SCI-110, our proprietary drug candidate, containing Dronabinol (FDA approved synthetic form of THC), with the endocannabinoid palmitoylethanolamide (PEA).
Designed to stimulate cannabinoid receptors across the Central Nervous System and inhibit the metabolic degradation of endocannabinoids in order to improve uptake of THC, the expected benefits of SCI-110 are an increase in efficiency of oral administration, and in turn a decrease in dosage requirements, side effects and adverse events.
This product is being developed under the accelerated regulatory path of 505 (b)(2) application focused on augmenting FDA-approved natural and synthetic cannabinoids to create alternate therapies that potentiate the effects of cannabinoids and target the receptors implicated in modulating the central nervous system.
This approach qualifies us for access to the FDA’s 505 (b)(2) regulatory strategy, created to facilitate the submission of novel drug candidates that meet specific criteria to the FDA for review. The 505 (b)(2) application provides us with several advantages as compared to a typical New Drug Application, including potential; lower risk and development costs, and a potentially expedited time to market.
Indications currently being investigated for treatment with SCI-110 include:
– Tourette Syndrome- (TS)
– Obstructive Sleep Apnea (OSA)
– Alzheimer’s Disease and Agitation