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Pictured: JOURNAVX bottle and tablet (Photo: Business Wire)
The U.S. Food and Drug Administration (FDA) on Jan. 30 approved Vertex Pharmaceuticals’ JOURNAVX™ (suzetrigine) for treatment of acute pain “without evidence of addictive potential,” Vertex announced.
The first new class of pain medicine approved by the FDA in more than 20 years, JOURNAVX is a non-opioid, oral, pain signal inhibitor that targets NaV1.8 voltage-gated sodium channel, part of the nervous system that transmits pain to the brain.
“Because JOURNAVX blocks pain signals only found in the periphery, not in the brain, JOURNAVX provides effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids,” Vertex explained.
The state of pain in America
Vertex released a study, State of Pain in America.
To understand the impact of Vertex’s new approval, it is important to understand the state of pain management in America today, especially in the wake of the opioid epidemic.
Generally, there are two types of pain: acute and chronic. Acute pain is defined as any pain lasting less than three months, for example, because of an injury or surgery. Chronic pain, on the other hand, is prolonged and ongoing, resulting from issues like prolonged injury, arthritis, fibromyalgia, or even depression.
Not surprisingly, these two types of pain require different management approaches and pose unique challenges.
JOURNAVX is designated for the treatment of moderate-to-severe acute pain, making it an attractive alternative to opioids. And the need for non-opioid alternatives to treat acute pain is imperative. As Vertex explained in its recent “The State of Pain in America” survey, which collected responses from 1,001 U.S. adults and 547 health care providers, 89% of patients with acute pain said that it disrupted their daily life.
Additionally:
- 70% said their pain limited them from walking or exercising,
- 69% said their pain limited their sleep,
- 65% said their pain limited their leisure activities, and
- 65% said their pain made them feel irritable and emotionally drained.
And Vertex found a distinct need for medication alternatives:
- 77% said that they were interested in trying new pain medication in the future,
- 52% said they were seeking pain medication with fewer side effects, and
- About 31% said that they stopped taking their pain medication early, 58% of whom reported continued pain during that time.
Given the development pipeline for pain management medications, the exploration of JOURNAVX, as well as its approval, is impressive.
A new pain management alternative
Vertex took a page from the genetic record.
“Two decades ago, when two genetic mutations were discovered in Asia that gave scientists a better idea of how pain sensations traveled through the body and identified which part of the nervous system to target,” reported Fierce Biotech. “The discoveries of the genetic mutations in China and Pakistan had uncovered the voltage-gated sodium channel Nav1.7 as the key transmitter of pain. If pain-signaling ions are blocked from passing through the Nav1.7 channel, they can never reach the brain.”
Vertex pursued inhibiting these channels, and after years of development, they succeeded by targeting the closely related Nav1.8 channel. The company is now hoping that this innovation will pave the way for improved pain management that could expand into the chronic pain space.
And the fact that Vertex has its eye on continued development is notable. If drug development for acute pain is lacking, development for chronic pain is at a near standstill.
Success despite an atrophied development pipeline
As the Biotechnology Innovation Organization (BIO) found in a 2023 report, “The State of Innovation in Pain and Addiction,” 77% of the programs to develop pain drugs that were around in 2017 are no longer around, which is a net decline of 44%.
As Bio.News reported back in 2022, “The FDA withdrew the first guidance on non-opioid analgesics in 2017 and it has been five years where there’s been no guidance to the industry on development of these types of medicines.” BIO commented, “Establishing an unnecessarily high threshold for supporting a general acute pain indication could discourage the development of novel analgesic drugs for such uses.”
It’s important to clarify guidelines and support drug developers in this space. Not only are there fewer developers tackling pain, but the ones who are working on it face higher rates of failure.
“What we found is that as companies go into their first Phase 1 trial for pain medication, they have less than a one in 100 chance in making it to FDA approval—it’s 0.7% to be exact,” the paper’s author, David Thomas, said during a 2023 panel.
“The overall industry has a 90% success rate when they file with the FDA,” said Thomas. “For pain medications, the success rate is 57%.”
“One of the complaints we had from companies is that they wanted more clarity and confidence that what they were proving in their phase three studies would actually be what would qualify for an approval,” said Thomas during a one-on-one interview with Bio.News. “They also want more clarity on how they can actually get the clinical trials designed in a way that will make them more successful.”
As JOURNAVX moves into the market, drug developers will undoubtedly be watching what happens next.
