2012 Sativex awaits FDA approval

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2012 Sativex awaits FDA approval - THE SPECTRUM & DAILY NEWS FROM THE FRONT PAGE...
THE SPECTRUM & DAILY NEWS FROM THE FRONT PAGE Monday, January 23, 2012 A3 S R X I Marijuana-based drug waits for FDA approval By Lisa Left Associated Press SAN FRANCISCO A quarter-century after the U.S. Food and Drug Administration approved the first prescription drugs based on the main psychoactive ingredient in marijuana, additional medicines derived from or inspired by the cannabis plant itself could soon be making their way to pharmacy shelves, according to drug companies, small biotech firms and university scientists. A British company, GW Pharma, is in advanced clini- cal trials for the world's first pharmaceutical developed from raw marijuana instead of synthetic equivalents a mouth spray it hopes to market in the U.S. as a treatment for cancer pain. And it hopes to see FDA approval by the end of 2013. Sativex contains marijuana's two best known components delta 9-THC and cannabidiol and already has been approved in Canada, New Zealand and eight European countries for a different usage, relieving muscle spasms associated with multiple sclerosis. FDA approval would represent an important milestone in the nation's often uneasy relationship with marijuana, which 16 states and the District of Columbia already allow residents to use legally with doctors' recommendations. The U.S. Drug Enforcement Administration categorizes pot as a dangerous drug with no medical value, but the availability of a chemically similar prescription drug could increase pressure on the federal government to revisit its position and encourage other drug companies to follow in GW Pharma's footsteps. "There is a real discon V ET - nect between what the public seems to be demanding and what the states have pushed for and what the market is providing," said Aron Lichtman, a Virginia Commonwealth University pharmacology professor and president of the International Cannabinoid Research Society. "It seems to me a company with a great deal of vision would say, 'If there is this demand and need, we could develop a drug that will help people and we will make a lot of money.'" Possessing marijuana still is illegal in the United Kingdom, but about a decade ago GW Pharma's founder, Dr. Geoffrey Guy, received permission to grow it to develop a prescription drug. Guy proposed the idea at a scientific conference that heard anecdotal evidence that pot provides relief to multiple sclerosis patients, and the British government welcomed it as a potential way "to draw a clear line between recreational and medicinal use," company spokesman Mark Rogerson said. In addition to exploring new applications for Sativex, the company is developing drugs with different cannabis formulations. "We were the first ones to charge forward and a lot of people were watching to see what happened to us," Rogerson said. "I think we are clearly past that stage." In 1985, the FDA approved two drug capsules containing synthetic THC, Marinol and Cesamet, to ease side-effects of chemotherapy in cancer patients. The agency eventually allowed Marinol to be prescribed to stimulate the appetites of AIDS patients. The drug's patent expired last year, and other The drug Sativex contains marijuana's two best known components delta 9-THC and cannabidiol and has been approved in Canada, New Zealand and eight European countries for relieving muscle spasms associated with multiple sclerosis, gw PHARMACEUTICALS ZAP U.S. companies have been developing formulations that could be administered through dissolving pills, creams and skin patches and perhaps be used for other ailments. Doctors and multiple sclerosis patients are cautiously optimistic about Sativex. The National Multiple Sclerosis Society has not endorsed marijuana use by patients, but the organization is sponsoring a study by a University of California, Davis neurologist to determine how smoking marijuana compares to Marinol in addressing painful muscle spasms. "The cannabinoids and marijuana will, eventually, likely be part of the clinician's armamentarium, if they are shown to be clinically beneficial," said Timothy Coetzee, the society's chief research officer. "The big unknown in my mind is whether they are clearly beneficial." Opponents and supporters of crude marijuana's effectiveness generally agree that more research is needed. And marijuana advocates fear that the government will use any new prescription products to justify a continued prohibition on marijuana use. "To the extent that companies can produce effective medication that utilizes the components of the plant, that's great. But that should not be the exclusive access for people who want to be able to use medical marijuana," Americans for Safe Access spokesman Kris Hermes said. "That's the race against time, in terms of how quickly can we put pressure on the federal government to recognize the plant has medical use versus the government coming out with the magic bullet pharmaceutical pill." Legislature Continued from A1 "A lot of individuals have been shutout of the conversation," said House Minority Leader David Litvack, D-Salt Lake City. "Our hope is that the recommendations will bring new voices to the table." One problem with current alcohol regulation in Utah is that it's "like a parent and a child," Litvack said. Instead of working with those who serve alcohol to prevent problems, the state simply passes laws and punishes license holders. The Department of Alcoholic Beverage Control will most likely be restructured after a series of negative audits and the resignation of the agency's director this summer, which followed the discovery of contracts for office supplies with a company owned by the director's son. There is also a growing public outcry for more bar licenses, which can take months to secure since they are based on quotas and population and often aren't even available to all applicants. Simultaneously, a growing number of conservative lawmakers are questioning whether the state should even be involved in the liquor business, leading to legislation aimed at privatizing state-run outlets. Still, the Utah Legislature is dominated by Republicans who are almost exclusively LDS Vote 4r your cvYoHte! 'JA ) janna r- members and abstain from drinking alcohol. Historically, church leaders have been involved in crafting the state's liquor policy and seldom support liberalizing laws. Republican leaders echo that sentiment, especially in the Senate. "If people are going to try to increase availability, it better not increase consumption, DUIs or expose more children to drinking," said Senate President Michael Waddoups, R-Taylorsville. While liquor laws may grab the headlines this session, the budget remains a top priority. Unlike previous years, state agencies will not be asked to cut their budgets, and a $280 million surplus means there will likely be enough money to fund growth in public education and give state employees and teachers a small raise. After that, however, the pickings will be slim. "We finally have a little bit of revenue growth, which actually makes it harder," said House Speaker Becky Lockhart, R-Provo. "When you have nothing, you can say no to everyone. When you have a lot, you can say yes to a lot of people. But this year, we have to prioritize. We'll talk about a lot of things, but we only have limited resources.' Waddoups said most proposals will have to be funded internally by agencies, which would force cuts somewhere else in the agency budget. The finalists will compete at 7:00 PM Jan. 24th & 25th at the One of the few exceptions may be some education initiatives that increase technology in the classroom which have support in both chambers as well as from Gov. Gary Herbert. The goal is to get more high school graduates into higher education. "There's a growing awareness of the correlation between education and economic development," Herbert said. "We've got to make sure our education is connecting with what the market needs." Last year, the dominant issue was immigration reform with the end result being the passage of a package of bills that balanced enforcement measures with a guest worker program. This year, the debate is expected to continue, but it is likely to be more focused on tweaks to last year's bills. The reluctance to revisit the bills is due, at least in part, to a pending court case on the enforcement angle and a delayed implementation date for the guest worker program. But there is also a feeling among leaders and sponsors that the debate last year was sufficient and other issues should take precedence. "I don't want this session to be about immigration," said Rep. Stephen Sandstrom, R-Orem, the sponsor of the enforcement measure in 2010. "We have a lot of other pressing needs, especially education and growing the economy." Wild

Clipped from
  1. The Daily Spectrum,
  2. 23 Jan 2012, Mon,
  3. Other Editions,
  4. Page 3

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  • 2012 Sativex awaits FDA approval

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