FDA Approves First Cannabis-Based Drug

Many parents already are giving children unregulated CBD formulations that are available in medical marijuana dispensaries in the many states where such operations are legal.

In a statement accompanying Monday's approval announcement, the FDA hastened to note that it's not signing off on the safety or medical utility of marijuana in general ― just this one compound and only for this limited use.

Like Dravet syndrome, Lennox-Gastaut syndrome also begins in childhood and causes multiple types of seizures. Under the Controlled Substances Act, marijuana is a Schedule I drug, meaning it has a high potential for abuse and no recognized medical goal (heroin, LSD, and ecstasy are also Schedule I drugs).

In clinical trials, children with Dravet syndrome who took Epidiolex experienced 39 percent fewer seizures; those with Lennox-Gastaut syndrome saw a 37 percent decrease. 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.

The FDA says this is the first drug approved in the USA that contains a purified substance derived from marijuana. However, the FDA has found that Epidiolex, when combined with other medications for epilepsy, does reduce seizures.

Epidiolex will be marketed by Greenwich Biosciences, a subsidiary of GW Pharmaceuticals.

A drug made from a derivative of marijuana has been approved for patients with certain forms of epilepsy.

Side effects included sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor quality sleep and infections. This is not only the first drug that contains substances from marijuana, but it is also the first drug aimed to treat Dravet syndrome.

Turkey's Erdogan Wins Presidential Election, Extends 15-Year Reign
Ince also complained that it was an unfair election but accepted Erdogan's victory during a news conference Monday. More than 110,000 government workers have also been dismissed under a state of emergency after the coup.

Ronaldo's Portugal kick out Morocco from World Cup
Portugal earned a narrow 1-0 win over Morocco on Wednesday, after Cristiano Ronaldo's early header proved to be the difference. Portugal now has four points and leads Group B ahead of the late match between Iran and Spain.

DHS Secretary Nielsen denies separation amounts to 'child abuse'
Mr Trump has derided that practice as "catch and release", arguing that numerous immigrants never appear for court proceedings. Multiple reports have also contradicted Nielsen's claim that asylum-seeking families are not being separated.

A major milestone Monday for use of marijuana for treatment of health ailments.

While there was initially some confusion about whether the Drug Enforcement Administration might block the sale of Epidiolex, given cannabis' status as a Schedule I substance, Epidiolex manufacturer GW Pharmaceuticals doesn't believe that will be the case.

This means Epidiolex, which will require a prescription from a doctor, will soon be available in pharmacies all across the nation. "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".

The FDA is not required to follow the advisory panel's advice but usually does. "I really don't think it's going to affect us much". Agency officials paved the way for the cannabis-based drug by defending its effects in a briefing document, writing, "In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders".

The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals.

Federal agencies have 90 days to determine the scheduling of Epidiolex.

The FDA's first approval of a cannabis-derived compound happened thanks to sound science, and it must proceed that way.

(Copyright © 2015. All Rights Reserved.)
 
Recommended

New Records & Milestones Cristiano Ronaldo Can Set in Russian Federation
Spain earned its first win at the 2018 World Cup on Wednesday, narrowly beating Iran 1-0 on a fortunate goal from Diego Costa . Mexico beat Germany (1-0): Mexico shocked the defending World Cup champions with a lone goal from rising star Hirving Lozano.

Trump Threatens Another $200 Billion in Chinese Tariffs as US Stocks Plunge
The drugstore chain and pharmacy benefits manager said it will start making home deliveries of prescriptions and other items. But Beijing's mention of "comprehensive measures" suggests that it would go beyond tariffs, said Jake Parker of the U.S.

Messi is not a leader, he is no Ronaldo, claims Petit
At the FIFA World Cup football this time, the superstar and Cristiano Ronaldo , the world's richest footballer, is on the run. Iceland held Argentina in 1-1 its opening match but needs to win its last Group D game after losing to Nigeria 2-0.

Federer enters final, regains world number 1 ranking
The dramatic yet comedic match had a lot of light moments, along with pristine shot making and oscillating levels of play. In his previous match, he had lost to Juan Martin del Potro in the Indian Wells final - in a third-set tiebreak.

First Lady Pays Surprise Visit to Migrant Children at Texas Detention Shelter
Trump said he supports the legislation, but it is still unclear if the bills the House plan to vote on have enough votes to pass. President Trump repeatedly, and falsely, blamed Democrats for the practice and said there was nothing he could do to end it.

U.S. withdrawal from UN Human Rights Council is regrettable
Dujarric said: "The secretary-general would want to see a United States that is involved and engaged throughout the U.N. system". Embassy there from Tel Aviv. "It is bad news, it is bad news for this Council, it is bad news I think for the United Nations ".

Costa Rica vs. Serbia - Football Match Report
Costa Rica and Serbia were drawing 0-0 at halftime in the opening World Cup Group E match in the Samara Arena on Sunday. The 34-year-old Ivanovic had matched Stankovic's record last Saturday in a 5-1 friendly win over Bolivia.

World Cup Fans Celebrating in Mexico City May Have Caused Artificial Earthquake
Manning the barricades is not a new idea for smaller countries hoping to upset the odds. "We are our harshest critics". Mexico's goalscoring hero Hirving Lozano has been backed to play in the Premier League by manager Juan Carlos Osorio.

Oppo unveils flagship Find X smartphone; India launch on July 12
With that being said, one big plus with the Find X is that Oppo has finally deemed the United States worthy to receive its phones. It also carries Huawei-inspired AI-enhanced object and scene detection feature that tweaks camera settings automatically.

No Narcotics In Anthony Bourdain's System When He Died
Brash and opinionated, he had spoken openly about his use of drugs and addiction to heroin earlier in his life. French prosecutors had previously said that all indications pointed to suicide by hanging.

Joy for Denmark as Peru beaten in World Cup opener
The 34-year-old went close to equalising when he sent a clever backheel wide with around 10 minutes to go. You have to try and overcome this kind of adversity. "He played very well".

Ronaldo and Portugal look to eliminate Morocco
Iran has been drawn in Group B of the World Cup in Russian Federation along with Portugal , Morocco and Spain . The game is live on both Viu TV (channel 99 ) and Now TV World Cup channels (618 and 619).

Nick Jonas and Priyanka Chopra's romance is Instagram official
Earlier this month, the Baywatch actress accompanied the Close hitmaker to his cousin Rachel Tamburelli's wedding in New Jersey. And in a new interview with People , Chopra discussed her future hopes, including whether or not she wanted to have kids.

Harley-Davidson to shift some production out of USA over European Union tariffs
Yet Harley-Davidson had previously warned that the escalating tariffs spat would lead to an even higher burden for the company. Lovely said Harley and other companies face retaliatory tariffs in Europe and elsewhere if they try to export products.

(Updated) Senegal punish Polish errors to win 2-1 in Group H
The Terranga Lions coached by former captain, Aliou Cisse , produced an impressive performance to defeat Poland 2-1 on Monday . The other aspect of Senegal's win was restricting the vaunted Poland attack to just four shots on target in the entire match.


More News

News
More News