Intranasal Therapy for Major Depressive Disorder Gets Fast Track Status
The Food and Drug Administration (FDA) has granted Fast Track designation to PH10 for the treatment of major depressive disorder (MDD).
PH10 is an investigational pherine nasal spray designed to bind to peripheral chemosensory neurons in the nasal passages to regulate the olfactory-amygdala neural circuits. The designation is supported by data from 3 clinical studies, including a phase 2a study in patients with MDD who received a 6.4μg dose of PH10 intranasally twice daily for 8 weeks.
Results showed that treatment with PH10 significantly reduced depressive symptoms as early as 1 week based on the 17-item Hamilton Depression Scale (HAM-D-17) scores compared with placebo (P =.022). The intranasal spray was found to be well tolerated, with no serious adverse events reported.
“Nearly two-thirds of diagnosed and treated depression patients do not achieve remission with a first line therapy,” said Shawn Singh, Chief Executive Officer of Vistagen. “With 21 million adults in the US suffering at least 1 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.”
December 16, 2022
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