FDA Approves Journavx, New Nonopioid Med, for Acute Pain

The FDA recently approved Vertex Pharmaceuticals Incorporated’s Journavx (suzetrigine), a first-in-class non-opioid medication for treating moderate to severe acute pain in adults.

Journavx, approved for a twice-daily use, offers an alternative to opioids for patients experiencing acute pain.

Targeting the NaV1.8 pain-signaling receptor, the oral drug prevents pain signals from reaching the brain, according to a news release by Vertex.

Acute pain is a serious condition often caused by surgery, accidents or injuries.

Over 80 million Americans receive prescriptions for moderate-to-severe acute pain, annually. Roughly 40 million of those prescriptions are for opioids, the release said.

Unfortunately, nearly 10% of patients initially treated with opioids develop prolonged use, and about 85,000 people annually develop opioid use disorder.

In addition, poorly managed acute pain can lead to reduced quality of life and development of chronic pain.

As a non-opioid drug, Journavx can assist patients effectively and without showing signs of being addictive.

Reshma Kewalramani, M.D., president and CEO of Vertex expressed that the approval is a historic milestone for the millions of Americans affected by acute pain.

“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,” Kewalramani said.

This approval was based on two randomized, double-blind, placebo- and active-controlled clinical trials that demonstrated a significant reduction in pain compared to placebo.

One trial involved patients recovering from abdominoplasty, while the other focused on patients undergoing bunionectomy.

The safety profile of the drug was based on data involving 874 participants with moderate to severe acute pain following these surgeries, along with additional supportive data from an open-label study with 256 participants.

The most common side effects of Journavx included itching, muscle spasms, elevated creatine phosphokinase levels and skin rash.

In addition, Journavx is not recommended for use with strong CYP3A inhibitors, and patients should avoid consuming grapefruit products while taking the medication.

Vertex Pharmaceuticals has set the wholesale cost of the medication at $15.50 per 50 mg pill.

Beyond its current approval, Vertex is also exploring the use of Journavx in other conditions, such as peripheral neuropathic pain.

The company is also conducting a phase 3 trial for patients with painful diabetic peripheral neuropathy and plans to further study the drug’s potential in treating painful lumbosacral radiculopathy after discussions with regulatory agencies.