Shares of Pain Therapeutics, Inc. (NASDAQ: PTIE) skyrocketed nearly 150 percent, at the time of writing, reaching $11.20. The company reported positive results today from a human abuse potential study of its late-stage drug candidate, REMOXY.
REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation of oxycodone. The proposed indication for this drug candidate is for "the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate." We developed REMOXY to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients. In particular, REMOXY's thick, sticky, high-viscosity gel-cap formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking.
Study results indicate that in non-dependent, recreational opioid users, nasal administration of REMOXY resulted in significantly lower abuse potential compared to immediate-release (IR) oxycodone. All study subjects reported reduced ‘Drug Liking’ ‘Take Drug Again’ and ‘Drug High’ for REMOXY compared to oxycodone IR. In addition, nasal administration of REMOXY showed lower exposure to oxycodone, lower peak concentrations (Cmax) and longer time to peak drug concentration (Tmax) against comparator drugs, suggesting comparatively lower abuse potential.
As a result, the company plans to resubmit the REMOXY NDA to the FDA shortly. “We believe these data indicate REMOXY may have limited nasal abuse potential relative to comparator drugs,” said Remi Barbier, President & CEO. “We have now successfully completed all studies necessary to resubmit the REMOXY NDA to the FDA, and plan to do so shortly.”