Durect (DRRX)

[Youlie]

Here's a lil more of a tidbit. Makes me understand why adcom was cancelled

PAIN THERAPEUTICS ANNOUNCES POSITIVE TOP-LINE RESULTS FROM HUMAN ABUSE POTENTIAL STUDY WITH REMOXY
REMOXY Meets Both Primary Endpoints with Statistical Significance (p < 0.0001)
AUSTIN, Texas, May 12, 2015 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc., (Nasdaq:PTIE) today announced top-line results of an FDA Category 3 Human Abuse Potential Study with REMOXY Extended-Release Capsules CII, its lead drug candidate that is specifically designed to discourage certain common methods of drug tampering and misuse. This study demonstrated with statistical significance (p < 0.0001) that both intact and chewed REMOXY were less "liked" than immediate-release oxycodone on the two primary endpoints, Drug Liking and Drug High. The Abuse Potential study was conducted in non-dependent, recreational opioid users, as recommended by FDA guidelines.
"We believe today's results demonstrate abuse-deterrent properties of the REMOXY formulation against a common, and often lethal, form of oral drug abuse," said Nadav Friedmann, PhD, MD., Pain Therapeutics' Chief Medical Officer.
Study Design
Pain Therapeutics' former corporate partner for REMOXY had sole responsibility for this FDA Category 3 Human Abuse Potential Study with REMOXY. This study was conducted in accordance with draft FDA Guidance to Industry on Abuse Deterrent Opioids and interactions between the study sponsor and FDA. The study was randomized, double-blind, placebo and active controlled, using a 4-way crossover design in healthy, non-dependent recreational opioid users. Nearly 60 subjects completed this study, with an average age of 27 years. The study's primary objective was to measure the abuse potential of chewed and intact 40mg REMOXY compared to 40mg immediate-release (IR) oxycodone when taken orally. Study subjects were instructed to chew REMOXY capsules vigorously for up to 5 minutes, but none were able to do so in light of REMOXY's high viscosity, texture or taste. Pharmacodynamic measures of the primary endpoints, Drug Liking and Drug High, included use of a standard 0-100 point Visual Analogue Scale (VAS) in the initial two hours post-dose (AUC02h), as recommended by FDA to assess a formulation's abuse potential. The sponsor generated study tables for this Abuse Potential Study in December 2014. Pain Therapeutics has not performed an independent analysis of study results.
Top-line Study Results
Clinical and statistical highlights include:
On the co-primary endpoint of Drug Liking, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0001) compared to IR oxycodone.
On the co-primary endpoint of Drug High, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0001) compared to IR oxycodone.
On the secondary endpoint of Good Drug Effects, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0001) compared to IR oxycodone.
On the secondary endpoint of Bad Drug Effects, scores were significantly higher for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0079) compared to IR oxycodone.
On the secondary endpoint of Pupil Constriction, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0001) compared to IR oxycodone.
On the secondary endpoint of Nausea, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0143) compared to IR oxycodone.
On the secondary endpoint of Feel Sick, scores were significantly lower for intact REMOXY (p < 0.0002) and for chewed REMOXY (p < 0.039) compared to IR oxycodone.
"We believe results of today's study speak to the clinical and commercial potential of REMOXY," said Remi Barbier, President & CEO of Pain Therapeutics. "REMOXY's high viscosity is intended to deter injection and snorting. We believe this feature, coupled to today's data on oral abuse, contributes to an overall assessment of abuse potential that supports a label-claim for REMOXY."

http://www.biotechnologyevents.com/node/6987