Can FDA-approved Journavx Put An End To Death From Opioids?

Of the many things FDA approved and banned, the latest on the list is Journavx, a new type of painkiller that does not carry the risk of addiction or overdose associated with opioid medications. This is the first new class of pain medicine approved by the FDA in more than 20 years.

Jacqueline Corrigan-Curay, the acting director of the FDA's Center for Drug Evaluation and Research in a statement said, "Today’s approval is an important public health milestone in acute pain management. A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.”

Why Is The Approval Important?

This approval is considered a major breakthrough in treating acute pain without the need for opioid medication as reliance on such medications could lead to addiction. As per the Centers for Disease Control and Prevention (CDC) data, more than 81,000 people in 2023 died in overdoses which involved opioids.

What Are Opioids?

Opioids are used to treat pain, cough, and diarrhea. They can be used to treat pain from an injury, illness or surgery. As per National Institute on Drug Abuse (NIDA), opioids are a class of natural, semi-synthetic, and synthetic drugs. Natural opioids include morphine, codeine, opium and thebaine, semi-synthetic opioids include heroin, oxycodone, hydrocodone, and oxymorphone, whereas synthetic opioids include fentanyl. NIDA also mentions that it can be highly addictive, if misused and can cause breathing difficulties, and overdose could also lead to death. These medications can also cause tolerance, physical dependence and opioid use disorders.

As per the World Health Organization (WHO), the term "opioids" includes compounds that are extracted from the poppy plant as well as semisynthetic and synthetic compounds with similar properties that can interact with opioid receptors in the brain. WHO also notes that in 2019, about 600,000 deaths were causes worldwide due to drug abuse, among them, 80% of the deaths were related to opioids, whereas 25% were caused by opioid overdose.

What happens when you overdose on opioids:

• Pinpoint pupils
• Unconsciousness
• Difficulties with breathing

Journavx and how it works

As per FDA, Journvax "reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain." It is different from opioids, as they bind to the receptors in the brain that receive nerve signals from the body.

The newly approved medicine also showed a "statistically significant superior reduction in pain" when compared to a placebo in two randomized trials, said FDA. However, it did not outperform a common opioid-acetaminophen combination pill.

However, the advantage of the newly approved drug is not its efficacy but the side effect profile, which also includes the absence of addiction potential. The medicine will cost $15.50 per pill, which is more expensive than comparable opioids.

Does it have any adverse reaction?

As per FDA, the common adverse reactions in the study for Journavx, the participants experienced itching, muscle spasms, increased blood level of creatine phosphokinase and rash.