11:17 AM EDT, 05/21/2024 (MT Newswires) -- Durect ( DRRX ) said Tuesday it obtained the breakthrough therapy designation from the US Food and Drug Administration for larsucosterol to treat people with severe alcohol-associated hepatitis.

The designation is backed by results from a phase 2b trial that assessed the safety and efficacy of larsucosterol, the company said.

Durect ( DRRX ) said it intends to confirm the efficacy and safety of the candidate drug in a registrational phase 3 trial.

The breakthrough therapy designation is designed to quicken the development and review of treatments targeting serious or life-threatening diseases.

The company's shares were up nearly 5% in recent trading.

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