Pfizer Inc. and Acura Pharmaceuticals Inc. announce the
marketing approval from the FDA of OXECTA (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(R) 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
“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,” said Olivier Brandicourt, Pfizer president and general manager,
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.” “We are excited to be partnered with Pfizer to
bring OXECTA to patients who need opioids to manage their pain,” said
Robert Jones, interim president and chief executive officer of Acura Pharmaceuticals,
Inc. “Acura is focused on developing technologies that are intended to
potentially deter abuse and misuse.”