First FDA-approved drug made from marijuana has N.J. ties

FDA approves first cannabis-based drug

FDA approves first cannabis-based drug

CBD oil is now sold online and in specialty shops across the USA, though its legal status remains murky. "Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA's drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients".

For those who have long argued that cannabis offers medical benefits, the FDA approval represents a milestone, "a recognition that the plant is a rich source of compounds which have potential therapeutic activity", Justin Gover, chief executive of GW Pharmaceuticals, the London-based company that developed the drug, said in an interview last week.

Even though 16 percent of trial participants experienced unwelcome side effects, such as diarrhea, vomiting and abnormal liver function, FDA officials and an advisory panel unanimously recommended its approval. A published study in the Journal of the American Medical Association (JAMA) showed tremendous variability in 84 CBD products tested.

There are likely to be drug interactions, she said, but "that's not uncommon for antiepileptic medications", and she noted that this could affect the effectiveness of the medication.

Epidiolex was approved for patients age 2 and older who suffer from Lennox-Gastaut and Dravet syndromes.

"I hope patients have conversations with their physicians about whether this product (Epidiolex) provides them with treatment they have been looking for with other unapproved products", said Douglas Throckmorton, deputy director of regulatory programs at the FDA's Center for Drug Evaluation and Research. Most producers say their oil is made from hemp, a plant in the cannabis family that contains little THC and can be legally farmed in a number of states for clothing, food and other uses.

The FDA previously issued warnings to CBD producers that claimed their products could treat specific diseases, such as cancer or Alzheimer's.

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A drug made from a derivative of marijuana has been approved for patients with certain forms of epilepsy. British drugmaker GW Pharmaceuticals expects the oral solution to hit the market this fall.

She says 17 doctor-prescribed drugs didn't help her son. This status has stifled rigorous research, because the federal government will not pay for it.

Vivian's parents, Brian and Meghan Wilson, elevated the shortcomings of the state's medicinal marijuana program and helped pass a law that led to the availability of a wide range of strains. "We want the whole-plant extracts that our kids are using and that have worked for them for years".

As a result, Epidiolex's launch remains at the discretion of the DEA which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, which would allow GW to begin selling it. And the company plans to continue importing the medicine, bypassing onerous US regulations on manufacturing restricted substances.

A reclassification is expected within 90 days, according GW Pharmaceuticals.

The European Medicines Agency is expected to rule on the therapy in early 2019.

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