Vistagen’s PH80 nasal spray will be used to treat migraines, including those associated with traumatic brain injury. Credit: Hermes Rivera on Unsplash.

The European Patent Office (EPO) has issued an intention to grant a patent for Vistagen’s new PH80 nasal spray to treat migraine.

The patent’s claims also include treatment given at the onset of migraine symptoms as well as the treatment of migraines associated with traumatic brain injury.

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The patent will remain active until at least 2040.

PH80 is a first-in-class, rapid-onset nasal spray designed to be used in a similar way to a rescue asthma inhaler.

It offers patient-tailored, user-friendly, intranasal administration as required, up to multiple times a day.

PH80 has a potential rapid-onset mechanism of action (MOA) which is fundamentally differentiated from all existing approved treatments for migraine.

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The therapy’s MOA does not need systemic exposure or direct action on the neurons of the central nervous system (CNS) to create a therapeutic effect.

This is a significant potential treatment advantage over traditional pharmaceuticals, including existing migraine treatments.

The new nasal spray works by initiating neural impulses in the olfactory bulb that quickly affect the functioning of multiple structures in the brain connected to migraine pathology, including the amygdala and hypothalamus.

In March 2023, PH80 nasal spray received a patent from the US Patent and Trademark Office (USPTO) to treat migraine.

Vistagen stated that the PH80 development programme focuses on the acute treatment of migraine and also on the management of menopausal hot flushes.