FDA Approves Liquid Formulation of THC-Containing Drug for CINV

Syndros is a liquid version of Marinol soft gel capsules and contains THC, the primary active compound in cannabis (marijuana).
BY ANDREW J. ROTH
PUBLISHED: JULY 05, 2016
The U.S. Food and Drug Administration (FDA) approved Syndros (dronabinol oral solution) on Tuesday for the treatment of patients experiencing chemotherapy-induced nausea and vomiting (CINV) who have not responded to conventional antiemetic therapies. The agent is also indicated for treating anorexia associated with weight loss in patients with AIDS.

Insys Therapeutics, Inc., the pharmaceutical company developing the drug, announced in a press release that Syndros would be available “in the second half of 2016.”

Syndros is a liquid version of Marinol (dronabinol) soft gel capsules and contains tetrahydrocannabinol (THC), the primary active compound in cannabis (marijuana). Marinol is developed by AbbVie Inc.

“Syndros is the first and only FDA-approved dronabinol solution for oral use. It is a liquid that is easy to swallow and allows for the dosage to be titrated to clinical effect,” John N. Kapoor, chairman, CEO and president of Insys, said in a statement, adding that, “once Syndros has been opened, it does not need to be refrigerated for 28 days.”

Syndros’ approval was based on a phase 1 trial looking at the bioequivalence and pharmacokinetics of the drug compared with Marinol. In the study, over 50 healthy volunteers received both the new oral formulation and capsules in different sequences. The effects of food and fasting on both formulations were analyzed.

The two formulations were determined to be bioequivalent in several areas among patients receiving the agent after fasting overnight. Detectable plasma dronabinol levels were seen after 15 minutes in 100 percent of patients receiving the oral formulation compared with less than 25 percent of patients receiving the capsule formulation. Further, variability among patients was lower (13.5 percent) with the oral formulation compared with capsules (36.8 percent).

Among patients who had eaten, initial dronabinol absorption was also more rapid with the oral solution (9 minutes) compared with capsules (about two hours). After 30 minutes, 100 percent of individuals receiving the liquid formulation had detectable plasma dronabinol levels, compared with 15 percent of those receiving the capsule formulation.

These trial findings were reported at the recent annual meeting of the American Society of Clinical Oncology, with the researchers noting that the new oral solution, “may provide a more flexible administration option as well as a more rapid absorption and lower intra-patient variability compared with the capsule formulation.”

According to the company’s press release following Syndros’ approval, the agent “may cause psychiatric and cognitive effects and impair mental and/or physical abilities. Patients with cardiac disorders may experience hypotension, hypertension, syncope or tachycardia.”

Further, this safety information states that physicians should assess patients for risk of abuse or misuse in patients with a history of substance abuse or dependence.

Insys first submitted a New Drug Application (NDA) for Syndros in August 2014, but was rejected two months later for providing an inadequate plan to study the safety and efficacy of the agent in pediatric patients. In June 2015, the company submitted an NDA again, which was accepted by the FDA in August 2015. In late March 2016, the FDA announced that it had received new, non-clinical information from Insys and would extend its decision date three months, from April 1 to July 1, 2016.

Talk about this article with other patients, caregivers, and advocates in the General Discussions CURE discussion group.
x-button
Special Feature
Share Your Art
Related Articles
Immunotherapy Offers New Optimism for Patients With Merkel Cell Carcinoma
Although chemotherapy has been used to treat patients with Merkel cell carcinoma, immunotherapy agents show great promise, according to findings presented at the 2017 World Congress of Melanoma.
CAR T-Cell Therapy Yescarta Approved to Treat Non-Hodgkin Lymphoma
Yescarta was granted FDA approval for use in adults with relapsed or refractory non-Hodgkin lymphoma. This is only the second CAR T-cell therapy ever approved.
Chemo Brain Barb
Two-time cancer survivor shares the frustrations of struggling with chemo brain. And yes, it's real.
Related Videos
Preserving Eyebrows During Chemotherapy Treatment
Renata Marie Vestevich, founder and developer of Essential Eyebrow Solution (EES), discusses how this topical solution may be able to help patients keep their eyebrow hair while undergoing chemotherapy.
Beth Sandy on Managing Chemotherapy-Induced Nausea
Beth Sandy, C.R.N.P, a nurse practitioner at the Abramson Cancer Center, discusses managing chemotherapy-induced nausea.
Using Body Composition to Dose Cancer Treatment
Grant Williams, M.D., clinical instructor and research fellow at UNC Lineberger Cancer Center, discusses the potential of using body composition to better dose cancer treatments such as chemotherapy.  
x
//For side ad protocol