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Pfizer And Acura Announce FDA Approval Of Oxectatm (Oxycodone HCL, USP) CII

Pfizer Inc. (NYSE: PFE) and Acura Pharmaceuticals Inc. (NASDAQ: ACUR) announce the marketing approval from the U.S. Food and Drug Administration (FDA) of OXECTA TM (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.

“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.”

Important Safety Information

OXECTA is contraindicated in patients with respiratory depression in unmonitored settings and in the absence of resuscitative equipment, in any patient who has or is suspected of having paralytic ileus, in patients with acute or severe bronchial asthma or hypercarbia, and in patients with known hypersensitivity to oxycodone, oxycodone salts, or any components of the product.

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