Vertex wins 'breakthrough' nod for non-opioid pain drug; After US withdrawal, EMA restricts Clovis' Rubraca
Vertex won a breakthrough therapy designation for its non-opioid pain drug, the company announced Friday.
Regulators bestowed the designation upon VX-548, an experimental pill targeting nerve receptors, for the treatment of moderate-to-severe acute pain. The move comes about four months after Vertex said the program achieved its primary goals in two Phase II studies.
With the BTD, Vertex added that the FDA has also signed off on its plan for a pivotal trial program.
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