• One describes an analysis of real-world data regarding the risk of unintentional exposures in children less than six years old to NUCYNTA ER, other extended release (ER) opioids and/or IR opioids and found that the risk of serious adverse events per gram of opioid dispensed for other ER opioids was 4 times higher than for NUCYNTA ER.
• The second reports 36 instances of intentional abuse and misuse exposures in the U.S. involving NUCYNTA ER and 526 instances for non-abuse deterrent formulation (ADF) ER opioid tablets/capsules and found that non-ADF ER opioid tablet/capsule cases were more than two and a half times more likely to involve tampering than NUCYNTA ER. None of the NUCYNTA ER cases resulted in a major medical outcome or death among intentional abuse and misuse cases, compared with 13% for non-ADF ER opioids.

• The poster “Comparison of Pharmacokinetics and Simulated Driving Performance Healthy Volunteers Taking Therapeutic Doses of Gastroretentive Gabapentin, Gabapentin, or Pregabalin” describes a double-blind, placebo-controlled, crossover study of 28 healthy volunteers to determine the relative impact of Gralise, gabapentin, and pregabalin on both daytime function—assessed by driving simulator performance— showed that greater impairment was observed for the primary driving endpoint for gabapentin and pregabalin than for Gralise, reaching statistical significance. Neurological symptoms, such as tremor and visual disturbances were seen at a lower frequency for Gralise than gabapentin, with less frequent adverse events for Gralise versus gabapentin, and pregabalin, a difference which may reflect Gralise’s distinct pharmacokinetic profile.
  
  
• The poster “Updated and Validated Comparison of Plasma and Cerebrospinal Fluid Fentanyl Pharmacokinetics and Bioavailability When Delivered Intranasally or Sublingually” presents data from a partially randomized, open-label, three-way crossover, single-center study comparing two transmucosal formulations of fentanyl (Lazanda nasal spray and Subsys® sublingual spray) in 13 healthy subjects shows that systemic fentanyl exposure was numerically higher when administered intranasally versus sublingually, while the exposure to fentanyl’s primary metabolite, norfentanyl was lower.