FDA News

FDA approves Syndros for cancer, AIDS indications

The FDA approved dronabinol oral solution for the treatment of patients with cancer who experience chemotherapy-induced nausea and vomiting, according to a press release from the agent’s manufacturer.

Dronabinol oral solution (Syndros, Insys Therapeutics) — an orally administered liquid formulation of cannabinoid dronabinol, a version of tetrahydrocannabinol — is indicated for patients who failed to respond adequately to conventional antiemetic treatments.

The FDA also approved use of the agent for the treatment of anorexia associated with weight loss in patients with AIDS.

This is the first FDA–approved dronabinol solution for oral use.

Its liquid formulation allows for dosage to be titrated to clinical effect and, once opened, it does not need to be refrigerated for 28 days, John N. Kapoor, PhD, Insys Therapeutics’ chairman, CEO and president, said in a press release.

“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.

Company officials noted dronabinol oral solution may cause cognitive and psychiatric effects, as well as impair physical and/or mental abilities. Patients with cardiac disorders may experience hypertension, hypotension, tachycardia or syncope, according to the press release.

Insys Therapeutics officials expect to launch dronabinol oral solution in the second half of this year.

The FDA approved dronabinol oral solution for the treatment of patients with cancer who experience chemotherapy-induced nausea and vomiting, according to a press release from the agent’s manufacturer.

Dronabinol oral solution (Syndros, Insys Therapeutics) — an orally administered liquid formulation of cannabinoid dronabinol, a version of tetrahydrocannabinol — is indicated for patients who failed to respond adequately to conventional antiemetic treatments.

The FDA also approved use of the agent for the treatment of anorexia associated with weight loss in patients with AIDS.

This is the first FDA–approved dronabinol solution for oral use.

Its liquid formulation allows for dosage to be titrated to clinical effect and, once opened, it does not need to be refrigerated for 28 days, John N. Kapoor, PhD, Insys Therapeutics’ chairman, CEO and president, said in a press release.

“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.

Company officials noted dronabinol oral solution may cause cognitive and psychiatric effects, as well as impair physical and/or mental abilities. Patients with cardiac disorders may experience hypertension, hypotension, tachycardia or syncope, according to the press release.

Insys Therapeutics officials expect to launch dronabinol oral solution in the second half of this year.