According to a preliminary review by the U.S. Food and Drug Administration (FDA), Pfizer’s long-acting opioid painkiller might be resistant to deter abuse. Consumers can still extract oxycodone from the experimental drug by using certain solvents.
The treatment is intended to be called Troxyca ER, and it has been designed with some properties to avoid abuse. Because opioids are commonly used while reducing pain, patients with severe pain might sometimes misuse this drug, what has caused latest high rates of death due to the overdose of this medication. Hence, the abuse-resistant properties of this drug will be released in the case that patients crushed the drug’s pellets in an attempt to abuse the painkiller.
Opioid drugs contain oxycodone, an analgesic to treat moderate to severe pain. The mechanism to block the misuse of this component is composed by naltrexone. Naltrexone is a drug used to counteract the effects of opioids (oxycodone), which will be incorporated into the pharmaceutical product pellets.
Pfizer aims to market the drug for those patients who need around-the-clock treatment doses for severe pain, but also it will be useful for those who cannot relieve pain with other drugs.
On Monday, the review by the U.S. Food and Drug Administration (FDA) was published to show how the experimental long-acting opioid painkiller from Pfizer has the potential to deter abuse. The disadvantage of this experimental drug is that it seems that patients can still extract oxycodone from Troxyca ER by the use of multiple conventional solvents, some of them are more easily to get than others, according to the review.
#FDA Qs for $PFE #Troxyca (#oxycodone ER) mirror those for $TEVA #Vantrella (#hydrocodone). Approve? Which routes to claim abuse deterrence?
— SAC Tracker (@FDAadcomm) June 6, 2016
Reviewers have said that little amounts of oxycodone are released when Troxyca ER is heated. This will prevent the abuse of this medicine using inhalation.
On June 8, outside experts will discuss the drug’s properties, and they will decide if the disposal should be approved. There is a precedent linked to the approval of an abuse deterrent drug in 2014. Embeda is the name of another long-acting painkiller also from Pfizer, which has been approved by FDA with a similar technology of the one used by Troxyca ER.
Meanwhile, Pfizer has said that there is only one way (using one single solvent) to extract oxycodone without the opioid antagonist, naxeltrone.
Nowadays, the United States have alarming rates of abuse of opioids. According to the Centers for Disease Control and Prevention (CDC), 78 Americans die every day from opioid overdose.
Source: FDA