“We have made significant progress towards our goal of providing the first emergency antidote for acute cannabis-induced toxicity in children,” commented Richie Cunningham, Chief Executive Officer of Anebulo. “Anebulo previously evaluated selonabant as an oral treatment in a successful Phase 2 clinical trial, demonstrating potential for blocking and reversing the negative effects of acute cannabinoid intoxication (ACI) in healthy adults challenged with oral THC. The Company has since prioritized the advancement of a selonabant IV formulation as a potential treatment for pediatric patients with acute cannabis-induced toxicity, which it believes is a more serious condition that offers the potential for a faster timeline to approval relative to the adult oral product. Acute cannabis exposure in children can result in serious and potentially life-threatening consequences, including CNS depression, respiratory depression, coma, and in rare cases death. Cannabis toxic effects in children can be much more serious than in adults, and there is a much greater risk of hospitalization and admission to intensive care. In addition to the continuing collaborative support from NIDA, our interactions with the Food and Drug Administration to date have confirmed our belief that there is a significant and growing unmet need for a treatment for children exposed to cannabis toxicity. FDA has suggested a close collaboration with Anebulo to facilitate the development of selonabant for this important pediatric condition. If approved, we believe selonabant has the potential to offer a much-needed targeted therapy for rapidly reversing the serious and life-threatening consequences of acute cannabis-induced toxicity in children.”
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