Rapid Communication

RAPID COMMUNICATION

ABSTRACT

The effectiveness of Migranade Migraine Relief, an effervescent formulation of reduced glutathione (GSH) in the treatment of acute migraine headaches

Current prescriptive and over-the-counter medications for migraine headache have limited efficacy and cause undesirable side effects and are due in part to a general lack of understanding of the etiology of the disease. We hypothesized that migraine headaches are in part, a consequence of a deficit in neuronal intracellular reduced glutathione levels due to disruptions in the transport of cysteine via the EAAT transport system and that exogenously supplied GSH could restore the neuronal GSH by circumventing the EAAT transport system. To overcome the obstacle of low GSH bioavailability, we developed MIGRANADE Migraine Relief, a patent pending, orally delivered formulation containing GSH in a proprietary effervescing delivery system designed to transport directly GSH to the CNS via the trigeminal nerves (NATIONAL DRUG CODE 60916-002-02). We report the testing of the efficacy of this product at relieving acute migraine headaches in adults experiencing moderate to severe migraine headaches.

The study was a single-center, open-label pilot efficacy trial. The study population consisted of 50 patients who had been diagnosed for at least 1 year with episodic migraine with or without aura. Subjects were asked to treat a single migraine attack within 8    weeks of their initial participation. Subjects were provided with two tablets of MIGRANADE Migraine Relief (an effervescent migraine medication) and instructed to dissolve the tablets in 8 ounces of water and drink it at once within 2 hours of the onset of a moderate to severe migraine headache (a minimum of 7 on a pain scale of 1 – 10 with 10 being intolerable.

The results showed a significant improvement in migraine headache status in 100% of subjects (N=50). There was a complete abatement of pain in 36% of subjects within 20 minutes of using MIGRANADE Migraine Relief. The overall level of effectiveness of MIGRANADE Migraine Relief was 84.6 ± 16 % with a mean time to maximum relief at 12.6 ± 6 minutes (n = 50). These results demonstrate that MIGRANADE Migraine Relief is very effective as a treatment for migraine headache without the side effects seen with other medications. It is likely that the GSH supplied orally via the proprietary effervescing delivery system, enters the trigeminal nerve and crosses the blood brain barrier, thereby restoring neuronal intracellular levels of reduced glutathione relevant to the genesis and propagation of migraine headaches.

ResearchIVEL Group