VistaGen says regulators couldn’t sniff out the abuse potential of its nasal spray for social anxiety -biotech.vision

VistaGen says regulators couldn’t sniff out the abuse potential of its nasal spray for social anxiety

VistaGen says regulators couldn’t sniff out the abuse potential of its nasal spray for social anxiety -biotech.vision

VistaGen Therapeutics will launch its nasal spray for social anxiety after the FDA said it did not need further studies to test the drug’s abuse potential.

The wave of regulatory bodies that VistaGen reported Thursday is good news for biotechnology, which is promoting its PH94B nasal spray through two Phase 3 studies on social anxiety disorder (SAD). The FDA has informed VistaGen that the candidate’s clinical and non-clinical data show no potential for abuse and that biotechnology does not require further human studies to prove this in the future.

In an interview with Fierce Biotech, VistaGen CEO Shawn Singh called the FDA consent “a big deal” as the company hopes to create an alternative treatment for benzodiazepines.

“Especially in this area and especially with the history of drugs that take up most of the space in anxiety and depression, especially anxiety with benzos,” he said.

Spraying is currently underway in two trials, Palisade-1 and -2, where the effects of the drug will be challenged through public speaking. Key dates are scheduled for the third and fourth quarters of this year.

The company hopes to combine data from both studies with a long-term safety study when it seeks approval. The FDA filing would also include data from a dose-response study and a dose reduction study to further demonstrate safety; Singh estimated that, hopefully, the company could apply for approval by the end of 2023.

Biotechnology is also working to launch Palisade’s global trial with Chinese company AffaMed Therapeutics, which has been licensed with PH94B VistaGen in China, South Korea, and Southeast Asia. Last month, VistaGen said Chinese regulators gave it the green light to start the process. The company also plans to recruit patients in Mexico, Canada, and South Korea.

VistaGen first acquired the rights to PH94B from Perin in 2018 for more than $ 2 million in unregistered common stock. The spray became the foundation for the VistaGen pipeline and was developed for five additional neurological disorders, including PTSD and adaptation disorders. The company that focuses on the central nervous system is also testing a second nasal spray, PH10, to treat depression and suicidal thoughts.

Looking ahead, Singh noted that PH94B is not entirely out of the ordinary; The FDA reserves the right to lift liability for abuse even after approval. But Singh is optimistic that VistaGen will continue to support his argument that the spray is safe.

“That is why we are confident and confident because it is not based only on non-clinical data, it is based on both non-clinical and clinical data and, of course, the clinical signs are crucial,” he said.

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