New Opioid Antidote Developed by OxyContin’s Maker Receives Green Light from FDA

Purdue Pharma was given the green light by the US Food and Drug Administration to accelerate the process of developing a new opioid antidote. This is despite the fact that the company is accused of fueling the current opioid epidemic that is affecting the country. Purdue Pharma’s new overdose antidote was just fast-tracked by the FDA.

The company is entangled with the deadly opioid crisis and has remained at the center of discussion for a while now. But the FDA agreed on granting Purdue Pharma’s experimental opioid overdose drug fast-track designation because it can potentially save thousands of lives.

Purdue Pharma’s drug is a nalmefene hydrochloride injection. It has a longer effect compared to naloxone, another opioid antagonist that is approved by the FDA to reverse overdoses. The FDA’s fast-track designation facilitates the development of the said experimental drug. It also expedites the review of drugs that treat serious conditions and fill an unmet medical need.

“If approved, the duration of effect of nalmefene HCl injection has the potential to serve as an important alternative for the treatment of opioid overdose,” Purdue said in a statement.

In 2017, over 47,000 US drug overdose deaths were attributed to opioids, and more than half involved synthetic narcotics, such as illicit Fentanyl. Over 70,000 overdose deaths involving drugs were reported on that same year.

“The Fast Track designation from the FDA for nalmefene HCl underscores the importance and time sensitivity of this unmet medical need. We will continue our efforts to make nalmefene HCl injection available as quickly as possible, as it has the potential to be an important option to help address this public health emergency,” said Dr. Craig Landau, president, and CEO of Purdue Pharma.

The company made it a point to mention that they will not profit from the project. Purdue said that it is committed to advancing solutions to the opioid crisis. “Purdue will not profit from nalmefene HCI.”

The Sackler family owns Purdue Pharma privately. The company is named as a plaintiff in dozens of lawsuits across the country because of its role in contributing to one of the country’s worst drug crises.

Both Purdue and the Sacklers have been accused of aggressively marketing OxyContin using deceptive sales and marketing practices. They were said to have downplayed the potentially addictive and abusive properties of the drug they were selling. Click the link to see Ann Arbor's top rehab placement programs.

The state of Massachusetts, for example, filed a complaint which argued that "From the beginning, the Sacklers viewed limits on opioids as an obstacle to greater profits. To make more money, the Sacklers considered whether they could sell OxyContin in some countries as an uncontrolled drug.”

Purdue Pharma currently seeks dismissal of the lawsuit in Massachusetts. Purdue has previously said in a statement to CNN that the accusations “irresponsible and counterproductively casts every prescription of OxyContin as dangerous and illegitimate, substituting its lawyers' sensational allegations for the expert scientific determinations of the Food and Drug Administration (FDA) and completely ignoring the millions of patients who are prescribed Purdue Pharma's medicines for the management of their severe chronic pain.”

The overdose death rate between 1999 and 2011 from prescription opioids such as OxyContin quadrupled. According to the US Centers for Disease Control and Prevention, oxycodone, hydrocodone, and methadone are among the most common drugs involved in fatal opioid overdoses. OxyContin is a brand name version of oxycodone used for severe pain.

If someone in the family is struggling with opioid addiction, it is important to seek help. A combination of medical detox and behavioral therapy can go a long way in the fight against drug abuse. But because every individual is affected by addiction differently, a comprehensive program tailored to their specific needs is necessary. Look for a nearby addiction treatment facility today and find out how drug treatment programs work.