VistaGen Therapeutics has announced that it is proposing a Phase 2a study of its PH94B aloradine nasal spray for the treatment of patients with adjustment disorder with anxiety caused by the COVID-19 pandemic, subject to approval by the FDA. The company said that it submitted the proposal through the FDA’s Coronavirus Treatment Acceleration Program (CTAP).
PH94B is entering Phase 3 development for social anxiety disorder and received Fast Track designation for that indication in December 2019. VistaGen licensed the nasal spray from Pherin Pharmaceuticals in 2018.
VistaGen CEO Shawn Singh commented, “The recent onset of mental health stressors associated with the COVID-19 pandemic is unprecedented and has affected nearly every person around the world. We strongly believe in PH94B’s potential as a first-in-class, rapid-onset anti-anxiety drug, without systemic exposure or safety concerns of current anti-anxiety drugs. With successful Phase 2 development of PH94B for social anxiety disorder completed and preparations for Phase 3 development underway, we now look forward to Phase 2 development of PH94B for adjustment order [sic], with the goal of achieving similarly positive treatment outcomes for individuals struggling to cope with difficulties related to COVID-19, as well as a wide range of other anxiety-provoking mental health stressors.”
Read the VistaGen press release.
