At present, the Food and Drug Administration is yet to approve medical marijuana. However, there is reason to hope that the highly anticipated approval of medical marijuana will come after the agency approved one product and three drugs derived from cannabis. The product is Epidiolex (cannabidiol), and the drugs are:
- Cesamet (nabilone)
- Marinol (dronabinol)
- Syndros (dronabinol)
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These are available only with a prescription written by a licensed health care provider. It is important to note that cannabis and other cannabis-derived products have not been approved even though they may be available in the market.
How Cannabis-Derived Products and Drugs Work
Epidiolex contains a purified form of cannabidiol. It is effective in the treatment of seizures caused by the Dravet or Lennox-Gastaut Syndromes. It has been approved for use by patients aged two years and above. The FDA found it safe and effective for use in treating these particular conditions only.
Marinol and Syndros have been approved for calming nausea induced by chemotherapy in cancer patients undergoing this form of treatment. It has also been approved for use to treat anorexia due to weight loss in HIV/AIDS patients. The two drugs contain an active ingredient that is known as dronabinol. This is a synthetic delta-9- tetrahydrocannabinol (THC). It is the psychoactive intoxicating component of cannabis or the cause of the high that cannabis users experience.
The third FDA-approved drug Cesamet has an active ingredient known as nabilone. Its chemical structure can be compared to that of THC, and it derived artificially. It has also been used for approval in treating nausea that cancer patients experience after a chemotherapy session.
Unallowed But in Use
The FDA is aware that there are unapproved drugs derived from cannabis available in the market and use. They are being used to treat a broad range of symptoms and conditions.
Patients, their families, and caregivers can be sure that cannabis and drugs derived from it have been approved only after rigorous testing for quality, efficiency, and safety. The drugs are also periodically tested to ensure that the right standards and quality are maintained once they are available on the market.
This cannot be said of those that do not have FDA approval. Although researchers and marketers may insist that they are safe and effective, their quality is unproven and unregulated. These pose serious, potentially fatal risks. The FDA has not reviewed the drugs through clinical trials that would vouch for the drugs’ safety and effectiveness for the purpose they are being used for.
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Working On It
When questioned about approving other cannabis products and drugs derived from it, the FDA has expressed understanding of the need to develop them to meet the needs of patients who would benefit from them. The agency has said that it is doing all it can to approve of using more products and drugs. It is doing this through programs such as:
- Priority Review
- Fast Track
- Accelerated Approval
- Breakthrough Therapy
The programs are designed to facilitate medical marijuana product development and expedite approval of the same. The FDA has also indicated that it has opened up access to statutory and regulatory provisions to avail the investigational products to patients with serious health conditions and have no alternative, comparable therapy. This may be because a patient has tried other treatment options with no success. They are intolerant of approved treatment options or do not satisfy eligibility criteria for clinical trials.
The FDA has reiterated that through on-going cannabis products and drugs approval procedures and the above programs, it supports the use of the same. The agency has also indicated interest and support for manufacturers that have the same agenda.
MMJ in Support
Medical Marijuana Doctors (MMJ) stands in support of the safe and effective use of cannabis products and drugs to treat health conditions. The MMJ Clinic helps patients get a recommendation for the use of the products and register with programs that offer them within their locality. Patients get a cannabis card to prove their registration and to help them access medical marijuana.
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MMJ doctors have licensed doctors who are registered as medical marijuana doctors in the states they operate in. They have an in-depth understanding of cannabis, including the use of its medicinally and any potential risks that would make it risky for a particular patient.
MMJ doctors are available in various locations, including Florida, Maryland, New York, Arizona, Montana, and Puerto Rico. Get in touch and find out if you or a loved one can benefit from the use of medical marijuana.