Updated: Vertex unveils PhIII plans for non-opioid drug following mid-stage success in peripheral neuropathic pain

Ver­tex’s non-opi­oid treat­ment can­di­date for acute pain has met the pri­ma­ry end­point of pain re­duc­tion in a Phase II tri­al in di­a­bet­ics with neu­ro­path­ic pain, spark­ing plans for a move in­to Phase III and send­ing the com­pa­ny’s shares soar­ing.

The Phase II tri­al in­ves­ti­gat­ed VX-548 across sev­er­al dose co­horts ver­sus Vi­a­tris’ Lyri­ca in peo­ple with di­a­bet­ic pe­riph­er­al neu­ropa­thy. The tri­al was not pow­ered to make a di­rect com­par­i­son be­tween the treat­ment and con­trol arms but in­stead used Lyri­ca da­ta as con­text. Lyri­ca is a non-nar­cot­ic an­ti­con­vul­sant that car­ries a warn­ing for breath­ing dif­fi­cul­ties and in­creased risk of sui­ci­dal thoughts and be­hav­ior; VX-548 is a small-mol­e­cule in­hibitor of se­lect volt­age-gat­ed pe­riph­er­al sodi­um chan­nels.

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