A non-opioid pain reliever has demonstrated efficacy in two extensive clinical trials, sparking optimism that it could present an alternative to potent yet addictive medications like OxyContin and Vicodin. Developed by biotech firm Vertex Pharmaceuticals, the drug showed significant pain reduction post-surgery compared to a placebo, with participants experiencing relief within a few hours of receiving the treatment. Moreover, the drug exhibited minimal side effects, supporting Vertex’s assertion that its medication, VX-548, could have broad applicability.
Vertex intends to seek approval from the FDA for VX-548 in moderate-to-severe acute pain by mid-year, with company spokesperson David Altshuler emphasizing the urgency of the filing. While VX-548 fell short of surpassing a combination of hydrocodone bitartrate and Tylenol in one of its key secondary objectives, its overall success offers a glimmer of hope in the ongoing struggle to develop non-addictive pain management solutions amid the opioid crisis.
The drug’s foundation lies in research highlighting the role of sodium channels, specifically Nav1.8, in transmitting pain signals. Encouraged by promising mid-stage trial results, Vertex proceeded with two Phase 3 studies involving over 1,100 participants each, assessing VX-548’s effectiveness in managing acute pain following bunion surgery or abdominoplasty. Results demonstrated significant pain reduction compared to placebo, although VX-548 did not statistically outperform the opioid combination in either trial.
Vertex highlighted VX-548’s safety profile, in comparison to opioids, emphasizing its potential to address the perennial trade-off between pain relief and addiction risk. Adverse events associated with VX-548 were fewer and milder than those reported in the placebo and combination treatment groups. A smaller Phase 3 trial involving approximately 250 individuals further reinforced VX-548’s efficacy across various types of acute pain.
The positive outcomes mark a pivotal moment for Vertex, which aims to diversify its portfolio beyond cystic fibrosis treatments. CEO Reshma Kewalramani envisions VX-548 as a lucrative addition to the company’s offerings, with analysts projecting substantial peak annual sales if approved. Experts view VX-548 as a pioneering agent in a potentially transformative class of pain medications, although challenges remain, particularly in addressing chronic pain associated with neurological changes.
In addition to ongoing trials in chronic pain, Vertex is exploring successor molecules to VX-548.
