Dronabinol Oral Solution Approved for CINV

The U.S. Food and Drug Administration (FDA) has approved dronabinol oral solution (Syndros), an orally-administered liquid formulation of dronabinol, for the treatment of chemotherapy-induced nausea and vomiting for patients who fail to respond adequately to standard antiemetic therapies.¹

“Syndros is the first and only FDA approved dronabinol solution for oral use,” said Insys Therapeutics Chairman, CEO and President, John N. Kapoor, PhD in a press release. “It is a liquid that is easy-to-swallow and allows for the dosage to be titrated to clinical effect.”

Dronabinol oral solution may cause psychiatric and cognitive effect and impair mental and/or physical abilities. Patients with a prior history of cardiac disorders may experience hypertension, hypotension, syncope or tachycardia.

The risk for abuse or misuse should be assessed for patients with a history of substance abuse or dependence prior to prescribing dronabinol oral solution.

The most common adverse reactions are dizziness, euphoria, paranoid reaction, somnolence, thinking abnormally, abdominal pain, nausea, and vomiting.

The recommended starting dose and schedule is 4.2 mg/m² given to the patient 1 to 3 hours prior to the start of chemotherapy, then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses per day.                

Reference

1. Insys Therapeutics announces FDA approval of Syndros. Insys Therapeutics website [press release]. http://investors.insysrx.com/phoenix.zhtml?c=115949&p=irol-newsArticle&ID=2181815. Updated July 5, 2016. Accessed September 1, 2016.