FDA approves ‘first’ of new class of non-addictive drugs for severe pain

The US Food and Drug Administration (FDA) has approved a non-opioid drug for severe post-surgical pain, which could “redefine pain management”.

Journavx is an oral and selective “pain signal inhibitor” developed by US biotech Vertex Pharmaceuticals.

The company says the drug provides effective pain relief without the addictive potential of opioids.

Reshma Kewalramani, CEO of Vertex Pharmaceuticals, said: “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.”

Opioids for pain relief

Moderate-to-severe acute pain is usually short term and results from some form of tissue damage, including trauma after an accident or surgery.

Journavx works by blocking the pain signals transmitted from the peripheral nervous system before they reach the brain.

The FDA says the drug is the first of a class of non-opioid analgesic treatments it is supporting via its Overdose Prevention Framework.

Safety

Analgesics are medications used to manage the treatment of pain; this includes opioids which are widely used in the US to treat severe pain. Physicians are advised to prescribe opioids sparingly when benefits outweigh the risks due to their potential for addiction, tolerance, and side effects.

Journavx was trialled on 874 participants experiencing moderate-to-severe acute pain following abdominoplasty (tummy tucks) and bunionectomy.

After a series of placebo, double-blind, and active-controlled trials, the researchers found the drug demonstrated a “statistically significant superior reduction” in pain compared with placebo.

However, side effects included itching and muscle spasms, with Vertex saying the drug may not be suitable for people who are pregnant or have liver problems.

With Journavx now on the US market for acute pain, Vertex is currently evaluating its potential to treat peripheral neuropathic pain. The company is hoping to conduct trials on patients with lumbosacral radiculopathy, a condition often referred to as sciatica.