US health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use. The actual list price of Epidiolex has not been set, but has been estimated at $2,500 to $5,000 a month, significantly more expensive than other CBD-based medication made available through state-legal medical cannabis programs.
The medicinal acknowledgment of CBD should come as good news to marijuana startups eyeing the compound for consumer and medical consumption.
"Clinical development for these rare and severe conditions is essential, and today's news brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures".
"This is an important medical advance", FDA Commissioner Dr. Scott Gottlieb said in a statement Monday. "But it's also important to note that this is not an approval of marijuana or all of its components". The new drug is anticipated to become available to patients later this fall.
Epidiolex would also be the first approved therapy for DS, treatments for which are now limited to a combination of seizure medication and drugs to prevent emergencies.
The study also showed that Epidiolex is a safe treatment, with only seven patients dropping out of the trial due to side effects - six from the 20-mg group and one from the 10-mg group.
Epidiolex is created to treat two rare forms of childhood epilepsy.
Gottlieb emphasized that the approval of Epidiolex does not have any implications for the approval of marijuana as a medicine more broadly, but the move is still widely seen by the industry as a significant step towards acceptance of the cannabis plant. The FDA has previously sent warning letters to companies that hyped their products as cancer or Alzheimer's fighters. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions. "I really don't think [the FDA approval is] going to affect us much".
Before sales of Epidiolex can begin, the Drug Enforcement Administration must formally reclassify CBD into a different category of drugs that have federal medical approval.
That's according to Steve Fox, the director of VS Strategies, which was retained by GW Pharmaceuticals to assist with lobbying and public relations efforts.
Epidiolex is also the first prescription created to treat children with Dravet syndrome, according to the FDA's announcement. For instance, a clinical trial is underway to test whether CBD can be an effective treatment for people with post-traumatic stress disorder and alcohol use disorder. The agency is expected to make this classification within 90 days.
Italy's new government has banned on NGO migrant rescue ships from docking at its ports and urged Malta to take in the Lifeline. Last week, he refused to allow the Aquarius, a ship that picked up hundreds of people, to dock.
Iran is usually not part of the committee, which includes Russia, Saudi Arabia, the UAE, Oman, Kuwait, Algeria and Venezuela. That means the country has little to gain from a deal to raise OPEC output, unlike top oil exporter Saudi Arabia.
The policy sets up new guidelines for satellite design and operation, as well as tracking the growing amount of clutter in space. Air Force was created through the 1947 National Security Act, passed by Congress and signed into law by President Harry Truman.
Bairstow , on 30, skyed a drive off Tye but Marcus Stoinis failed to hold an extremely tough chance as he ran back from mid-on. In the intervening years, they have developed into the most exciting, destructive and successful one-day team in the world.
Freeing themselves of the Deng contract and renouncing rights. will give them enough space to do whatever they please. The Oklahoma City media reports that Thunder management is optimistic he will re-sign there.
John Moore/Getty ImagesA Honduran mother with her daughter shortly before they are separated at the US-Mexico border. CNN is looking into reports that these individuals are being turned away there, as well.
We just want to win as many games as possible and he just popped up with two goals that got us all three points. In contrast, England's Premier League is viewed as one of the world's most premier divisions.
Southampton's midfielder Tusan Tadic , has 51 caps and 13 goals for Serbia , and contributes a lot at the offensive end. Serbia secured victory despite striker Aleksandar Mitrovic missing a big chance in the second half.
Hareide's side kick-off their campaign in Saransk on Saturday, with Australia and tournament favourites France also in the pool. Hareide said in his post-match press conference of Leicester's Schmeichel: "He is acrobatic, he is a very quick goalkeeper".
Apple is also looking to increase the distance that AirPods can function away from an iPhone or iPad, the news service reported. Talking about the AirPods first, these wireless earphones will be able to feature noise-cancellation and water-resistance.
Iran , meanwhile, face Portugal on the same day needing a win to progress at the expense of Cristiano Ronaldo and Co. But Hierro, like Iniesta , has no intention of being the man who steered Spain to an unthinkable World Cup disaster.
Fox's share price was trading at $44 early on Wednesday morning, indicating investors believe a bigger bid is likely. Disney said it's raising its offer because Fox's value increased due to "tax reform and operating improvements".
Was Ronaldo fortunate to avoid red card against Iran?
Serbia must beat Brazil to qualify but a draw could see them through if the Swiss are beaten by Costa Rica by more than one goal . Belgium now have three yellow cards to England's two, meaning this could be a battle of discipline more than anything.
Hazard, Lukaku Goals Put Belgium in Control Against Tunisia
It was the second-earliest goal scored by a Belgium player at a World Cup after Leopold Anoul scored in the fifth minute in 1954. Belgium go into the second half with a narrow 2-1 lead, despite dominating for large spells of the first 45 minutes.
Cavs want to keep Kevin Love even if LeBron James leaves
If they can retain James and make a couple other moves to better their squad, they could be even more risky next season. But LeBron and the National Basketball Association don't work that way, so they have to do the next best thing.
Britain to increase health care spending
She said technology was "transforming how we engage with the NHS" and it can "improve the way care is delivered". It's right that we use that money to spend on our priorities, and the NHS is our number-one priority".
Google Think Salman is the 'Worst Bollywood Actor'?
Till now, Race 3 has grossed Rs 138.41 crore (nett Rs 106.47 crore) and Rs 55 crore in the worldwide markets. Deepika Padukone , Ranveer Singh, and Shahid Kapoor's Padmaavat maintains the top spot with Rs 114 crore.
China threatens tariffs on USA lobsters as business booms
The United States now dominates those industries, but Chinese government support could make it hard for USA companies to compete. United States carmakers, which have targeted China as a key growth market, are also expected to be hit by the bruising tariffs.