FDA approves Vertex non-opioid pain drug
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The FDA's approval of the non-addictive painkiller Journavx last week marked a milestone in the field of pain management.
Why it matters: Millions of Americans with acute and chronic pain are prescribed opioids, which are effective but carry the risk of abuse and addiction.
Driving the news: Journavx, from Vertex Pharmaceuticals, is first new class of acute pain medicine in more than 20 years.
- It was approved for adults with moderate to severe pain and has a list price of $15.50 per pill, or $31 a day.
- Journavx works by blocking pain signals in the nerves, not in the brain or its reward pathways. That provides relief without the addictive qualities of opioids.
What they're saying: "People have been trying to treat pain at the source with pain signal inhibitors like Journavx has, but it's just proved a very, very tricky problem to crack," chief operating officer Stuart Arbuckle told Axios.
- "It's literally taken 25 years for our scientists to get here."
- Clinical trials showed the drug worked as effectively as an opioid-based product and also was effective for chronic pain, an application for which Vertex plans to seek expanded use.
What we're watching: It's still an open question whether insurers will cover Journavx. The company has received positive feedback from commercial payers.
- Vertex is determining whether recent state and federal reimbursement policy changes will encourage uptake by hospitals amid a sea of cheaper generic opioids.
- "I do think there's been a real sea change over the last few years," Arbuckle said, adding he's been encouraged by signals from Washington that policymakers "really are trying to level the playing field."
