SciSparc subsidiary seeks FDA orphan designation for Tourette drug SCI-110

  • NeuroThera pursues FDA Orphan Drug Designation for SCI-110 in adult Tourette Syndrome.
  • 21% average tic reduction was measured using Yale’s Global Tic Severity Scale Total Tic Score.
  • Phase IIb trials began at centers in the United States, Germany and Israel.

SciSparc said its majority-owned subsidiary, NeuroThera Labs, is pursuing FDA (U.S. drug regulator) Orphan Drug Designation for SCI-110, a cannabinoid-based candidate for adults with Tourette Syndrome. NeuroThera engaged RK Strategies, a U.S. government and public affairs consulting and lobbying firm, to support the regulatory pathway and increase visibility among federal stakeholders. The designation applies to investigational therapies for rare diseases affecting fewer than 200,000 people in the United States and, if granted, could strengthen SCI-110’s market profile. The candidate combines dronabinol and palmitoylethanolamide in one oral dose and is intended to address tics and related comorbid symptoms while aiming to limit side effects. Its Phase IIb program is underway at academic centers in Connecticut, Germany and Israel, following Phase IIa results showing an average 21% tic reduction on the Yale Global Tic Severity Scale Total Tic Score. SciSparc said the clinical program and potential efficacy signals could support SCI-110’s development toward regulatory milestones and commercialization, while noting that these are forward-looking statements subject to risks and uncertainties.

The information on this website is generated using AI and we cannot guarantee its accuracy. Please use it as reference information only.