Why the Trigeminal Nerve

Cluster headache, migraine, post-traumatic headache, and trigeminal neuralgia present differently, but each is driven by the same underlying pathway: the trigeminal nerve’s role in transmitting and amplifying head and facial pain.

The upper-posterior nasal cavity — the nasal turbinates — provides direct access to this pathway. Medication delivered here can reach trigeminal nerve structures more directly than oral or systemic routes, providing pain relief as fast (or faster than) injectable systemic therapies without the needle pain and harsh side effects.

How OFX-001 Works

OFX-001 is a self-administered, intranasal treatment designed to interrupt an acute pain attack in as little as 15 minutes, without the delay or systemic side effects of oral or injectable therapies. It translates the SPG block procedure, used in specialty clinics to block activation of the trigeminovascular system, into a product patients can use themselves, at the first sign of an attack.

The Conditions We Target

Cluster Headache

Often called the “suicide headache” for its severity, cluster headache produces excruciating, recurring attacks of head and facial pain — among the most severe pain conditions known. Despite this severity, there are only two FDA-approved drug therapies for cluster, both of which are injectable and have significant cardiovascular warnings.

Migraine

Migraine affects 12-15% of the population, and despite a wide range of available therapies, many patients still don’t achieve adequate relief. A significant share report ongoing dissatisfaction with their current treatment — due to incomplete symptom control, delayed onset, or side effects — underscoring the continued need for better acute treatment options.

Post-Traumatic Headache

Headache following traumatic brain injury (TBI) is increasingly recognized as a distinct and often persistent condition, and our understanding of its underlying mechanisms continues to evolve. There are currently no therapies approved specifically for post-traumatic headache, leaving patients to be managed with off-label therapies.

Trigeminal Neuralgia

Trigeminal neuralgia causes recurrent, severe facial pain that can be profoundly disabling to daily life. Existing treatment options — including anticonvulsant medications and surgical or ablative procedures — carry a high rate of adverse effects and, in many cases, provide only partial or temporary relief.

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