FDA Roundup: Cannabidiol Approved as the First Marijuana-Derived, Purified Drug Substance

Hi, I’m Jenna Payesko, and welcome to MD Magazine’s weekly FDA Roundup. Here’s your top FDA headlines from this past week.

This week the FDA approved Epidiolex oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, 2 rare and severe forms of epilepsy, for patients 2 years of age and older. This is the first drug FDA-approved to contain a marijuana-derived, purified drug substance. The FDA statement highlights that the cannabidiol does not cause intoxication or the euphoria associated with THC.

Similarly, the FDA approved Zemdri for treatment of certain multi-resistant complicated urinary tract infections. It’s to be administered once daily via an intravenous infusion and is indicated for patients 18 years of age and older who have limited or no alternative treatment options.

Genentech’s new drug application was accepted and granted priority review by the FDA for baloxavir marboxil, as a single-dose, oral treatment for acute, uncomplicated influenza in patients 12 years of age and older. The single-dose investigational oral medicine with a novel proposed mechanism of action is designed to target the flu virus in oseltamivir-resistant strains and avian strains. The FDA is expected to make a decision by Dec. 24 on approval.

The FDA granted a de novo application to market the CURVE Positive Airway Pressure delivery system for the treatment of obstructive sleep apnea. The system is designed to operate with less airflow, alleviating some of the complaints that arise with traditional CPAP systems.

The iStent inject Trabecular Micro-Bypass System was granted premarket approval by the FDA, which is indicated for the reduction of intraocular pressure in adult mild-to-moderate primary open-angle glaucoma patients undergoing concomitant cataract surgery. The device is expected to launch commercially in the third quarter.

Lastly, Pain Therapeutics reported that the FDA advisory committee voted 14 to 3 against the approval of REMOXY ER for the management of pain severe enough to require daily, long-term opioid treatment for which alternative treatment options are insufficient. The drug was specifically developed to deter oxycodone abuse, providing 12 hours of pain relief. If approved, REMOXY ER will be classified as a schedule 2 drug and would be subject to strict prescribing and dispensing rules. The PDUFA date is set for Aug. 7.

For these stories and more, visit us at MDMag.com. This has been Jenna Payesko with your FDA Roundup, thank you for watching.