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Post by akemp3000 on Jun 25, 2018 16:03:33 GMT -5
(Reuters) - The U.S. health regulator approved GW Pharmaceuticals Plc’s epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the country and opening floodgates for more research into the medicinal properties of cannabis.
Maybe this helps RLS. Andrea Leone-Bay is too talented to work with them without reason.
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Post by tiberious on Jun 25, 2018 16:07:57 GMT -5
(Reuters) - The U.S. health regulator approved GW Pharmaceuticals Plc’s epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the country and opening floodgates for more research into the medicinal properties of cannabis. Maybe this helps RLS. Andrea Leone-Bay is too talented to work with them without reason. Question... could GWPH's newly approved API be better served via Technosphere delivery? Dosing more accurate? Speed of onset improved?
Could GWPH use a better delivery platform?
I read the GWPH approval news today and while encouraging they still need follow-on DEA approval and there is no timeline according to DEA comment regarding same. |
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Post by peppy on Jun 25, 2018 16:12:50 GMT -5
(Reuters) - The U.S. health regulator approved GW Pharmaceuticals Plc’s epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the country and opening floodgates for more research into the medicinal properties of cannabis. Maybe this helps RLS. Andrea Leone-Bay is too talented to work with them without reason.you know I am hoping beyond hope this is the case.   |
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Post by mnholdem on Jun 25, 2018 17:08:55 GMT -5
Ironically, it's easier for a foreign pharmaceutical company to gain access to the U.S. market than it is for domestic companies, largely because of federal laws governing cannabis production and interstate transportation. Some of those laws are starting to be challenged but the foreigners have a distinct advantage. Incidentally, GW Pharmaceuticals is based in the U.K.
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Post by peppy on Jun 25, 2018 17:19:49 GMT -5
Ironically, it's easier for a foreign pharmaceutical company to gain access to the U.S. market than it is for domestic companies, largely because of federal laws governing cannabis production and interstate transportation. Some of those laws are starting to be challenged but the foreigners have a distinct advantage. Incidentally, GW Pharmaceuticals is based in the U.K.
How to schedule a drug. 1. congress signs it into law or2. petition filed with the attorney general, conducts an independent review. - petition goes to health and human services, an eight point review; 5parts scientific in nature, 3 parts specifically focused on abuse. - Health and human services sends it's findings and rescheduling recommendations back to the attorney general -attorney general reviews and if the recommendation was to reschedule, the attorney general office can initiate the rule making process. to reschedule - proposed rule, public notice and comment, revisited rules, published final rules. |
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Post by mnholdem on Jun 25, 2018 17:30:43 GMT -5
Even as several states and Washington, DC, allow marijuana, the federal government still strictly prohibits pot. Under the scheduling system, the federal government classifies marijuana as a schedule 1 drug, meaning it's perceived to have no medical value and a high potential for abuse. The classification puts marijuana in the same category as heroin and a more restrictive category than schedule 2 drugs like cocaine and meth.
The big distinction between schedule 1 and 2 substances, instead, is whether the federal government thinks a drug has medical value. The DEA says schedule 2 substances have some medical value and schedule 1 substances do not, so the latter receive more regulatory scrutiny even though they may not be more dangerous. It may be helpful to think of the scheduling system as made up of two distinct groups: nonmedical and medical. The nonmedical group is the schedule 1 drugs, which are considered to have no medical value and high potential for abuse. The medical group is the schedule 2 to 5 drugs, which have some medical value and are numerically ranked based on abuse potential (from high to low).
There have been many calls to reschedule marijuana, but they've run into a serious hurdle: To date, there have been no large-scale clinical trials on marijuana. Those kinds of studies are traditionally required to prove a drug has medical value to the federal government. But these studies are also much more difficult to conduct when a substance is strictly regulated by the federal government as a schedule 1 drug. So pot is essentially trapped in a catch-22: It likely needs a large-scale clinical trial to be rescheduled, but those trials are going to be much harder to conduct until it's reclassified.
Source: www.vox.com/cards/marijuana-legalization/marijuana-schedule
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Post by brotherm1 on Jun 25, 2018 22:10:35 GMT -5
Well, at least I don’t think they will have any problem finding study participants for a large scale trial.
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Post by peppy on Jun 25, 2018 22:22:22 GMT -5
Well, at least I don’t think they will have any problem finding study participants for a large scale trial. I see the humor. In the USA Marijuana is government grown in Mississippi, on some university of Mississippi property. if the government approves the endpoint, the government supplies the marijuana/cannabis from their facility to be used in the study. catch 22. The government will not/has not approved a study with a positive end point. The end. |
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Post by madog365 on Jun 26, 2018 8:53:53 GMT -5
(Reuters) - The U.S. health regulator approved GW Pharmaceuticals Plc’s epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the country and opening floodgates for more research into the medicinal properties of cannabis. Maybe this helps RLS. Andrea Leone-Bay is too talented to work with them without reason. It's been said that RLS is working on inhaled dronabinol, which is a synthetic form of THC. What was approved is the real deal (of CBD though) not a synthetic version. RLS seems to be directly competing with Insys, who are also developing a dronabinol inhalation alternative. www.insysrx.com/products/in-development |
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Post by matt on Jun 26, 2018 8:59:31 GMT -5
FDA has been pretty clear on what they will, and will not, approve. Marijuana contains over 80 active chemical substances, and all drug approvals are for particular active ingredients. The drug just approved this week refined a single chemical from marijuana and then refined and purified it until it was the only one left and FDA approved that chemical, not marijuana in general.
A huge part of any drug application is the ADME and CMC sections, which outline the absorption, dosing, metabolism and excretion of every active substance, and the chemistry, manufacturing, and controls used to produce a drug. If the manufacturer cannot demonstrate what the active ingredient is, or cannot prove what dose is given to the patient, FDA is not going to approve the drug. There is so much variability in basic marijuana plants, and so many active substances, don't expect to see an approval of pot. Specific substances processed and refined from pot, definitely possible.
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