(144) Routes of administration of tapentadol products as reported to poison centers

Abstract

Tapentadol immediate-release (NUCYNTA) was launched in June 2009 with the extended-release product (Nucynta® ER) released in August 2011. Tapentadol is a centrally-acting analgesic with μ-opioid receptor agonistic and norepinephrine reuptake inhibition activities. In an effort to deter abuse, particularly through unintended routes of administration, the extended-release tablets were manufactured using Intac® technology to be difficult to crush for intranasal abuse and difficult to solubilize for intravenous abuse. Cases classified in the Intentional Exposure category in the Poison Center Program of the Research Abuse, Diversion, and Addition-Related Surveillance (RADARS®) System were analyzed and used to test whether the proportion of cases reporting use via injection or inhalation is lower for extended-release tapentadol than for immediate release (IR) tapentadol. Between the launch of the extended-release product and June 2015, there were 303 Intentional Exposures involving ER tapentadol and 217 Intentional Exposures involving IR tapentadol. Of the 303 ER tapentadol intentional exposures, 178 (58.8%) were classified as Suspected Suicides and 47 (15.5%) were Intentional Abuse exposures. Of all ER tapentadol exposures, 5 (1.7%) of the 303 exposures reported use via injection or inhalation, all of which were Intentional Abuse exposures. Of the 217 IR tapentadol cases classified as Intentional Exposure, 55.8% were Suspected Suicide exposures and 14.3% were Intentional Abuse exposures. Ten (4.6%) of these exposures reported use via injection or inhalation. Of these, 8 were Intentional Abuse exposures, 1 was Suspected Suicide, and 1 was Intentional Misuse. The proportion of tapentadol ER exposures mentioning injection or inhalation use is significantly lower than the proportion of IR tapentadol exposures (χ2=3.95, p=0.047). Though intentional exposures still exist, extended-release tapentadol is associated with fewer incidents of injection or inhalation use in cases reported to the RADARS System poison centers. Supported by a research grant from Depomed, Inc.