FDA Gives Fast Track Designation for Basimglurant in Individuals with Trigeminal Neuralgia
The Food and Drug Administration (FDA) has granted Fast Track designation for basimglurant (NOE-101; Noema Pharma, Basel, Switzerland) to treat individuals with trigeminal neuralgia (TN).
"We are very pleased to receive Fast Track designation from the FDA, which is intended to bring promising medicines to patients sooner, and very much underlines the potential of basimglurant in pain management associated with TN," said George Garibaldi MD, president, head of R&D of Noema Pharma. "The designation means we will be working closely with the FDA's Division of Anesthesia, Addiction Medicine, and Pain Medicine, which regulates Investigational New Drug applications and marketing applications of drugs for the treatment of pain. We look forward to increasing our collaboration with regulators and receiving feedback on the next steps for our clinical program in TN."
The LibraTN trial (NCT05217628) was a 24-week, prospective, double-blind, randomized-withdrawal, placebo-controlled study that evaluated participants treated with basimglurant—a highly selective, potent, and cell-penetrant negative allosteric modulator of metabotropic glutamate receptor 5 (mGluR5) that has been safe and well-tolerated in participants.
"TN is a chronic condition that affects the trigeminal nerve carrying sensations from the face to the brain, which can cause excruciating pain in those who suffer from it," stated Dr. Raymond Sekula, professor of Neurological Surgery at the Columbia University Irving Medical Center and principal investigator of the LibraTN study. "Four to five of every 100,000 people in the US are affected by TN every year. The most common of the very limited treatment options available is an anticonvulsant first approved over 50 years ago and associated with several limitations. It is critical that new therapeutic options be developed for this condition. Basimglurant is an exciting new product candidate with potential to help people afflicted with TN."