- What is Marinol?
- How much does Marinol cost?
- What’s the difference between Marinol and marijuana?
- Why do people use medical marijuana?
- Do Marinol and marijuana work for pain?
- What about for appetite and nausea?
- What’s coming?
- Marijuana Pill May Be Better For Pain Relief
- The Comprehensive Guide to Marinol (Dronabinol) [What It’s Used for]
- A Brief History of Marinol
- Big Pharma and Cannabinoids
- What Is Marinol Used for?
- Marinol Research
- Is Marinol Better Than Marijuana?
- Final Thoughts on Marinol
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following serious adverse reactions are described below and elsewhere in the labeling.
- Neuropsychiatric Adverse Reactions
- Hemodynamic Instability
- Paradoxical Nausea, Vomiting, and Abdominal Pain
Studies of AIDS-related weight loss included 157 patients receiving MARINOL at a dose of 2.5 mg twice daily and 67 receiving placebo. Studies of nausea and vomiting related to cancer chemotherapy included 317 patients receiving MARINOL and 68 receiving placebo. In the tables below is a summary of the adverse reactions in 474 patients exposed to MARINOL in studies.
Studies of different durations were combined by considering the first occurrence of events during the first 28 days.
A cannabinoid dose-related “high” (easy laughing, elation and heightened awareness) has been reported by patients receiving MARINOL in both the antiemetic (24%) and the lower dose appetite stimulant clinical trials (8%). The most frequently reported adverse experiences in patients with AIDS during placebo-controlled clinical trials involved the CNS and were reported by 33% of patients receiving MARINOL. About 25% of patients reported a CNS adverse reaction during the first 2 weeks and about 4% reported such a reaction each week for the next 6 weeks thereafter.
Common Adverse Reactions
The following adverse reactions were reported in clinical trials at an incidence greater than 1%.
|System Organ Class||Adverse Reactions|
|Cardiovascular||Palpitations, tachycardia, vasodilation/facial flush|
|Gastrointestinal||Abdominal pain*, nausea*, vomiting*|
|Central Nervous System||Dizziness*, euphoria*, paranoid reaction*, somnolence*, thinking abnormal*, amnesia, anxiety/nervousness, ataxia, confusion, depersonalization, hallucination|
|* Actual incidence 3% to 10%|
Less Common Adverse Reactions
The following adverse reactions were reported in clinical trials at an incidence less than or equal to 1%.
|System Organ Class||Adverse Reactions|
|General||Chills, headache, malaise|
|Cardiovascular||Hypotension, conjunctival injection|
|Gastrointestinal||Diarrhea, fecal incontinence, anorexia, hepatic enzyme elevation|
|Central Nervous System||Depression, nightmares, speech difficulties, tinnitus|
|Respiratory||Cough, rhinitis, sinusitis|
The following adverse reactions have been identified during post-approval use of dronabinol capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General disorders and administration site conditions: Fatigue
Hypersensitivity reactions: Lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, throat tightness
Injury, poisoning and procedural complications: Fall
Nervous system disorders: Seizures , disorientation, movement disorder, loss of consciousness
Psychiatric disorders: Delirium, insomnia, panic attack
Vascular disorders: Syncope
Read the entire FDA prescribing information for Marinol (Dronabinol Capsules)
Marinol, a medication that contains a compound similar to one found in marijuana, is FDA approved for chemotherapy-induced nausea and vomiting as well as anorexia from AIDS. But currently, there is no FDA-approved medical reason for prescribing marijuana itself. So, why is Marinol approved and not marijuana, and what are their differences? Here’s what you need to know.
What is Marinol?
Marinol is an FDA-approved medication with the active ingredient, dronabinol, a synthetic form of THC (delta-9-tetrahydrocannabinol) used to treat chemotherapy-induced nausea and vomiting treatment), as well as anorexia related to weight loss in patients with AIDS. THC is a natural component of the marijuana plant, Cannabis sativa, and it’s psychoactive, which means it attaches to chemical receptors in your brain and produces a feeling of euphoria, or what we call a “high.”
Both Marinol and generic dronabinol come in capsules of 2.5 mg, 5 mg, and 10 mg strengths. These medications take about 30 minutes to an hour to start working, with peak effects at 2 – 4 hours.
How much does Marinol cost?
Oral dronabinol is available as generic dronabinol with a cash price of about $250 for a typical prescription of sixty 2.5 mg capsules, as well as brand-name Marinol, which costs about three times more for the same prescription.
What’s the difference between Marinol and marijuana?
Marinol is approved by the FDA for medical uses, whereas marijuana has not been approved for any medical use at all at the federal level. Additionally, Marinol, or dronabinol, does not contain all the components of the full marijuana plant. The medication has a synthetic version of THC (delta-9-tetrahydrocannabinol), one of over 60 cannabinoids found in Cannabis sativa. Two cannabinoids in marijuana have been studied for medicinal uses: THC and cannabidiol.
Why do people use medical marijuana?
The use of medical marijuana for cancer pain is very controversial as it hasn’t been well studied. However, severe or chronic pain accounts for more than 90% of the qualifying conditions for use of medicinal marijuana among registered users in the states in which it is legal. While there have only been a few studies done, it appears that smoking marijuana along with traditional pain medications for patients with cancer-related pain may be effective.
Do Marinol and marijuana work for pain?
Marinol (dronabinol) has been studied for post-surgical pain, nerve-related pain, and chronic non-cancer pain. For the first two types of pain, Marinol was not found to be any better than placebo. For chronic non-cancer pain, it has been found to be only slightly better than placebo.
Marijuana has not been studied as much as cannabinoid pharmaceuticals, partly due to regulatory restrictions, but in the few studies that have been done, smoked marijuana was found to be better than placebo at relieving pain. A study that examined the effects of vaporized (not smoked) marijuana found that it too was better than placebo at relieving nerve-related pain.
What about for appetite and nausea?
Both marijuana and Marinol have been shown to help with nausea and loss of appetite in studies on HIV patients.
There are currently four FDA-approved cannabinoid medicines available in the U.S.: Marinol, Syndros, Cesamet, and Epidiolex. Nabiximols (Sativex), an oral spray with two cannabinoids (THC and CBD) is not yet approved by the FDA, but is endorsed by the American Academy of Neurology for treatment of spasticity (muscle rigidity) and nerve pain in patients with multiple sclerosis.
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Marijuana Pill May Be Better For Pain Relief
A pill form of marijuana provides greater pain relief than when a person smokes it, according to a new study.
The study was conducted by researchers at Columbia University in New York and was published in the journal Neuropsychopharmacology.
The pill, known as Dronabinol, contains the active ingredient of marijuana – tetrahydrocannabinol (THC) – and has already been approved to treat chemotherapy and AIDS patients with nausea and vomiting.
The scientists said:
“Recent studies have demonstrated the therapeutic potential of cannabinoids to treat pain, yet none have compared the analgesic effectiveness of smoked marijuana to orally administered tetrahydrocannabinol (THC; dronabinol).”
The study involved 30 participants (15 male and 15 female) who were marijuana smokers. The researchers, led by Ziva Cooper and Margaret Haney, set out to compare subjects’ daily pain response.
The volunteers were asked either to smoke marjuana, take oral Dronabinol, or a placebo. They then took part in an experiment called a “cold pressor test” where they immersed their hand into a bath of very cold water (4 degrees celsius) for up to two minutes.
How long it took them to report pain (pain sensitivity) and remove their hand from the water (pain tolerance) were documented.
Results showed that compared to placebo, marijuana and Dronabinol:
- lowered subjective ratings of pain
- reduced pain sensitivity
- increased pain tolerance
A past study found that for patients with chronic neuropathic pain, smoking cannabis reduced their symptoms of pain, improved their mood and helped them sleep.
However, the experts in the current study found that the drug Dronabinol provided a longer-lasting effect in pain sensitivity and was less susceptible to abuse-associated outcomes, compared to marijuana.
“The magnitude of peak change in pain sensitivity and tolerance did not differ between marijuana and dronabinol, although dronabinol produced analgesia that was of a longer duration.”
A previous study showed that an oral tablet of THC tended to make the experience of pain more bearable, instead of actually decreasing the intensity of the pain.
The authors pointed out that the report only observed people who had previously smoked marijuana on a daily basis. Therefore, Dronabinol’s effects on non-smokers are still not known.
Although more research is necessary, the findings show potential for medical uses of the THC pill.
Written by Sarah Glynn
The Comprehensive Guide to Marinol (Dronabinol) [What It’s Used for]
While the marijuana plant and its associated cannabinoids are federally illegal, synthesized cannabinoids seem to be perfectly okay according to the FDA. Marinol, also known as Dronabinol, is a synthetic form of THC, the intoxicating compound in weed known for providing the ‘high’ you experience.
Unlike cannabis, Marinol is legal and FDA-approved. It is primarily used to treat nausea and vomiting associated with chemotherapy, and weight loss associated with HIV/AIDS. Now that medical marijuana is legal in 33 states plus D.C., Marinol’s market share has fallen significantly.
In 2016, the Marinol market was worth $150 million. In 2021, it is expected to fall to just $52 million. Aside from increased cannabis legalization, other cannabinoid-based pharmaceutical drugs are taking over. Epidiolex, which uses synthesized CBD, is expected to be worth $1 billion per annum in 2021.
While Marinol is no longer the behemoth it once was, it is still worth looking into the drug since tens of thousands of people still use it. In this guide, we look at Marinol, its side effects, and compare it to marijuana.
A Brief History of Marinol
Marinol is a synthetic form of THC, but while it shares the same chemical formula as the THC in marijuana, the elements are arranged differently within the molecule. It consists of pure THC which is dissolved in sesame oil and comes in pill form. Rather than ingesting THC from the cannabis plant, patients who consume Marinol are taking THC that has been synthesized in a lab.
Tetrahydrocannabinol was isolated from the marijuana plant in 1964 by Yechiel Gaoni and Raphael Mechoulam. The herb suffered a major blow in 1970 when the Controlled Substances Act classified it as a Schedule I drug with no recognized medical value and a high potential for abuse. The Act was a hammer blow to any hopes of researching weed and its cannabinoids in the United States.
Public opinion remained heavily against cannabis in the 1970s, although in 1978, New Mexico made history by becoming the first American state to pass a law which recognized the medicinal value of marijuana. The die had been cast, and while the federal government refused to consider legalizing the plant, Big Pharma smelled an opportunity to make money.
Big Pharma smelled an opportunity to make money.
In 1980, the National Cancer Institute (NCI) started experimenting with a new drug called Marinol. The NCI tested the drug on cancer patients in San Francisco. What happened next arguably changed the course of medical marijuana’s history.
While NCI studies found that some patients responded well to Marinol, six states conducted studies of their own on marijuana. They discovered that patients found the THC in natural marijuana safer and more effective than the synthetic version yet incredibly, the government decided to proceed with Marinol.
In 1981, the United States Government sold the Marinol patent to Unimed, who in turn applied to the FDA for permission to market the new drug as an anti-nausea treatment. The FDA initially denied the request in November of the year 1984 because the clinical trial results were not promising. However, Unimed quickly changed matters and provided further data which prompted the FDA to give its approval in June 1985.
Big Pharma and Cannabinoids
As controlled substances, any cannabinoids developed for medical use must go through an array of public health regulatory controls administered by the DEA and FDA. While the former determines a drug’s schedule, the latter is involved in regulating human testing and the introduction of new drugs into the market.
Aside from having to jump through a litany of hoops, manufacturers must spend a fortune on the research and development of drugs that may not make it to market. A 2017 study by the Tufts Center for the Study of Drug Development found that the average cost of the R&D of 10 selected cancer drugs was around $648 million each! However, while the ten drugs cost well over $7 billion to produce in total, they had earned the manufacturers $67 billion!
It is clear why Big Pharma is so keen to bring new drugs to market, but if a company’s efforts fail, it could ruin it financially. As far as Big Pharma and cannabinoids are concerned, the Orphan Drug Act of 1983 is one piece of legislation that helps them in their quest to monetize cannabis.
The Orphan Drug Act of 1983 is one piece of legislation that helps Big Pharma in their quest to monetize cannabis.
According to the Act, manufacturers are given incentives to develop drugs to treat ‘orphan’ diseases; conditions that affect less than 200,000 people in the U.S. A major incentive in the Act is exclusive marketing protection for seven years. During this time, the FDA is not allowed to approve the same drug when treating the same condition.
Therefore, a manufacturer could claim to be creating a drug synthesized from marijuana that treats conditions such as multiple sclerosis, Huntington’s, and spinal cord injury. If you look through the medical marijuana programs of most states, you’ll find that a lot of the qualifying conditions could be classified as ‘Orphan.’ As it happens, Marinol was approved for the treatment of more common conditions.
In December 1992, the FDA approved Marinol for weight loss treatment in patients with AIDS, and in July 1999, Unimed was successful in petitioning the DEA to move Marinol’s classification from Schedule II to Schedule III to ensure greater availability. It was a significant move. Unimed estimated that the rescheduling of the drug would see a sales increase of up to 20%.
The reason for the boost is obvious. The scheduling of a drug impacts its level of market penetration. Even today, physicians remain more apprehensive about prescribing a Schedule II drug than they do a Schedule III. There is also the small matter of Schedule II prohibition of refills, quantity restrictions, and triplicate prescriptions.
What Is Marinol Used for?
A majority of patients use it to treat HIV symptoms or to deal with the vomiting and nausea associated with cancer chemotherapy, and perhaps 10% use it for varying reasons. The final group may consist primarily of Alzheimer’s patients, even though it isn’t promoted for this form of treatment. It is usually used as a last resort when other drugs have failed.
There are also several ‘non-approved’ uses for Marinol, including as a treatment for ALS, Dementia, fibromyalgia, multiple sclerosis, chronic pain, and sleep apnea.
The dosage depends on your condition. Here are the recommendations as per the FDA:
- 5mg orally twice a day if you are an adult with AIDS.
- A starting dosage of 5mg every 1-3 hours before the administration of chemotherapy. After chemotherapy, use 5mg every 2-4 hours. You will use 4-6 doses per day. Use the first dose on an empty stomach at least 30 minutes before eating.
Marinol is available in 2.5mg, 5mg, and 10mg pills. Although it can vary, the cost of the drug is $692 for 60 x 2.5mg capsules. These prices are for cash paying customers only and are NOT valid with your health insurance plan.
In 2016, the FDA approved Syndros, an oral solution form of dronabinol. It is used to treat the same conditions as Marinol and was manufactured by the same company, Insys Therapeutics. It had hoped to breathe new life into its drug, but its market share has not grown to the level the firm had hoped.
- It is legal in every state and is widely available in most pharmacies.
- It is a pure isomer of THC. If you believe marijuana contains harmful chemicals, you don’t have to worry about consuming them.
- While it is a synthesized version of THC, it won’t lead to an intoxicating high.
- It has a long half-life, which means it stays at a therapeutic level in your blood for twice as long as cannabis.
- As it isn’t smoked or otherwise inhaled, it is less likely to cause lung or throat irritation.
- A variety of health insurance plans cover it.
- As it is manufactured under controlled conditions, it is less likely to be tainted.
- It has a low absorption rate, which means 10mg of THC from Marinol is not as effective as 10mg of THC from marijuana in a therapeutic sense.
- It can be far more expensive than weed if your insurance doesn’t cover it.
- The studies outlining its efficacy are contradicted by research, which suggests it isn’t that effective.
- It has a lengthy list of side effects, including drowsiness, confusion, and dizziness. While it isn’t supposed to provide a psychoactive high, some patients report feeling one all the same. It can also cause vomiting and nausea!
It is important to go to a doctor immediately if you faint, experience a rapid increase in your heart rate or a significant change in your mental state after using Marinol.
Marinol was approved for use in 1985, even though there was a lack of concrete evidence that backed up the claims of its manufacturers. The fact that it is consumed orally massively hinders the performance of the drug because much of the THC is metabolized before reaching the bloodstream.
It took a long time for hard evidence to emerge. One of the first studies that somewhat legitimized dronabinol took place in 1995, a full decade after the drug’s approval! The study by Beal et al. was published in the Journal of Pain Symptom Management. It involved just 139 patients with AIDS-related anorexia.
Each patient received 2.5mg of dronabinol twice a day or a placebo. Efficacy was only evaluable in 88 of the volunteers! The researchers found that those who used the drug enjoyed an increase in appetite of 38% above the baseline, compared to 8% of those who used the placebo.
A larger study, by Tramer et al., published in the British Medical Journal, in 2001, looked at the effectiveness of cannabinoids in 1366 patients. The researchers used oral dronabinol, intramuscular levonantradol, and oral nabilone. They found that the cannabinoids were effective when treating the vomiting and nausea caused by chemotherapy.
A review of studies on THC, conducted by Grant et al. at the University of California Center for Medicinal Cannabis in 2012, analyzed findings of studies into Marinol. The researchers found that a 25mg dose of Marinol was better at achieving pain relief in patients with Multiple Sclerosis than a placebo. They also found that a 25mg dose was better at reducing chronic neuropathic pain than a placebo.
However, a 2016 study by May and Glode, published in Cancer Management and Research, concluded that there was “insufficient data to support the use of dronabinol as an antiemetic in all chemotherapeutic regimens.” They did, however, concede that it has some “beneficial effects.”
Is Marinol Better Than Marijuana?
Although usage of Marinol is on the wane in the United States (it was discontinued in Canada), it still has its proponents. It is crucial to note that while Marinol contains THC, it is nothing like the THC found naturally. Marinol does not contain the hundreds of compounds found in cannabis.
Why is this important? It is likely that the cannabinoids and terpenes found in marijuana reduce the negative effects associated with THC such as anxiety and dizziness. Certainly, CBD (cannabidiol) helps reduce the psychoactive high you get from THC.
In 2001, Lester Grinspoon, Professor of Psychiatry at Harvard Medical School, said he had yet to find a patient that found Marinol more useful than natural marijuana. He asserted that if marijuana were legal, few patients would choose Marinol.
In 1999, the Institute of Medicine said that Marinol isn’t effective because taking it orally slows the absorption rate and prevents patients from having control over dosing. In 2002, Andrew Weil from the University of Arizona’s School of Medicine condemned Marinol by saying it isn’t effective enough. He spoke to numerous patients, and all of them said the pill didn’t work as well as natural herb, and it resulted in even greater intoxication.
In 2002, Robert L DuPont, the President of the Institute for Behavior and Health, led the rebuttals by claiming that cannabis plants are “unstable mixtures of different chemicals” and should not be used for medical treatment. DuPont said that no plant should ever be allowed as a medicinal treatment because they can’t be used directly to provide a specific dosage of any one chemical. In contrast, Marinol provides a pre-measured dose of THC, which he believes is a much better option.
Marinol provides a pre-measured dose of THC, which may be a better option for many patients.
It was interesting to read that DuPont used the FDA’s approval of Marinol in 1985 as proof that it was a better option than natural marijuana. This is in spite of several state studies which clearly showed that patients not only preferred natural THC but claimed it was more effective.
In 2006, the Office of National Drug Control Policy (ONDCP) cited the 1970 Drug Abuse Prevention and Control Act, which classified marijuana as a Schedule I drug with no recognized medical value. The ONDCP described Marinol as a “safe and legal version of medical marijuana” and claimed that smoking marijuana was likely to harm your health.
When you look at Marinol closely and compare it with medical marijuana, it has the following drawbacks:
- It is very expensive, and if it isn’t covered by your insurance, you may not be able to purchase it.
- Marinol is believed to cause many more side effects than weed.
- It can take up to 90 minutes to feel the effects. In contrast, weed can provide relief in a matter of minutes.
- The dosages of Marinol are rigid. When you smoke a joint or vape cannabis oil, you can adjust your dose as needed.
- If Marinol is stored outside of a temperature range of 46 to 59 degrees Fahrenheit, it can break down.
- Hypersensitive reactions include rashes, hives, a burning sensation, throat tightness, and lip swelling.
- Overall, the level of relief you get is severely limited when compared to medical marijuana.
- The bioavailability of Marinol is extremely poor. No more than 20% of the synthesized THC reaches your bloodstream.
Final Thoughts on Marinol
Marinol’s success was primarily based on the limited availability of medical marijuana. When it was initially released, it had a decade long run before a single American state, California, legalized medicinal weed in 1996. While its market share remained high for a long time, it has severely dwindled in recent times. With two-thirds of states now allowing medical marijuana, patients don’t want to bother with Marinol.
A study by Hazekamp et al., published in the Journal of Psychoactive Drugs in 2013, asked 953 people to complete a survey and answer whether they preferred synthetic THC or ‘the real thing.’ Fewer than 2% of respondents said they preferred synthetic THC, which suggests that Marinol’s severe decline is down to greater availability of marijuana.
The fact of the matter is that an increasing number of studies are conclusively proving that medical marijuana is a vastly superior treatment to pharmaceutical drugs for dozens of conditions ranging from PTSD to chronic pain. Marinol’s impact is relatively limited, and it carries several side effects.
Also, it is extremely difficult for patients to self-adjust their dosage since Marinol comes in pill form and takes much longer to become effective than smoked marijuana. Many of the side effects associated with Marinol don’t occur in natural marijuana because its additional compounds counteract many of the negative effects of THC. Marinol will continue to sell well, but it is clear that patients prefer natural THC, just like they did in 1980.