Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June 4 approval goal date, advancing approval of the drug in the U.S.
PharmaTher said it is “hyper-focused” on the commercialization of Ketamine, according to a March 11 press release.
“I am very pleased with the new FDA approval goal date of June 4, 2025, for our Ketamine drug. We are focused on solving the shortage issue of Ketamine and becoming the leading supplier of Ketamine to fill the demand gap in the U.S. market,” Fabio Chianelli, PharmaTher chairman and CEO, said in the release.
Ketamine has been on the FDA’s drug shortage list since February 2018, and PharmaTher aims to fill a gap in the market.
While ketamine is becoming more commonly used in patients suffering from post-traumatic stress disorder, treatment-resistant depression and other mood disorders, several industry groups have warned against “casual” usage.
The American Society of Anesthesiologists issued new guidelines stressing that ketamine should only be prescribed and administered by trained healthcare professionals.
“There are some places in the country where people can get ketamine delivered to their homes, with directions that someone has to monitor you. Anesthesiologists have been using ketamine for decades,” Ronald Harter, MD, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus and past president of the ASA, told Becker’s. “I’ve been in anesthesia for over 30 years and it was a tried and true drug when I started. We have been using it for various sedative indications for years and so we have the greatest level of understanding of the potential risk and side effects of it.”