HQ Team
January 31, 2025: Vertex Pharmaceuticals Inc.’s non-opioid analgesic to treat moderate to severe acute pain in adults got approval from the US drug regulator.
The Food and Drug Administration gave the nod for Vertex’s Journavx oral tablets, which reduce pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system before pain signals reach the brain.
The suzetrigine, branded as Journavx, a 50-milligram oral tablet is the first drug to be approved in this new class of pain management medicines, according to an FDA statement. The FDA approval for suzetrigine is the first new mechanism for acute pain in more than 20 years.
Relief from pain is an important therapeutic goal. Acute pain is short-term pain that is typically in response to some form of tissue injury, such as trauma or surgery.
Acute pain is often treated with analgesics that may or may not contain opioids. The FDA has long supported the development of non-opioid pain treatment.
‘Public health milestone’
As part of the FDA Overdose Prevention Framework, the agency has issued draft guidance aimed at encouraging the development of non-opioid analgesics for acute pain and awarded cooperative grants to support the development and dissemination of clinical practice guidelines for the management of acute pain conditions.
“Today’s approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, JD, MD, acting director of the FDA’s Center for Drug Evaluation and Research.
“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,” she said.
The efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy.
In addition to receiving the randomised treatment, all participants in the trials with inadequate pain control were permitted to use ibuprofen as needed for “rescue” pain medication.
Itching, rash
Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo.
The safety profile of Journavx is primarily based on data from the trials of 874 participants with moderate to severe acute pain following abdominoplasty and bunionectomy.
It was supported with safety data from one single-arm, open-label study in 256 participants with moderate to severe acute pain in a range of acute pain conditions.
The most common adverse reactions in study participants who received Journavx were itching, muscle spasms, increased blood levels of creatine phosphokinase, and rash.
The FDA approval “is a historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year,” said Reshma Kewalramani, MD, Chief Executive Officer and President of Vertex.
New treatment space
“With the approval of Journavx, a non-opioid pain signal inhibitor and the first new class of pain medicine approved in more than 20 years, we have the opportunity to change the paradigm of acute pain management and establish a new standard of care,” she said.
The application received Breakthrough Therapy, Fast Track and Priority Review designations by the FDA.
The FDA greenlight comes a week after Purdue Pharma and the Sackler family agreed to pay $7.4 billion to settle lawsuits stemming from the company’s opioid-based painkiller OxyContin.
The FDA’s nod for the Vertex oral drug may create a new treatment space devoid of opioids. Companies such as Hyloris Pharmaceuticals SA, Tris Pharma, Latigo Biotherapeutics and SiteOne Therapeutics are trying to grab a hold in this space.
More than 80 million Americans are prescribed medicine to treat their moderate-to-severe acute pain every year. Of these, about 40 million are prescribed an opioid.
Nearly 10% of acute pain patients treated initially with an opioid will go on to have prolonged opioid use, and about 85,000 patients will develop opioid use disorder annually.
Poorly controlled acute pain can lead to reduced quality of life, development of chronic pain, and increased burden on the health care system and society.
