FDA approves tamper-resistant pain drug, Oxecta

July 8, 2011

FDA granted approval to Pfizer and Acura Pharmaceuticals for a new formulation of oxycodone hydrochloride (HCl) (Oxecta USP Tablets CII) that is designed to be tamper resistant, according to a joint statement from the 2 companies.

FDA granted approval to Pfizer and Acura Pharmaceuticals for a new formulation of oxycodone hydrochloride (HCl) (Oxecta USP Tablets CII) that is designed to be tamper resistant, according to a joint statement from the 2 companies.

Pfizer is expected to commercially launch Oxecta by the late third quarter or early fourth quarter of 2011, according to information about the drug on Acura’s website. According to the drug’s label, there is no evidence that Oxecta has a reduced abuse liability compared to immediate-release oxycodone. FDA is requiring Pfizer to conduct a post-approval epidemiological study to address whether Oxecta results in a decrease of the consequences of misuse and abuse, according to the regulatory filing.

Oxecta is an immediate-release drug for the management of moderate-to-severe pain. The new formulation applies Aversion Technology, which Pfizer is licensing from Acura, and is a unique composition of commonly used pharmaceutical ingredients designed to discourage opioid abuse, the companies explained. However, Oxecta can be abused in a manner similar to other opioids and narcotics-by crushing, chewing, snorting, or injecting the product. Physicians and pharmacists should consider this when prescribing or dispensing oxycodone HCl in situations where there is concern about an increased risk of misuse or abuse.

“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.”