FX.co ★ Vertex's Experimental Pain Drug Meets Phase 3 Primary Goal

Vertex Pharmaceuticals has recently announced that their experimental pain medication, potentially an alternative to opioids, successfully achieved its primary objective in a Phase 3 trial.

Over 1,100 participants who underwent either abdominoplasty or bunionectomy surgeries were enrolled in the study. Initially, these participants were administered 100 milligrams of the drug, followed by further doses of 50 milligrams every 12 hours for up to 36 hours post-first dosage.

This experimental pain medication, VX-548, was shown to be more effective than a placebo in alleviating post-surgical pain in both the surgeries, according to the company’s statement. In another smaller Phase 3 trial, this medication was proven to be safe and efficient in pain relief.

Dr. David Altshuler, the research chief at Vertex, stated that the results of these trials suggest that VX-548 may offer a unique and powerful solution for patients suffering from acute pain. He further explained that the drug works by inhibiting pain in the peripheral nervous system rather than targeting the brain, which contributes to its increased effectiveness in reducing pain intensity even 48 hours after administration.

However, the drug did not achieve its secondary objective of outperforming a combination of opioid drugs; hydrocodone and acetaminophen, commonly known as Vicodin, in pain relief.

Despite this, Vertex pointed out that the experimental drug showed fewer side effects such as nausea, headaches, constipation, and dizziness compared to other pain medications.

The company plans to seek approval from the U.S. Food and Drug Administration by mid-2024. If approved, analysts predict that the drug would generate more than $5 million in annual sales.