CGRP

• A recent market research study (n=150) of Neurologists, Headache Specialists and Primary Care Physicians revealed that 93% of clinicians treating migraine have moderate to extremely high unmet needs for alternatives to triptan therapy.2 Clinicians stated their desire for fast and safe alternatives for two large pools of acute migraine patients – those who have an insufficient response to triptan therapy, and those who have contraindications to triptan use.
• ELYXYB’s product profile mapped with a high degree of certainty to these stated unmet needs.
• In clinical studies, patients treated with ELYXYB® demonstrated pain relief in as little as 15 minutes, and significant pain relief compared to placebo within 45 minutes in nearly 50% of patients.
• Approximately 34% of patients were pain free at two hours.3 Notably, these data are well differentiated from two other new oral migraine medications of a different class, calcitonin gene-related peptide (CGRP) receptor antagonists.

• A total of 88 patients were enrolled in this multi-site study in the U.S. Topline results are expected in early December 2023.
• Tonix believes that by engaging and activating oxytocin receptors in the trigeminal ganglia, TNX-1900 has the potential to help those suffering from chronic migraine.
• “TNX-1900 is being developed as a novel, non-CGRP antagonist approach to treatment for chronic migraineurs,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
• “We would like to thank the participants, their families, and all the investigators and researchers who have been an important part of this journey so far.”

• Now with the July commercial availability of Zavzpret, Spherix has begun tracking its launch in the Launch Dynamix™: Zavzpret for Acute Treatment of Migraine study.
• As of June, over three-quarters of physicians planned to prescribe Zavzpret to their migraine patients within the first six months of availability.
• One way to tease apart the relative advantages and disadvantages of new migraine therapies is to utilize Spherix’s Launch Dynamix™: Zavzpret series.
• Spherix will be tracking the awareness and perception of these investigational, pipeline therapies in its separate service, RealTime Dynamix™.

• However, even in Canada, with a universal health-care system, migraine is underdiagnosed and undertreated.
• Policymakers need to act now to remove the barriers to accessing migraine medications in Canada, particularly as new medications are marketed.

What is migraine?

• Pain typically affects one side of the head and presents with nausea or vomiting, sensitivity to light or sound and interference with routine physical activity.
• Migraine can be episodic (fewer than 15 headache days per month) or chronic (15 or more headache days per month for longer than three months).

Impact of migraine

• Migraine is associated with lost productivity and with other health conditions including asthma, epilepsy and cardiovascular disease.
• Furthermore, migraine can contribute to mental health problems, including depression and anxiety.
• Canada is no stranger to this trend, where migraine affects 4.7 per cent of men and 11.8 per cent of women each year.

Historically, migraine has been underdiagnosed

• Factors influencing diagnosis include an individual’s ability and willingness to access care, and a physician identifying and correctly diagnosing migraine.
• However, research has demonstrated that for chronic migraine, most individuals report consulting a physician about their headaches.
• This suggests that in people with chronic migraine specifically, underdiagnosis may be driven by the failure to receive a correct diagnosis from a health-care provider.

Migraine-specific medications are under-used

• Triptans are among the oldest migraine-specific medications, and the first-line treatment for migraine for those who do not get relief from over-the-counter medications.
• Despite this, many individuals living with migraine in Canada do not use or have not tried migraine-specific medications.
• As new migraine-specific medications are approved in Canada, it is important that those who need them can access these treatments.
• These medications are used to prevent migrainous headaches, and cost over $600 per month.

Steps you can take if you think you might have migraine

• Migraine Buddy is a migraine tracking app with a questionnaire to help individuals determine if they may have migraine and should discuss their symptoms with a physician.
• Effective treatment options exist to manage migraine, which can be accessed through a physician.