FDA says nasal spray for social anxiety disorder lacks abuse potential

The FDA announced that PH94B, VistaGen Therapeutics’ intranasal drug to treat acute social anxiety in adults, lacks the potential for abuse.

According to a press release from VistaGen, the FDA stated that both nonclinical and clinical data from the PALISADE phase 3 program found that receptor binding data do not show that PH94B has affinity for abuse-related sites, such as dopamine, opiate, and no additional nonclinical studies are required to evaluate the drug’s abuse potential.

“There are more than 25 million people in the U.S. suffering from social anxiety disorder, and many of them do not have adequate treatment options available,” Shawn Singh, VistaGen CEO, said in the release. “This clear and timely feedback from the FDA further emboldens our team and our steadfast efforts to advance PH94B on behalf of the millions of people struggling with SAD."

The FDA additionally ruled that conducting a human abuse potential study on PH94B is not necessary at present; the need to do so may be revisited upon completion of current and planned clinical trials, according to the VistaGen release.

Editor's note: This story was updated May 17, 2022, to indicate that this information was announced in a press release from VistaGen. Healio regrets the error.