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A-Synaptic believes that its US patented GT4 transdermal drug delivery system will provide a safer treatment alternative for many of the almost 500,000 American epileptic children. While oral delivered CBD is effective in reducing the number and severity of seizures suffered, the epileptic child needs to swallow large doses of CBD oil twice a day and must be monitored for possible serious liver toxicity
The First Transdermal Technology to Show Systematic Bioavailability of THC and CBD
The chart above shows the results of A-Synaptic’s human bioavailability study conducted in Canada as authorized by Health Canada. This is the first published study demonstrating the ability of a transdermal delivery system to transport clinical amounts of both CBD and THC through the skin into systemic circulation. This delivery method will bypass the liver toxicity issues caused by oral delivery.
GW Pharma’s orally delivered CBD product Epidiolex was approved by the FDA in 2018 to treat certain childhood epilepsy diseases. It has proved to be highly effective treatment but with liver safety concerns.
Despite the known liver toxicity issues related to oral delivery of large doses of CBD, Epidiolex has proved to be a commercial success. Revenue last year was over $800 million in only its fourth year of commercial sales. This rapid increase in sales did not go unnoticed. After Epidiolex sales reached $500 million in just its second year, GW Pharma agreed to a $7.2 billion ($220/share) acquisition by Jazz Pharmaceuticals. This was a 25-fold increase from GW’s NASDAQ IPO price of $8.90 per share.
The very positive human trial results highlighted in the chart above supports A-Synaptic’s beliefs that GT4 will provide a more efficient and far safer method of delivering this highly effective treatment. This combined with the FDA’s shortened and less costly 505(b)(2) approval process should provide A-Synaptic’s shareholders with the opportunity to benefit from the launch of a competitor to this $800 million annual sales prescription CBD product.