Ron Strider
Well-Known Member
This time next year, an investigational drug hailed as a breakthrough in the science of cannabidiol could be prescribed to children suffering from treatment-resistant epilepsy.
The prospect of its success, however, has caused some unease in the American hemp industry.
London-based GW Pharmaceuticals plc is steering its proprietary Epidiolex oral solution through the U.S. Food and Drug Administration's approval pipeline.
Unlike other FDA-approved drugs that emulate the properties of THC, the psychoactive component of cannabis, Epidiolex (eh-pih-DYE-uh-lehx) utilizes another of the plant's compounds: non-psychoactive cannabidiol. GW's pharmaceutical formulation of purified CBD is targeted for treating rare, early onset seizure disorders including Dravet and Lennox-Gastaut syndromes, as well as Tuberous Sclerosis Complex and Infantile Spasms.
The company is expected to wrap up its New Drug Application to the FDA in the coming weeks; the federal agency could conduct its Good Manufacturing Practices (GMP) inspection by June.
If the FDA were to give its blessing to that application, Epidiolex could be readied for commercial sale on the prescription drug market by this time next year, GW officials told The Cannabist.
Cannabis advocates and purveyors of hemp-derived, CBD-rich extracts fear FDA approval of Epidiolex could lead to a pharmaceutical commandeering of promising cannabis compounds.
The company and some prominent members of the medical community, however, trumpet the attempt to harness CBD's potential and package it into a medicine that conveys the safety, consistency and clarity that FDA approval affords.
News Moderator: Ron Strider 420 MAGAZINE ®
Full Article: Race for CBD medication breakthrough: Is pharmaceutical firm’s boon the hemp industry’s doom? – The Denver Post
Author: Alicia Wallace
Contact: How to contact us — The Denver Post
Photo Credit: Kathy Young
Website: The Denver Post – Colorado breaking news, sports, business, weather, entertainment.
The prospect of its success, however, has caused some unease in the American hemp industry.
London-based GW Pharmaceuticals plc is steering its proprietary Epidiolex oral solution through the U.S. Food and Drug Administration's approval pipeline.
Unlike other FDA-approved drugs that emulate the properties of THC, the psychoactive component of cannabis, Epidiolex (eh-pih-DYE-uh-lehx) utilizes another of the plant's compounds: non-psychoactive cannabidiol. GW's pharmaceutical formulation of purified CBD is targeted for treating rare, early onset seizure disorders including Dravet and Lennox-Gastaut syndromes, as well as Tuberous Sclerosis Complex and Infantile Spasms.
The company is expected to wrap up its New Drug Application to the FDA in the coming weeks; the federal agency could conduct its Good Manufacturing Practices (GMP) inspection by June.
If the FDA were to give its blessing to that application, Epidiolex could be readied for commercial sale on the prescription drug market by this time next year, GW officials told The Cannabist.
Cannabis advocates and purveyors of hemp-derived, CBD-rich extracts fear FDA approval of Epidiolex could lead to a pharmaceutical commandeering of promising cannabis compounds.
The company and some prominent members of the medical community, however, trumpet the attempt to harness CBD's potential and package it into a medicine that conveys the safety, consistency and clarity that FDA approval affords.
News Moderator: Ron Strider 420 MAGAZINE ®
Full Article: Race for CBD medication breakthrough: Is pharmaceutical firm’s boon the hemp industry’s doom? – The Denver Post
Author: Alicia Wallace
Contact: How to contact us — The Denver Post
Photo Credit: Kathy Young
Website: The Denver Post – Colorado breaking news, sports, business, weather, entertainment.
