How Does The FDA Approve A Synthetic Marijuana Drug Like Marinol?
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Marinol is a medication, FDA approved, that is a fake THC. It is available in oral form to reduce nausea due to chemo and also assists with appetite stimulation for AIDS sufferers. The debate between oral Marinol and smoking arizona medical marijuana for these issues is substantial. The purpose of this article is to provide an overview of the FDA approval process. Patients who opt for marijuana in AZ need an AZ Marijuana Card.
In the United States, the FDA decides if a drug is ok and safe for human consumption in the market. How does it get there? A clinical trial is conducted and is typically sponsored by the drug sponsor.
A large part of the time, the pharmaceutical company is that sponsor. Some people tend to snub their noses at these companies, but it takes deep pockets to fund modern clinical trials. A lot of groundbreaking meds emanate from clinical trials, including chemo breakthroughs along with less important drugs like Viagra.
The NIH additionally funds drug development for diseases such as Cancer, epilepsy, AIDS, and MS. It was through one of these programs that Marinol was invented and studied.
Before a drug ends up in human testing, it is often tested in animals. Animal rights groups do not like this one bit, but it is reality. If your loved one was dying of cancer, you might consider differently about lengthening life with a medication that had its origin being studied in mice. When animals are studied, this is the preclinical drug phase.
Let’s say a researcher is investigating appetite in mice. This may be done by inducing a disease into mice that reduces appetite. Then the mice are either given the investigational drug or whatever is considered the “Gold Standard” for increasing appetite. If the investigational drug works in the study, the drug maker submits and Investigational New Drug application to the FDA. The FDA then has a month to either contest the IND, and if not the drug maker may start testing in human beings.
There are typically 3 phases in clinical trials. In Phase 1 the drug is given to healthy volunteers to make sure it is safe and to determine dosing. Phase 2 then is almost like a Pilot Study with patients who have the condition intended for treatment receiving the medication. Safety and side effects are watched. Phase 3 involves a large group of patients confirming efficacy.
How long does all this take? On average, an unbelievable 5 years. Complicated drugs may take a lot longer. Also, if the condition is rare, it may take a while to enroll enough patients.
How many drugs make it through? About one in five drugs that start the process secure FDA approval. Considering it costs $200 to $600 million to get a drug through the 3 phases, these trials are risky.
After Phase 3, a New Drug Application is submitted to the FDA for marketing approval. It then takes an average of 1.25 years for the FDA to complete its review. Since 1992 when the FDA was allowed to charge fees it has allowed more staffing and the time for review has dropped from 2 years to 15 months.
At that point the FDA approves the drug for one indication. If the drug maker wants to add an additional indication, there is another application process. Marinol is the only medical marijuana arizona based prescription medicine available in the US. Marinol moved from Investigational New Drug status to approval in only two years, much less than average.
Tags: arizona medical marijuana, fda approval, marinol, medical marijuana arizona
