Search Results for: Epidiolex

FDA Statement Statement From FDA Commissioner Scott Gottlieb, On Signing Of The Agriculture Improvement Act And The Agency’s Regulation Of Products Containing Cannabis And Cannabis-derived Compounds

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DISTRICT OF COLUMBIA: Today (December 20, 2018), the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry Read the full article…

FSD Pharma Appoints Top GW Pharmaceuticals Executive As Chief Executive Officer

FSD Pharma

Management addition comes as FSD accelerates specialty cannabinoid pharmaceutical global expansion strategy CANADA:  FSD Pharma announced today the appointment of Rupert Haynes as Chief Executive Officer. Mr. Haynes is a highly accomplished healthcare executive with nearly three decades of global pharmaceutical experience having most recently held the position of Head of Global Marketing at GW Pharmaceuticals Read the full article…

FDA Approves Marketing Of Plant-Derived Marijuana Medicine

GW Pharmaceuticals Epidiolex

DISTRICT OF COLUMBIA:  Regulators at the US Food and Drug Administration on Monday granted market approval to Epidiolex, a prescription medicine containing a standardized formulation of plant-derived cannabidiol (CBD) for the explicit treatment of two rare forms of severe epilepsy: Lennox-Gastaut syndrome and Dravet syndrome. The proprietary extract formulation – developed by the British biotechnology firm GW Pharmaceuticals – had Read the full article…

FDA Approves First Cannabis-Based Epilepsy Drug

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MARYLAND: The U.S. Food and Drug Administration has approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from Read the full article…

Study: CBD Extracts Significantly Reduced Seizure Frequency In Children With Refractory Epilepsy

Israeli researchers assessed the sustained daily use of extracted CBD oils in a cohort of young patients with treatment resistant epilepsy.

ISRAEL: The adjunctive use of CBD extracts is safe and effective in adolescent patients with refractory epilepsy, according to clinical data published online ahead of print in the journal Brain & Development. Israeli researchers assessed the sustained daily use of extracted CBD oils in a cohort of young patients with treatment resistant epilepsy. Thirty-five percent of participants experienced a Read the full article…

Review: Adjunctive Use Of Cannabinoids Efficacious In Patients With Treatment-Resistant Epilepsy

there was qualitative evidence that cannabinoids reduced seizure frequency in some patients, improved other aspects of the patients' quality of life and were generally well tolerated with mild-to-moderate AEs (adverse events)

AUSTRALIA: The adjunctive use of cannabinoids, particularly CBD (cannabidiol), typically reduces seizure frequency and improves the quality of life in patients with intractable forms of epilepsy, according to a review of clinical data published in the Journal ofNeurology, Neurosurgery & Psychiatry. Australian researchers reviewed data from six randomized, placebo-controlled studies, involving 555 patients, and from another 30 observational trials, Read the full article…

Study: Artisanal CBD Preparations Associated With Reduced Seizure Activity In Epileptic Children

CBD is big business

TENNESSEE: Cannabidiol administration is associated with a significant reduction in seizure frequency in patients with drug-resistant pediatric epilepsy, according to data published in the journal Epilepsy & Behavior. Vanderbilt University researchers retrospectively assessed the impact of the adjunctive use of grey-market CBD products in a cohort of 108 children with refractory epilepsy. Authors reported: “The addition of CBD resulted Read the full article…

FDA Grants ‘Priority Review’ Of Plant-Derived CBD Extract

If Epidiolex achieves FDA-approval, analysts suggest the product could retail for between $30,000 to $60,000 annually.

DISTRICT OF COLUMBIA: Representatives of the US Food and Drug Administration will undertake a ‘priority review‘ of data specific to the safety and efficacy of Epidiolex, a standardized, plant-derived CBD extract formulated by a British pharmaceutical company. The review is scheduled to be completed by June 27, 2018. Phase III clinical trial data shows that Epidiolex Read the full article…

This Presidential Candidate Plans To Fully Legalize Marijuana

This presidential candidate wants to legalize marijuana

If you said a decade ago that marijuana would be one of the key issues that would decide our next president, I’d probably have chuckled. However, the reality is that marijuana is very much entrenched as a hot-button issue in the 2016 elections. Believe it: marijuana is a hot-button issue With the rare exception, marijuana’s Read the full article…

Study Confirms Safety Of Cannabis Drug CBD

An early American study has assessed the safety of a drug made from a compound derived from cannabis.

NEW YORK:  Using a drug based on a chemical found in the cannabis plant to treat epilepsy has been controversial to say the least. An early study from the US may lend more weight to its scientific standing, however. The study suggests that the drug is safe, well-tolerated and effective. An early American study has Read the full article…