NOV 22, 2022

Non-Opioid Drug Moving to Phase 3 of Clinical Trials

WRITTEN BY: Amielle Moreno

For a long time, researchers have strived to discover new treatments for pathological pain. One focus has been to find a method of blocking sodium channels on nociceptor neurons. Now Vertex pharmaceuticals is announcing its non-opioid pain reliever, VX-548, will advance to Phase 3 clinical trials during the 2022 fourth quarter. The hope is this drug will offer a new and non-addictive alternative to opioid-based pain treatments.

Pain is supposed to warn us of a threat, but when it becomes chronic, it can have debilitating effects. Pathological pain is generally chronic and entails normally harmless sensations eliciting pain. It includes pain involving nerve injury (neuropathic) and tissue injury related inflammation. While opioids address acute pain well, they fall short when used as a pathological pain treatment.

NaV1.8 is a sodium voltage-gated channel that plays a role in peripheral nervous system pain signaling. It is selectively expressed on neurons whose cell bodies reside within the dorsal root ganglion near the spinal cord. This ion channel is highly expressed on neurons carrying pain information called nociceptors. The channel is linked to neuropathic but more prominently inflammatory pain. There’s evidence suggesting NaV1.8 has an effect on neighboring uninjured neurons, leading to their hyperexcitability.

Vertex’s VX-548 contains small, NaV1.8 channel targeting molecules to decrease or block activity. The oral medication’s Phase 3 clinical trial will include participants recovering from bunionectomy or abdominoplasty surgery. They will be randomly assigned in the double-blind and placebo-controlled study. Pain will be measured after 48 hours of treatment using the Numeric Pain Rating Scale. Proof-of-concept research indicated this treatment could aid in acute, neuropathic, and musculoskeletal pain.

It's been decades since the last non-opioid pain treatment was approved for consumer use. Vertex is hoping to “bring forward a medicine that delivers effective pain control without addictive potential to patients who are waiting” said Carmen Bozic, M.D., Executive Vice President of Vertex in their press release.

Sources: Vertex, Molecular Pain