VistaGen Therapeutics (NASDAQ:VTGN) has announced that the US Patent and Trademark Office (USPTO) has provided a notice of allowance for a patent to treat depression with PH10. As quoted in the press release: Counterpart foreign patents have already issued in Europe, Japan and several other countries. In a small exploratory Phase 2a clinical study, at … Continued
VistaGen Therapeutics (NASDAQ:VTGN) has announced that the US Patent and Trademark Office (USPTO) has provided a notice of allowance for a patent to treat depression with PH10.
As quoted in the press release:
Counterpart foreign patents have already issued in Europe, Japan and several other countries. In a small exploratory Phase 2a clinical study, at microgram doses, PH10 nasal spray was observed to have rapid-onset antidepressant effects, without systemic exposure, psychological side effects or safety concerns.
“Currently approved antidepressants are not sufficient for millions of patients who suffer with depression. For many with an inadequate response to current antidepressants, living with depression is not living. Unfortunately, there is no one-size-fits-all treatment solution, and inadequate response to current antidepressants is among the key reasons MDD remains one of the leading public health concerns in the U.S.,” said Shawn Singh, Chief Executive Officer. “With mechanisms of action that are fundamentally differentiated from current antidepressants, we believe both oral AV-101 and PH10 nasal spray have the potential to address the significant unmet medical need for new antidepressant agents with rapid-onset activity, convenient at-home administration, and an acceptable safety and tolerability profile.”
Singh continued, “Once issued, this patent will be a key component of our commercial protection strategy for PH10 in the U.S., in a manner similar to our issued U.S. patent for therapeutic uses to treat depression with AV-101, which will not expire until at least 2034.”
PH10 is a potential first-in-class, CNS neurosteroid nasal spray administered in microgram doses for MDD. PH10 nasal spray activates nasal chemosensory receptors that, in turn, engage GABA (gamma-aminobutyric acid) and CRH (corticotropin-releasing hormone) neurons in the limbic amygdala system. The activation of these neural circuits is believed to have the potential to lead to a rapid antidepressant effects without psychological side effects, systemic exposure or safety concerns often associated with current antidepressants. Based on positive results of a small exploratory Phase 2a study in MDD in which rapid-onset antidepressant effects were observed without psychological side effects or systemic exposure, VistaGen is preparing for planned Phase 2b clinical development of PH10 for MDD.