In a press release last week, Purdue Pharma L.P. announced that the US Food and Drug Administration (FDA) approved Hysingla ER (hydrocodone bitartrate) extended-release tablets CII, a once-daily, single-entity medication formulated using Purdue’s proprietary extended-release solid oral platform, RESISTEC™. According to the release, it is the first and only hydrocodone product to be recognized by the FDA as having abuse-deterrent properties that are expected to deter misuse and abuse via chewing, snorting, and injection.
The company notes that the newly approved medication does not contain acetaminophen, the overuse of which has been reported to be a leading cause of acute liver failure in the United States. Prescription products containing hydrocodone and acetaminophen are both the most prescribed and among the most widely abused (nonmedical use) medications in the US. The release further notes that potential for abuse of Hysingla ER by the intravenous, intranasal, and oral routes still exists.
Read the press release from Purdue Pharma, including commentary from PAINWeek senior faculty member Charles Argoff, MD, here.