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NEW YORK — Pfizer Inc. and Acura Pharmaceuticals Inc. have received approval from the Food and Drug Administration to market the pain reliever Oxecta Tablets CII.
The companies said that 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, which Pfizer is licensing from Acura, is a unique composition of commonly used pharmaceutical ingredients, according to the drug makers.
Oxecta is indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.
Pfizer and Acura noted that opioid medications are a key 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.
"We recognize our responsibility to physicians and patients and remain committed to appropriate access to pain treatment and developing medicines to potentially address this important public health and safety issue," stated Olivier Brandicourt, Pfizer president and general manager for primary care. "Oxecta will further expand Pfizer’s presence in pain management and complements our growing, robust portfolio of treatments and medicines in development for pain relief, one of our strategic, high-priority disease areas. We are pleased to bring Oxecta to patients and physicians with our partner Acura.”
Robert Jones, interim president and chief executive officer of Acura, commented, "We are excited to be partnered with Pfizer to bring Oxecta to patients who need opioids to manage their pain. Acura is focused on developing technologies that are intended to potentially deter abuse and misuse."
