U.S. health officials approve first marijuana-based prescription drug

Epidiolex a medicine made from the marijuana plant but without THC

Made by the British biopharma company GW Pharmaceuticals, Epidiolex uses purified cannabidiol, or CBD, which is one of more than 80 active compounds in the cannabis sativa plant, often known simply as marijuana. The U.S. Food and Drug Administration approved Epidiolex, a cannabidiol oral solution for the treatment of seizures related to epilepsy.

Side effects included sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor quality sleep and infections.

Critically, the drug will be available to patients nationwide, not just in states where cannabis is legal for medical purposes. "However, it remains to be seen whether physicians will be comfortable prescribing this new agent to those patients who may benefit from it, and whether it will be priced in a range that patients may afford".




Lennox-Gastaut syndrome and Dravet syndrome are both rare conditions that develop in childhood involving frequent seizures. More importantly, a DEA representative recently affirmed that outlook, telling Leafly reporter Ben Adlin that if Epidiolex is approved, the DEA will "absolutely" reschedule CBD. Some parents have used unapproved CBD oils to treat their children.

The FDA's green light on Epidiolex, coupled with the DEA's reclassification of CBD, could have big implications for the future of cannabis-based medicine. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. The FDA is willing to help companies that want to pursue such research programs, he said, but they need to prove their products work and are safe with data from clinical trials. FDA Commissioner Scott Gottlieb further added: "This is the approval of one specific CBD medication for a specific use". Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions. Shinnar said he will welcome approval of a medicine that had undergone stringent FDA review for safety and effectiveness. GW Pharmaceuticals grows the plants in the United Kingdom.

A total of 30 US states, the District of Columbia, Guam and Puerto Rico allow the use of medical marijuana in some form, according to the US National Conference of State Legislatures. This status has stifled rigorous research, because the federal government will not pay for it. Previous year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health. But GW said it expects that the DEA will reschedule CBD within 90 days. Another 20 states allow medical marijuana, but the US government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD. And the company plans to continue importing the medicine, bypassing onerous USA regulations on manufacturing restricted substances. "This is how sound medical science is advanced". The AP is exclusively responsible for all content.

Related news:

Hot News

isis-killer-beheading-video-story-top Germany's Hummels fit but Rudy a doubt for South Korea clash
Jun 26, 2018 - 03:20
Joachim Loew's team are fighting to avoid becoming the first German side to exit a World Cup at the first-round stage since 1938. Holders Germany were on the brink of crashing out of the World Cup following OlaToivolen's first half opener for Sweden.

isis-killer-beheading-video-story-top Supreme Court Ruling Opens Door to Online Sales Tax
Jun 26, 2018 - 03:16
The Supreme Court overrules the Quill case, which previously set the precedent for collecting sales tax from online sellers. Critics of the decision said it would unduly burden and harm small businesses, which the majority acknowledged was possible.

isis-killer-beheading-video-story-top In election victory speech, Erdogan says Turkey will advance in Syria
Jun 26, 2018 - 03:02
Erdogan swept the Sunday presidential polls while his ruling party and its nationalist allies secured a majority in parliament. Terrorism was another key issue, as Turkey faces attacks from Kurdish militants and the jihadists of the Islamic State group.

isis-killer-beheading-video-story-top Saudi Arabia vs Egypt tips
Jun 26, 2018 - 01:46
Salem Al-Dawsari's late goal secured Saudi Arabia a first World Cup win in 24 years with a 2-1 victory over Egypt in Volgograd. Egypt took the lead in the 22nd minute as Mohamed Salah scored a delightful goal, his second of the tournament.

isis-killer-beheading-video-story-top Amazon may have spilled the beans for Prime Day 2018
Jun 24, 2018 - 10:07
Aside from that, we're also expecting Amazon Marketplace sellers to get in on the act in a big way this year. For reference, Prime Day 2017 kicked off at 6 pm PST and ended 30 hours later at midnight.

isis-killer-beheading-video-story-top Finally, Supreme Court equalizes internet sales tax rules
Jun 24, 2018 - 02:09
Amazon , which accounts for more than 40% of online retail sales, already collects sales taxes on direct purchases from its site. The Supreme Court has ruled 5-4 (pdf) to greenlight state sales tax for online purchases, reversing a decade-old precedent.

isis-killer-beheading-video-story-top Kit Harington and Rose Leslie's wedding is coming
Jun 24, 2018 - 01:45
And the June 23 date was posted at the Huntly registration office in Aberdeenshire, in the north east of Scotland, last month. Leslie, born Rose Eleanor Arbuthnot-Leslie, first rose to fame in Season 1 of BBC's hit drama "Downton Abbey".

isis-killer-beheading-video-story-top Nick Jonas and Priyanka Chopra Take Their Romance To India
Jun 24, 2018 - 01:07
The singer shared an Instagram story of the Quantico actress dancing, before blushing and urging him to put his phone away. This user says Priyanka and Nick must concentrate on each other and ignore those who throw brick-brats against them.

Javier Hernandez Hits Half-Century As Mexico Battle Past South Korea
Jun 23, 2018 - 23:57
Only a Germany win will prevent South Korea being knocked out with a group game remaining. The 20-year-old Alvarez, one of Mexico's hottest prospects, replaces Hugo Ayala .

isis-killer-beheading-video-story-top Trump signs order ending family separation policy
Jun 23, 2018 - 23:47
Trump, whose focus as first lady is on child well-being, appears to have been among those pushing her husband to act. Trump's solution is to imprison parents and children together.

isis-killer-beheading-video-story-top Former Federal Prosecutors Urge Sessions to End Family Separations
Jun 22, 2018 - 04:02
Attorney General Jeff Sessions speaks at the National Sheriffs' Association convention in New Orleans, Monday, June 18, 2018 .

Why Melania Trump Is Facing Criticism for Her Latest Fashion Statement
Jun 22, 2018 - 03:54
Many have praised Trump for seeming to diverge from Donald Trump's attitude on separating children from their families. At an immigration detention center, Trump made brief comments about her goals on the trip. "It's a jacket .

isis-killer-beheading-video-story-top Spain survive "heart attack" game against feisty Iran
Jun 22, 2018 - 03:44
Spain earned its first win at the 2018 World Cup on Wednesday, narrowly beating Iran 1-0 on a fortunate goal from Diego Costa. The 24-year-old was supporting her partner and father of her two children as Portugal beat Morocco 1-0 to go top of Group B.

isis-killer-beheading-video-story-top Putin trolls Federation Internationale de Football Association by inviting disgraced Blatter to World Cup
Jun 22, 2018 - 03:04
Then we can get back to the games - until Putin pipes up to pat himself on the back again. Court documents show they were sentenced on Wednesday.

isis-killer-beheading-video-story-top Trump reverses family separation policy after tech, political backlash
Jun 22, 2018 - 02:39
It's unclear what happens if no changes to law or the settlement take place by the time families reach the detainment deadline. Photos of detention facilities holding migrant children under the Obama and Trump administrations bear striking similarities .