When you are staking your whole business on a make-or-break Phase III trial, failure can be devastating.
Just ask Neurana Pharmaceuticals.
The little San Diego biotech had enrolled 1,004 patients who suffer from pain due to acute back muscle spasms in a Phase III study of its lead drug, tolperisone, as the final leg of an effort to introduce to the US a skeletal muscle relaxant that’s been used in Europe since the 1960s.
But Neurana revealed late Tuesday that the study, dubbed RESUME-1, failed to meet primary and key secondary endpoints.
Across all three dose groups (50mg, 100mg, 200mg), patients given tolperisone three times per day for 14 days weren’t any less likely than those on placebo to report pain “right now” at Day 14, as measured by the Numerical Rating Scale — or, in the company’s words, “did not demonstrate significance.”
That was the first domino to fall….
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