A novel pain drug from Vertex Pharmaceuticals met its goals in two mid-stage trials, the company said Thursday, paving the way for pivotal trials that could lead to approval.
The highest dose of the drug, a pill called VX-548, beat placebo at reducing patients’ pain within 48 hours of surgery, Vertex said. The company tested its medicine in two studies, enrolling about 550 patients who had just undergone either abdominoplasty or bunionectomy, giving them either placebo, the opioid treatment hydrocodone, or one of three dosage strengths of VX-548.
Vertex now plans to advance VX-548 into pivotal studies in the second half of this year, pending permission from the Food and Drug Administration.
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