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FDA approves tamper-resistant pain drug, Oxecta
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.”
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
