Marijuana-based drug gets positive review from FDA

first_img Trending Now: Conry and other researchers say it’s not yet clear why CBD reduces seizures in some patients.GW Pharmaceuticals makes its drug from cannabis plants that are specially bred to contain high levels of CBD. It’s seeking approval for two rare forms of childhood epilepsy — Dravet and Lennox-Gastaut syndromes.Common side effects included diarrhea, vomiting, fatigue, and sleep problems. FDA reviewers flagged a more serious issue with potential liver injury, but said doctors could manage the risk by monitoring patients’ enzyme levels.— Matthew Perrone Associated Press WASHINGTON — A closely watched medicine made from the marijuana plant reduces seizures in children with severe forms of epilepsy and warrants approval in the United States, health officials said Tuesday.British drug maker GW Pharmaceuticals is seeking permission to sell its purified form of an ingredient found in cannabis — one that doesn’t get users high — as a medication for rare, hard-to-treat seizures in children. If successful, the company’s liquid formula would be the first government-approved drug derived from the cannabis plant in the U.S.The Food and Drug Administration’s approval would technically limit the treatment to a small group of epilepsy patients. But doctors would have the option to prescribe it for other uses and it could spur new pharmaceutical research and interest into other cannabis-based products. Man-made versions of a different marijuana ingredient have previously been approved for other purposes.advertisement About the Author Reprints By Associated Press April 17, 2018 Reprints HealthMarijuana-based drug gets positive review from FDA DEA decision keeps major restrictions in place on marijuana research Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Related:center_img Related: Epidiolex is essentially a pharmaceutical-grade version of cannabidiol, or CBD oil, which some parents have used for years to treat children with epilepsy. CBD is one of more than 100 chemicals found in the cannabis plant and it doesn’t contain THC, the ingredient that gives marijuana its mind-altering effect.CBD oil is currently sold online and in specialty shops across the U.S., though its legal status remains murky. 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.A doctor who treats children with epilepsy says it’s important to have an FDA-approved version of CBD.“I think it needs to be approved because everyone is using it across the internet without knowing the safety … and no one is watching the interactions with other drugs,” said Dr. Joan Conry, of Children’s National Health System in Washington, who was not involved in the studies. FDA The FDA posted its review of the experimental medication Epidiolex ahead of a public meeting Thursday when a panel of outside experts will vote on the medicine’s safety and effectiveness. It’s a non-binding recommendation that the FDA will consider in its final decision by late June. In a first, scientists show a marijuana component reduces seizures for some with epilepsy Patients taking the treatment had fewer seizures, according to the FDA’s internal review posted online. Scientists concluded that GW Pharmaceuticals’ submission “appears to support approval” despite some potential side effects including risks of liver injury.advertisement More than two dozen states allow marijuana use for a variety of ailments, but the FDA has not approved it for any medical use. In 2016, the agency recommended against easing federal restrictions on marijuana. The U.S. continues to classify marijuana as a high-risk substance with no medical use, alongside other illicit drugs like heroin and LSD.For years, desperate patients and parents have pushed for wider access to medical marijuana products for a host of conditions including pain, post-traumatic stress disorder and epilepsy, with only anecdotal stories and limited studies on their side.But studies conducted by GW Pharmaceuticals have begun to change that picture.Across three studies involving more than 500 patients, Epidiolex generally cut the number of monthly seizures by about 40 percent, compared with reductions between 15 and 20 percent for patients taking a dummy medicine.Most patients in the study were already taking at least three other medications to try and control their seizures. Tags pharmaceuticalspolicylast_img read more

Life After 100

first_img Email Stay Connected with the Daily Roundup. Sign up for our newsletter and get the best of the Beacon delivered every day to your inbox. One hundred years ago, the United States was in the midst of the Great War. The average life expectancy was 48 for a man and 51.1 for a woman; $1 could buy two gallons of milk, a dozen eggs and a pound of coffee; and less than half of the nation’s population lived in urban areas.“It’s amazing to think of all the changes our centenarians have witnessed over the last century or more,” Montana Lt. Gov. Mike Cooney said, addressing an audience gathered for the 49th annual Governor’s Conference on Aging at the Red Lion Hotel in Kalispell.Go back in time a century, and fans of the University of Montana football program will be disappointed — the 1917 Griz won just a single game during their season at Dornblaser Field. That same year, the first two women were elected to Montana’s state legislature, Maggie Smith Hathaway and Emma Ingalls, while just 670,000 people occupied the Treasure State.It’s a bygone era, to be sure.But for a clutch of western Montana centenarians, it was the era they were born into, and on Sept. 7 they were honored for their longevity.A group of 11 Montana residents who are 100 years or older gathered for the conference this week, an event sponsored by the Department of Public Health and Human Services to recognize the achievements of Montana’s senior population, as well as the pressures that the graying of the state places on the demand for medical services.According to the DPHHS, in 2025, Montana is expected to be home to more than 3,000 residents over the age of 100, up from 175 in 2010.According to the U.S. Census Bureau, more than 53,300 centenarians were living in the United States in 2010, compared to around 32,000 in 1980. What used to be unusual, living to be 100 years old, is expected to become increasingly common as modern science continues to develop methods for treating diseases, optimizing health and identifying genes that affect longevity.Oscar Baertsch, age 102, of Polson, still lives in the home he built on the south end of Flathead Lake, and jokingly attributed his longevity to a strict regimen of whiskey, cigarettes, Copenhagen, and hard work. (In reality, he chalks it up to hereditary luck, noting that several family members lived well into their 90s).On Aug. 17, Helen Self, of Missoula, celebrated her 108th birthday with little fanfare, but recalls marking her 100th milestone with a Harley Davidson motorcycle ride.Self still lives at home with her granddaughter, Diane Gunter, a licensed foster parent, and several children. Gunter is a small business owner, and has been a licensed foster parent since 1988. Self has lived with Gunter since 2001, and until last year it was Self who handled a majority of the cooking for the household.Cooney noted that Self’s story will become more commonplace as people continue living longer, and said the governor’s office is committed to making the challenges of dementia and Alzheimer’s in Montana’s senior population a priority.last_img read more