DURECT Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to larsucosterol for the treatment of patients with severe alcohol-associated hepatitis (AH). The BTD is supported by clinical evidence from the Phase 2b AHFIRM trial, a double-blind, placebo-controlled, international, multi-center study, which evaluated the safety and efficacy of larsucosterol as a treatment for patients with severe AH. BTD provides therapeutics with all the benefits from a Fast Track designation, such as early and frequent communication with the FDA, eligibility for rolling review and other actions to expedite review, in addition to intensive guidance and organizational commitment involving senior FDA managers.

The Company enrolled patients at clinical trial sites across the U.S., EU, U.K., and Australia. Reflecting the life-threatening nature of AH and the lack of therapeutic options, the U.S. Foodand Drug Administration (FDA) have granted larsucosterol Fast Track designation and Breakthrough Therapy designation for the treatment of AH. There are no FDA approved therapies for AH, and a prospective analysis of 77 studies published between 1971 and 2016, which included data from 8,184 patients, showed the overall mortality from AH was 26% at 28 days, 29% at 90 days and 44% at 180 days.

Larsucosterol is in clinical development for the potential treatment of AH, for which the FDA has granted a Fast Track and a Breakthrough Therapy designation; metabolic dysfunction-associated steatohepatitis (MASH) is also being explored. In addition, POSIMIR (bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER platform technology, is FDA-approved and is exclusively licensed to Innocoll Pharmaceuticals for sale and distribution in the United States. The potential risks and uncertainties that could cause actual results to differ from those projected include, among other things, the risk that future clinical trials of larsucosterol are delayed or do not confirm the results from subset analyses of the AHFIRM trial, including geographic or other segmentation, or of earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of larsucosterOL in a statistically significant manner; the risk that the FDA or other government agencies may require additional clinical trials for larsucosterol before approving larsucosterol for The treatment of AH, the risk that the FDA or Other government agencies may require additional clinical trial for larsucosterol forthe treatment of AH, the risk of larsucosterol for, the risk that the FDA and other government agencies may require additionalclinical trials for larsucosterOL before approving larsucosterOL for the treatment of AH, the risk the FDA or other government agencies will require additional clinical trials for lARSucosterol before approving lARSucosterol for the treatment the treatment of AH, the risks that Innocoll may not commercialize POSIMIR successfully; and risks related to the suffering of cash resources, anticipated capital requirements, need or desire for additional financing, ability to continue to pursue additional clinical trials.