STAT+: Vertex’s closely watched pain relief drug succeeds in late-stage trials — with a catch
Results announced Tuesday by Vertex bring the biopharma giant a step closer to launching what observers believe could be a potential blockbuster.
A pain relief drug developed by Vertex Pharmaceuticals succeeded in late-stage clinical trials, the company announced Tuesday, bringing the biopharma giant a step closer to launching what observers believe could be a potential blockbuster and upending decades of pharma failure in a complicated field.
In a pair of randomized, placebo-controlled Phase 3 trials for patients with pain after a tummy tuck or bunion surgery, the drug showed statistically significant pain reduction compared to placebo, meeting the primary endpoints for these studies and the expectations of market analysts. But the experimental therapy didn’t relieve pain better than a combination of acetaminophen and the opioid hydrocodone, a key secondary endpoint observers had been waiting on. And in the bunionectomy trial, the opioid comparator outperformed VX-548 at soothing pain.
The drug, a small molecule known as VX-548, blocks pain-sensing neurons from signaling the pain without the addictive potential of opioids. It was generally safe, with fewer patients on VX-548 reporting adverse events than those taking the placebo.
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