Psycheceutical Bioscience, Inc. announced the publication of pre-clinical observational data that supports the potential of its NeuroDirect™ ketamine topical cream as a treatment for PTSD. The preliminary observational data indicates that the non-systemic topical cream could be more effective at treating PTSD symptoms than current ketamine treatment options, which utilize systemic delivery methods. Additionally, the study supports the Company's belief that the topical cream approach would be more cost-effective than current ketamine therapy options.

Observational data was collected in a non-clinical setting from an outpatient Neurology and Neuropsychiatry practice, examining 100 patients with intractable depression, anxiety, and other symptoms commonly associated with PTSD. Subjects were patients with long-term symptoms related to PTSD who had each tried numerous previous other treatments. The patient group was comprised of 61 females and 39 males, and the patients' ages ranged from 12 to 90 years.

Objective measures like the Hamilton Depression Scale and EEG tracings documented the patients' responses. Family members and other observers also noted additional benefits from the treatment. The innovative, non-systemic delivery method is being designed to deliver compounds across the blood-brain barrier while bypassing the GI tract and liver.

Patients indicated relief of PTSD symptoms within minutes after using NeuroDirect ketamine applied as a topical cream on the back of the neck. Eight patients had NeuroDirect ketamine applied during EEG recording. All exhibited EEG improvement 3-5 minutes after treatment.

Within 8-10 minutes of topical drug application, patients noted discernible improvement in anxiety, depression, paranoia and unrealistic fear, focusing issues, cloudy thinking, neuropathic pain, and other such symptoms. Six patients studied before and after treatment with ketamine exhibited a reduction in HAM-D scores of 40, 22, 13, 11, and 7 points 15 minutes after ketamine application. Psychogenic effects, such as hallucinations or dissociative phenomena, were not expressed as having been experienced by any patient–all patients reported feeling clear-headed, more focused, and more aware of their surroundings.