Wikipedia

Late-stage trial results for a pain medication developed by Vertex Pharmaceuticals reinforced experts’ sense that the drug was both safe and offered modest pain relief. But the findings also prompted fresh debate on Tuesday about how widely used the therapy would be should it win regulatory approval.

The company reported that its small molecule drug, VX-548, outperformed placebo in a pair of pain relief trials that recruited patients who had gotten an abdominoplasty (tummy tuck) or bunion surgery. The study also found that the drug was generally safe, with fewer patients on the medication reporting adverse events than those who had taken a placebo. But there was a catch: VX-548 didn’t outperform a combination of acetaminophen and the opioid hydrocodone, a key secondary endpoint. And in the bunionectomy study, the opioid comparator beat VX-548 on pain relief.

advertisement

“While this study was not explicitly designed to test VX-548 vs. the opioid comparator, this may complicate the prescribing decision in the acute setting, where patients often take a short course of treatment and efficacy is a primary consideration,” Stifel market analyst Paul Matteis wrote in a note to investors, adding that results from three Phase 3 studies were positive overall.

Get unlimited access to award-winning journalism and exclusive events.