It has come to health officials’ attention nationwide that there is a serious rise of abuse of painkillers, especially opioids. Federal officials recently stepped up plans to monitor frequent prescribers and users.
In what could provide a potential boost to those efforts, an oxycodone drug designed to deter tampering — altered so the pill is less easily abused — has received approval from the Food and Drug Administration, Pfizer and Acura Pharmaceuticals announced Monday.
This new formulation is a redesigned drug, an immediate-release form of oxycodone called Oxecta that will be less readily abused than traditional forms of oxycodone. But the tablet has several safeguards built in to frustrate someone trying to inject or snort the pills, such as causing an uncomfortable burn in the nasal passages. The immediate-release medication contains niacin, which is designed to cause uncomfortable flushing and skin irritation if a person takes more than the recommended amount.
The drug isn’t the first form of oxycodone designed to discourage tampering. It joins an extended-release formulation of OxyContin approved last year. But the FDA points out the drug are not completely tamper proof. It said, “The new formulation of OxyContin reduces the likelihood that this drug will be misused and abused, although it cannot completely eliminate this possibility.”
Oxecta shouldn't be used in people who have severe asthma, upper-airway obstruction or chronic obstructive pulmonary disease (COPD), drug makers Pfizer and Acura Pharmaceuticals said in a news release. Common adverse reactions include nausea, constipation, vomiting, headache, itchiness, insomnia, dizziness and lack of energy, the authorities said.