How Did the Synthetic Medical Marijuana Drug Marinol Get Approved By the FDA?

Marinol was approved by the FDA as a synthetic medical marijuana THC. It comes in oral form to reduce chemotherapy nausea and in addition assists with increasing appetite in AIDS sufferers. The debate between smoking natural marijuana versus utilizing oral Marinol is robust. This article’s purpose is to give the basics on the FDA approval process using Marinol as an example.

In the US, the Food and Drug Administration decides if a drug is safe for human consumption in the marketplace. How does it get there? A clinical trial is conducted and is typically sponsored by the drug sponsor.

Typically, the sponsor is a big drug company. Some people consider drug companies poorly because of the monies they make, but it truly costs a ton to pay for a clinical studies. A large amount of drug breakthroughs emanate from clinical trials, including chemotherapy breakthroughs along with less important breakthroughs like Viagra or Cialis.

The National Institute of Health also funds commercial development of drugs for severe diseases such as AIDS, Cancer, epilepsy, and Multiple Sclerosis. 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 you had a loved one dying of cancer, you might think differently about a life extending medication that had its origin being studied in mice originally. When animals are studied, this is the preclinical drug phase.

Let’s say a researcher is investigating appetite in mice. He or she may do this by inducing a disease state in mice that decreases 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.

What’s the time frame on all this? Typically it takes 5 years. If it is complicated, it could take longer. And in addition, if it is a rare disease then it could take quite a long time to enroll enough patients.

How many medications get approved? About 20% actually secure FDA approval. The average cost is $200 to $600 million dollars, so these drug trials are extremely risky.

Subsequent to Phase 3, the FDA gets a new drug application for marketing approval. The average time for FDA review is 1.25 years. Since 1992 the FDA has been allowed to charge fees so it has more staffing and the review time has reduced from 2 years to 15 months.

The Food and Drug Administration then gives an indicated approval. If the manufacturer desires a new indication, another application process is needed. Marinol happens to be the only prescription medication in the US which is a synthetic THC. In only two years, Marinol moved from Investigation New Drug status to approval.

That first approval was in 1985 for vomiting and nausea affiliated with chemotherapy for cancer. The drug manufacturer applied and received FDA approval in 1992 for AIDS wasting.

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