The FDA has awarded Fast Track designation to Vistagen’s PH10 pherin nasal spray for the treatment of major depressive disorder, the company said. Vistagen recently announced its plans for a Phase 1 trial of a re-formulated version of PH10 expected to begin in early 2023 after receiving a “Study May Proceed” letter from the agency.
Vistagen CEO Shawn Singh said, “Vistagen is laser focused on bringing an innovative treatment option to individuals suffering with debilitating depression. The FDA’s grant of the Fast Track designation for the development of PH10 in major depressive disorder is a significant regulatory milestone, aligned with our belief in PH10’s potential to improve the standard of care in a significant market where new and differentiated treatments are urgently needed. Nearly two-thirds of diagnosed and treated depression patients do not achieve remission with a first line therapy. With 21 million adults in the US suffering at least one major depressive episode in the past year, potentially millions of individuals are not getting the help they need. We look forward to working with the FDA’s Fast Track program as we advance development of PH10 in the United States.”
Read the Vistagen press release.
