Pfizer and Acura Announce FDA Approval of Oxectatm (Oxycodone HCL, USP) CII

Pfizer Inc. PFE and Acura Pharmaceuticals Inc. ACUR announce the marketing approval from the U.S. Food and Drug Administration (FDA) of OXECTATM (oxycodone HCl, USP) Tablets CII. OXECTA is indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate. OXECTA is the first immediate-release oxycodone HCl medicine that applies technology designed to discourage common methods of tampering associated with opioid abuse and misuse. This AVERSION® Technology is a unique composition of commonly used pharmaceutical ingredients. Pfizer is licensing the technology in OXECTA from Acura. Opioid medications are an important treatment option for patients with moderate to severe pain who are not adequately managed by other pain treatments. However, abuse and misuse of opioids is a serious public health issue that is the focus of a number of recent United States government initiatives.