Vertex: non-opioid pain reliever Journavx shows success in post operative pain control

1. In two randomized clinical trials evaluating pain control following abdominoplasty and bunionectomy, Journavx demonstrated statistically significant reductions in acute surgical pain over 48 hours compared to placebo.

2. Journavx demonstrated safety in 3 clinical trials, with no serious side effects. Minor side effects included itching, muscle spasms, rash, and increased levels of creatine phosphokinase.

The Latest

Recently, two phase 2, randomized, double blind, placebo-controlled trials assessed the efficacy and safety of Journavx in controlling acute surgical pain. In the first trial evaluating post abdominoplasty pain as a model of soft tissue pain, patients taking Journavx had a 47% drop in pain levels, compared to 31% in patients taking placebo and 43% in patients taking hydrocodone/acetaminophen. In the second trial for pain control following bunion removal, a model of bone pain, Journavx achieved 51% reduction in pain level, compared to 53% for hydrocodone/acetaminophen and 38% for placebo. In both studies, Journavx achieved statistically significant pain reduction compared to placebo, but not compared to hydrocodone/acetaminophen.

Physician’s Perspective

Post operative pain is a common challenge for patients and doctors. Providing safe but adequate pain control improves patient outcomes but can be challenging for healthcare providers to facilitate given limitations of available pain medications. In addition to this, on the physiological level the pain process involves a complex interplay of multiple pathways which can further complicate management. Opioids are often used to treat severe acute pain, but because they reduce pain by acting on the brain, they carry risks such as sedation and addiction. Other available pain medications include acetaminophen or nonsteroidal anti-inflammatory drugs. A non-opioid candidate offers a novel, and potentially better alternative to the current standard of care with respect to several areas including not only pain control but also reduction in side effects and opioid dependence.

Molecular Targets

Journavx blocks Na_V1.8 voltage gated sodium channels in the peripheral nervous system, which includes all nerves in the body outside the brain and spinal cord. Blocking this channel prevents pain signals from being transmitted to the brain and interpreted as pain. As an oral analgesic, Journavx can provide systemic pain control, but without the risk associated with opioids. Journavx is the first approved medication in this class to treat acute pain.

Company History

Vertex Pharmaceuticals is an American biopharmaceutical company known for its previous work developing gene therapies and cystic fibrosis treatments. Vertex recently sponsored the two randomized control trials evaluating Journavx for acute pain relief, which has led to FDA approval of Journavx. This is a significant milestone for Vertex, as it is the first approval for a new pain medication in 25 years.

Further reading: https://www.nejm.org/doi/full/10.1056/NEJMoa2209870

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