KemPharm seeks FDA approval for hydrocodone substitute drug
KemPharm Inc. today announced that it has submitted a new drug application with the U.S. Food and Drug Administration for its abuse-resistant, immediate-release version of the painkiller hydrocodone. If priority review by the FDA is granted, approval could take place as early as the third quarter of 2016, the Coralville-based company said in a release. KemPharm’s proposed new drug — a form of hydrocodone combined with acetaminophen and which only becomes activated after being ingested — is designed to deter certain common methods of abuse and has shown the potential to limit excessive opioid exposure in patients and non-medical users compared with other drugs.