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Significance: Treatment effect (efficacy and AEs) of CBD may occur within 1 week of starting treatment. Although AEs lasted longer for CBD than placebo, most resolved within the 14-week period.

Methods: Patients received plant-derived pharmaceutical formulation of highly purified CBD (Epidiolex, 100 mg/ml oral solution) at 10 mg/kg/day (CBD10; GWPCARE3) or 20 mg/kg/day (CBD20; both trials) or placebo for 14 weeks. Treatment started at 2.5 mg/kg/day for all groups and reached 10 mg/kg/day on Day 7 and 20 mg/kg/day (CBD20 and matching placebo only) on Day 11. Percentage change from baseline in drop seizure frequency was calculated by cumulative day (i.e., including all previous days). Time to onset and resolution of AEs were evaluated.

Keywords: antiepileptic drug; antiseizure medication; childhood onset epilepsy; drop seizures; treatment-resistant epilepsy.

Results: Overall, 235 patients received CBD (CBD10 [GWPCARE3 only], n = 67; CBD20 [pooled GWPCARE3&4], n = 168) and 161 received placebo. Mean (range) age was 15.3 years (2.6-48.0). Patients had previously discontinued a median (range) of six (0-28) antiepileptic drugs (AEDs) and were currently taking a median of three (0-5) AEDs. Differences in drop seizure reduction between placebo and CBD emerged during the titration period and became nominally significant by Day 6 (p = .008) for pooled CBD treatment groups. Separation between placebo and CBD in ≥50% responder rate emerged by Day 6. Onset of the first reported AE occurred during the titration period in 45% of patients (CBD10, 46%; CBD20, 52%; placebo, 38%). In patients with AEs, resolution occurred within 4 weeks of onset in 53% of placebo and 39% of CBD patients and by end of study in 63% of placebo and 61% of CBD patients.

Objective: To estimate time to onset of cannabidiol (CBD) treatment effect (seizure reduction and adverse events [AEs]), we conducted post hoc analyses of data from two randomized, placebo-controlled, Phase 3 trials, GWPCARE3 (NCT02224560) and GWPCARE4 (NCT02224690), of patients with Lennox-Gastaut syndrome.

© 2021 The Authors. Epilepsia published by Wiley Periodicals LLC on behalf of International League Against Epilepsy.

Freedom Leaf, Inc. does not handle, grow, sell, or dispense marijuana or related products.

All of our European activities are in full compliance with relevant EU laws.

Carter Terry & Company acted as the sole placement agent in this transaction.  Carter Terry is a full-service broker-dealer and investment banking firm located in Atlanta, Georgia.

Las Vegas, Nevada–(Newsfile Corp. – October 3, 2018) – Freedom Leaf Inc. (OTCQB: FRLF) owner of full spectrum CBD brands IrieCBD and Hempology ("Freedom Leaf or the "Company"), announced today that it has received a significant investment from cannabis private equity firm Merida Capital Partners ("Merida") to further expand its existing US sales channels and accelerate its European hemp cultivation operations.  Freedom Leaf and Merida have also agreed in principal to a strategic partnership by which Merida will provide certain operational resources and support for both Freedom Leaf's US hemp-based cannabidiol (CBD) sales efforts and their global cultivation operations. In connection with Merida's investment, Merida Senior Partner David Goldburg will be joining the Freedom Leaf Board of Directors.   

"Merida's investment is a validation of Freedom Leaf's aggressive efforts to build a high-quality family of cannabidiol-based products, but it is also an acknowledgement of the potential for the Valencia, Spain cultivation facility to become a significant supplier of both hemp and cannabis to European markets in the immediate future," said Mitch Baruchowitz, Managing Partner of Merida Capital Partners.

Freedom Leaf Inc. (OTCQB: FRLF), a group of diversified, international, vertically-integrated hemp businesses concentrating on health, wellness, and education as well as cannabis media companies. Freedom Leaf, Inc. has been a leading go-to resource in the cannabis, medical marijuana and industrial hemp industries since 2014, founded by professionals with decades of combined experience in marijuana legalization advocacy. FRLF is building a diverse portfolio of valuable businesses through strategic mergers, acquisitions, and acceleration projects across the industry.

Added David Goldburg, "I am excited to work closely with the Freedom Leaf team to rapidly expand their US CBD footprint while developing their European operations, including working with recent Merida investee, Italian CBD production company Materia Medica Processing."