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Pfizer blocks dosing products for adults until they receive devices, which also contain strict warning label
The US Food and Drug Administration will not permit the use of opioid drugs such as OxyContin among adults until it receives a device used in a crucial overdose-prevention trial, reports say.
Pharmaceutical companies are already required to sell opioids in a medical device format under an FDA policy that was designed to reduce the availability of the drugs in non-medical settings.
The new policy, meant to reinforce that non-medical drug use is risky, was among the factors that prompted Pfizer to temporarily block sales of its medications for adults through its website, the Associated Press reported.
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The devices, known as auto-injectors, contain a tube of metal with a device you stick into the side of your thigh to deliver a drug.
The dosing method is one of two main methods of delivering a drug, the AP said. The other forms is by injecting a pill into your arm.
The first-of-its-kind US trial involves 23,000 users who use a combination of the auto-injectors and a pill for a treatment that is designed to block hydrocodone from a patient’s opioid receptors, the AP said.
The opioid epidemic caused by prescription drug use and the illegal drug trade will likely continue to put tremendous strain on public health resources, experts say. Nearly half of all drug overdose deaths involve opioids.
But the study, which began enrolling patients in August, has not found a difference in overdose risks when the drug is delivered with the auto-injector versus the other method, the AP said. The most recent number is roughly 270 people in the trial, who received the auto-injector and had an overdose death rate of about twice that of those who also received the hydrocodone-only pill, the AP said.
Pfizer officials could not be reached for comment.
Pfizer runs the clinical trial for the FDA and manufactures the auto-injectors.