FDA approves cannabis-derived drug

July 8, 2016

For the first time, FDA approved dronabinol oral solution (Syndros, Insys Therapeutics), a liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol ("THC").

For the first time, FDA approved dronabinol oral solution (Syndros, Insys Therapeutics), a liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (THC). 

Syndros is approved to treat anorexia associated with weight loss in patients with AIDS, as well as nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. 

Insys’s new liquid version is expected to be faster-acting and easier for nauseous patients to handle than the current branded capsule (Marinol, AbbVie) and generic versions, on the market.

Related: Top 5 facts about cancer drug costs

Approximately 9,500 prescribers account for 70% of current dronabinol prescriptions. Insys expects to convert a large portion of the market to Syndros as well as expand the market through direct detailing to physicians, highlighting the improved product profile of Syndros after it launches in the second half of this year.

"We believe that Syndros will be an important new treatment option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with weight loss in AIDS,” said Insys Chairman, CEO and president, John N. Kapoor, PhD.  

However, Syndros is awaiting scheduling by the U.S. Drug Enforcement Administration (DEA), which could affect profitability of the drug. If the drug launches as Schedule II, it could make an estimated 20% to 25% less than the peak annual sales of $200 million to $300 million it could net as a Schedule III drug, according to FierceBiotech.

Related: Drop in opioid Rx, overdoses linked to pharmacy changes

Still, Syndros has beneficial clinical features such as allowing the dosage to be titrated to clinical effect. In addition, once Syndros has been opened, it does not need to be refrigerated for 28 days. “We believe that these product features, coupled with patient support services, will prove to be important differentiators for patients and prescribers and will be key drivers of a successful market launch and sustained growth,” Kapoor said.

Syndros may cause psychiatric and cognitive effects and impair mental and/or physical abilities. Patients with cardiac disorders may experience hypotension, hypertension, syncope, or tachycardia. Physicians should weigh the potential risk versus benefits before prescribing Syndros to patients with a history of seizures, including those requiring anti-epileptic medication or with other factors that lower the seizure threshold.  

Read more: Top 4 new prescription opioid abuse facts