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PharmacoFore, Inc. Announces Positive Results from a Phase I Clinical Study of Its Hydromorphone Bio-Activated Molecular Delivery™ System, and Upcoming Presentation at the 2011 BIO Business Forum During the Annual BIO International Convention in Was
Date:6/23/2011

on of existing opioid drugs in physical matrices that are easily circumvented by simple extraction methods.  PF329's pharmacokinetic profile appears optimal for twice-daily dosing.  

The Phase I study was a single-center, dose-escalation and fixed-dose crossover, cohort study to determine the safety and pharmacokinetics of a single oral dose of PF329 in healthy subjects. Fifty-one healthy volunteers received oral doses of PF329 in solution ranging from 1 – 48 mg, and 12 received immediate release HM in approximately molar-equivalent doses.  The objectives of the study were to assess the safety, tolerability, and pharmacokinetics of PF329, as well as the pharmacokinetics of its pharmaceutically active moiety, HM.  The secondary objectives of the study were to identify appropriate doses of PF329 for subsequent clinical studies and to evaluate the effects of food on the pharmacokinetics of PF329.  HM exposures were independent of the fed / fasted state of the subjects.

Dr. Lynn Webster, a world leader in pain management and prescription drug abuse, explained, "PharmacoFore's Bio-MD™ system not only resists abuse via injection and inhalation, but, importantly, the most common method, which is oral abuse. As the Phase 1 study demonstrates, crushing or chewing will not affect the extended release profile of the delivery system. Further, unlike any other product on the market or in development, combining the Bio-MD™ and MPAR™ technologies will remove the incentive to abuse by consuming multiple pills, and protect against oral overdose."

According to Steven Passik, PhD, Professor of Psychiatry and Anesthesiology, Vanderbilt University Medical Center, "New and innovative abuse-deterrent technologies are greatly needed in our efforts to continue to treat pain and take reasonable and responsible steps to prevent abuse and diversion."

"We believe these data provide objective evidence of the viability o
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SOURCE PharmacoFore, Inc.
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