resistant), the later pills have no effect. The third part is underway, and like I said the results are expected early Q3.
Those are the two remaining phase 1 studies. Sometime between the two, the one planned phase 2 study will start. That will evaluate the speed of onset of PF-614 to demonstrate that the bioequivalence previously established between PF-614 and oxycodone also means equivalent speed of onset. Only one phase 2 study should be required since they have received FDA fast track designation.
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