In February 2017, the US Food and Drug Administration (FDA) approved the Abilify Mylan Pharmaceuticals drug, also known as dronabinol, for the treatment of multiple sclerosis (MS).
The use of this medication is restricted to people with MS who are not benefited by other therapies. However, the approval of dronabinol for this use is just the latest in a series of recent approvals for the use of investigational medications in treating other diseases. As a result, thousands of patients are now able to benefit from these medications as well.
These approvals come on the heels of the FDA’s 2011 decision to revoke its approval of Sativex, a cannabis-based medicine with clinical studies showing it effective in the treatment of MS-related pain and spasms. Since then, additional illnesses for which the FDA has approved the use of medicinal cannabis include:
- Cancer
- Anorexia Nervosa
- Opioid Addiction
- Sickle Cell Anemia
- Alzheimer’s Disease
- Parkinson’s Disease
- Rheumatoid Arthritis
- Multiple Sclerosis
Viagra’s Resurgence
It started with the introduction of sildenafil (more commonly known as Viagra) in the late 1990s. Since then, numerous studies have shown the effectiveness of this medication in treating erectile dysfunction (ED). In 2014, the FDA even approved a generic version of Viagra for this use.
However, Viagra’s popularity goes beyond ED treatment. The American Association of Sexuality Educators (4A’s) estimates that roughly 60 million men worldwide are taking the drug for a variety of other conditions.
These include low libido, performance anxiety, and premature ejaculation (PE). In fact, the most popular non-ED use of Viagra is to treat low libido and performance anxiety. It is also frequently prescribed to men with premature ejaculation problems.
Dronabinol’s Effect On MS
MS is a disease that affects the central nervous system and results in damage to the brain and spinal cord. The most common symptoms of this disease are numbness or tingling in the extremities, vision problems, and poor muscle control. However, the disease can have varied effects, which are determined by the specific part of the brain that is affected.
Dronabinol is a synthetic cannabinoid that is derived from the plant marijuana. It has a chemical structure that is very similar to that of tetrahydrocannabinol (THC), the active ingredient in cannabis. Thus, this medication is often referred to as a cannabinoid medication.
The exact mechanism of action of dronabinol in MS is not known. However, there is evidence to suggest that it may interfere with some of the immune system functions. It has also been proposed that dronabinol may reduce inflammation in the central nervous system. In addition, dronabinol is believed to have significant anti-nociceptive (anti-pain) properties. Finally, some studies have suggested that dronabinol may alter the way the body processes sensory information. This may have a positive effect on the symptoms of MS, as many of the disease’s symptoms are related to sensory issues (e.g., numbness, tingling, and vision problems).
One of the issues with early trials of dronabinol was the absence of a control group. This means that it is difficult to know whether the positive effects of dronabinol are a result of the drug itself or of the disease’s natural course.
FDA’s Uphill Battle With Cannabis
Before Sativex, the FDA’s position on cannabis was rather complex. On the one hand, the agency had accepted the results of several clinical studies suggesting that cannabis may be an effective treatment for a variety of diseases (e.g., nausea from chemotherapy, appetite loss in people with HIV/AIDS, and pain).
On the other hand, the agency accepted the conclusions of a 2001 Institute of Medicine (IOM) report, which stated that there was no evidence to recommend the widespread use of cannabis for medical purposes. The IOM report also stated that there was insufficient evidence to determine whether cannabis is or is not effective in the treatment of any illnesses.
As a result, in 2011, the FDA approved the use of Sativex, a cannabis-based medicine, for the treatment of MS-related pain and spasms. However, the agency soon realized that it had made an error in approving this medication without a control group.
This decision was a major setback for the agency, which had fought an uphill battle against cannabis in the past. In fact, just two days after Sativex was approved, the FDA issued an enforcement notice, stating that it has “no choice but to legally prohibit the manufacture and sale of Sativex in the United States.”
The reason the agency gave for imposing this ban was that Sativex contains THC, which is an illegal psychoactive substance under federal law. Furthermore, even though CBD (a non-psychoactive, anti-inflammatory compound found in cannabis) is approved for use in medical products, including MS treatment, it, too, is considered a controlled substance under federal law because it has a high potential for abuse.
The good news is that the FDA has not prohibited the use of Sativex in the United States. Instead, it has imposed a number of restrictions on how the medication can be prescribed and who can receive it. It is important to note that these restrictions only apply to people with MS in the United States. As a result of the FDA’s actions, patients around the world, including those in the United States, are now able to benefit from the drug.
These recent approvals of dronabinol for the treatment of other diseases and Sativex for the treatment of MS demonstrate the ever-evolving relationship between the FDA and medicinal cannabis. While the FDA has accepted the potential of medical cannabis for treating certain illnesses, it remains firmly in the camp of prohibition when it comes to recreational cannabis use. As a result, it has continued to fight an uphill battle against cannabis, both clinically and legislatively. However, in the face of aggressive lobbying and massive public support, the FDA has recently begun to soften its position on cannabis. It now accepts that some degree of medical use is acceptable and that it may be possible to regulate this industry in a way that is beneficial to patients.
Clinical Trials For Multiple Sclerosis
Due to the FDA’s approval of medical cannabis for treating MS-related pain and spasms, a number of major pharmaceutical companies have developed compounds that are, in some way, similar to dronabinol. These compounds are now being tested in clinical trials for the treatment of MS. If these trials prove successful, we may see multiple sclerosis treated with a medication instead of a surgery or a chemotherapy.
This is a far better option for patients, as research has shown that up to 75% of people with MS will experience at least one adverse effect resulting from a treatment, such as chemotherapy or a corticosteroid. In addition, these medications may be harmful to one’s health and cause additional side effects that may be difficult to manage. For example, a chemotherapy treatment for MS may be highly toxic to the liver and cause severe damage. Furthermore, many of these drugs are expensive, which limits their accessibility.
Why Are Pharmaceutical Companies Testing This Route?
The big question is why are pharmaceutical companies developing these medications in the first place? The answer is simple. Patients with MS experience a wide range of symptoms, and many of these symptoms, such as cognitive issues and pain, can be controlled (at least to some extent) with current medications. However, as noted above, there are several adverse effects associated with these medications, which is why they are being tested as a safer alternative.
The other major reason these companies are exploring this route is due to the lack of a cure for MS. Many people with this disease experience a varying degree of improvement with different medications. Thus, they have to keep trying different drugs to find the ones that work best for them.