Pain Therapeutics reports abuse-deterrence data for Remoxy ER

Pain Therapeutics Inc. (NASDAQ:PTIE) said Remoxy ER oxycodone extended release (PF-00345439) met the primary endpoint in a Phase I nasal abuse potential study. The company reiterated its plans to resubmit an NDA to FDA this quarter for the product to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.

The double-blind, four-way crossover, placebo- and active-controlled trial enrolled 38 non-dependent, recreational opioid users with a history of intranasal drug abuse. On the primary endpoint, nasal administration of both 40 mg intact and microwaved Remoxy showed significantly lower drug liking as measured by a visual analog scale (VAS) vs. nasal administration of immediate-release (IR) oxycodone (p<0.01 for both). Intact and microwaved Remoxy also met the secondary endpoints of reducing the subject's desire to take the drug again and drug high vs. IR oxycodone (p≤0.001 for both)...