International experts cooperating with the FDA have confirmed the efficacy and safety of eskatemine in treatment of unipolar, treatment-resistant depression, which might become the first cutting edge therapy for patients since the last innovation introduced 35 years ago. Celon Pharma develops this substance in two indications and is currently conducting phase II clinical trials.
On the basis of findings of a clinical trial conducted by Johnsson&Johnsson and with a significant majority of votes, a panel of independent experts cooperating with the FDA recommended registration of an esketamine-based drug in the treatment of unipolar treatment-resistant depression. In addition to the possibility of obtaining a quick therapeutic effect, the experts also pointed out the chance of significantly increasing the availability of the therapy, previously used off label, for patients who do not have other therapeutic options.
Maciej Wieczorek, PhD: This is very good news and I must admit that we have been anticipating it. The esketamine we are developing is currently in phase II clinical trials. We are the second company in the world, after J&J, to develop esketamine to treat depression. Unlike our competitor, we have extended our trial by including bipolar depression. The route of administration we plan, which is different from that planned by the competition, is inhalation; according to available scientific data it allows for better deposition of the drug and may also translate into an even better therapeutic effect.