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FDA Approves Syndros, First Liquid Form of Cannabinoid Dronabinol

August 9, 2017
The Schedule II substance is approved for the treatment of cachexia and nausea and vomiting in AIDS and cancer patients, with the potential as a pain management agent.

Interviews with Diana C. Graalum, PharmD, BCPS, Sharmilla Patil, MD, Asher Goldstein, MD, and Damon Raskin, MD

The US Food and Drug Administration (FDA) recently approved Syndros, the first liquid form of synthetic cannabinoid dronabinol on the market.

Available by prescription only, Syndros is manufactured by Insys Therapeutics, and is approved to treat patients with Acquired Immune Deficiency Syndrome (AIDS) who are experiencing anorexia and weight loss (cachexia), as well as for people with cancer who are undergoing chemotherapy and suffer from nausea and vomiting that has not responded to conventional antiemetic treatments.1

Structural model of tetrahydrocannabinol (THC) molecule. Syndros contains a synthetic form of THC.

A New Drug Application

For physicians and patients, it’s important to know that “Syndros is approved by the FDA under a ‘New Drug Application’ or NDA; there are no therapeutic equivalent generic products at this time,” explained Diana C. Graalum, PharmD, BCPS, the Clinical Pharmacy Manager of MedSavvy, an independent website that offers information and tools to help people understand and manage their prescription medications.

Marinol, an approved form of dronabinol that comes only in soft gel capsules, and Syndros are classified by the Drug Enforcement Agency as Schedule II controlled substances, which means they could have a high potential for abuse, noted Dr. Graalum. [Editor's note: Medical marijuana is still classified as a Schedule I substance.]

The liquid form of this medication “may provide a more flexible administration option as well as a more rapid absorption with lower intra-patient variability compared with the capsule formulation,” said Sharmilla Patil, MD, an Integrative Medicine and Ayurvedic Specialist. “Ayurveda, a Traditional Indian Medical System, utilizes cannabinoids in many medicinal formulas for many digestive maladies. The known clinical effect of a compounded liquid oral supplement with cannabinoids demonstrates profound therapeutic benefits. This approach to health builds on the mind-body connection and includes natural herbs, body therapies and yoga/meditation to help balance the body. Usually the liquid dose is based on body surface area,” she said. (The body surface area is determined by height, weight, age, and gender.)

“Liquid can also be absorbed better in our bodies rather than a pill,” added Dr. Patil, who is the CEO and Founder of GreenTech Laboratories, Inc., a BioPharma company investigating cannabinoid formulas that is based in California. She pointed out that one reason for the liquid advantage is because the body doesn’t need to break down the liquid to assimilate it, the way it would with a pill. This allows liquid extracts to take only one to four minutes to assimilate or begin to work, while capsules take 20 to 30 minutes to take effect.

“Further, the body uses 98% of our liquid extracts, while it only utilizes 39% to 53% of capsules or tablets. You have to watch your dosage so your patient doesn’t over medicate since they would be the one controlling dosage at home,” Dr. Patil added.

In fact, this can also be a concern. “There is always the risk that a patient may take more than the prescribed dose [with capsules and liquid], but the liquid form of the medication may be easier to abuse,” cautioned Asher Goldstein, MD, of Genesis Pain Centers in New York City.

A Growing Treatment Trend

The FDA’s approval of Syndros may be indicative of a growing movement toward accepting synthetic forms of marijuana to treat different health issues, according to Damon Raskin, MD, a California-based physician who specializes in addiction medicine. Dr. Raskin also serves as the Chief Medical Officer of Cliffside Malibu Treatment Center in Malibu, California, which is known for treating many well-known figures grappling with drug addictions. 

He pointed out that Syndros contains a synthetic form of tetrahydrocannabinol (THC), a psychoactive component in marijuana that affects the central nervous system to bring about health benefits, including enhancing appetite and possibly helping to manage pain. Yet despite the potential it holds for pain, Syndros is not currently approved as a pain treatment method.

"The results of [studies on similar compounds] have been mixed; cannabinoids may or may not be better than placebo for treating pain. There are two cannabinoids approved in the United States: Dronabinol and Nabilone. Both have been shown to be effective in nausea/vomiting. These products may prove useful as part of a regimen to treat chronic cancer pain in palliative or ‘comfort’ care,"Dr. Graalum said.2,3

“Syndros has also been used off label by physicians for the management of pain and spasms [in other words, they are prescribing it for a condition other than which it has been approved for], in addition to being an anti-emetic [which is an approved usage],” noted Dr. Patil.

Dr. Raskin pointed out that not enough studies have been done to advise physicians on proper dosing of Syndros for patients in pain. This means that more studies need to be completed in order to better understand the benefits and risks, and to determine dosing schedules for optimal effectively as a pain treatment.

The hope is that Syndros, or other similar drugs, will prove to be valuable alternatives to opioids for the management of chronic pain, Dr. Raskin said. “Taking a product like Syndros would also likely be safer for pain patients than using medical marijuana, since Syndros is manufactured in a safe and highly regulated environment, while the quality of products purchase through a medical marijuana dispensary can have poor quality control” because they are not regulated by the FDA and therefore, could have safety issues (such as the risk of contaminants), and may also be lackinguniform packing and dosages such as those set by the FDA.

Medical Marijuana Controversy

With Syndros well positioned to compete in the same space as medical marijuana, it is perhaps not surprising that its approval has sparked some controversy in pro-legalization circles. The tension is further fueled by the fact that Insys is reported to have made a large donation to efforts opposing legalization in Arizona, where Insys is headquartered. This fact has sparked outrage among pro-marijuana supporters since the manufacturer has a vested financial interest in the outcome.

But for Dr. Raskin, the issue is much broader. “We have such an epidemic of opioid abuse and death, and we have to find an alternative to pain control. Exactly where Syndros will fit into the scenario still remains to be seen, though. Only time will tell what the best options are for pain patients,” he said.

Dr. Patil has disclosed that she owns stock/shareholder of Greentech Laboratories Inc. Drs. Goldstein and Graalum have no financial information to disclose.

Last updated on: August 9, 2017
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