1. Do you ever have one of those days?

2. The Ultimate Migraine A rhetorical look at treatments, research trials, and why having one is such a headache

3. Overview Migraines – What are they? What are the symptoms? What causes them? Is there a cure? Treatments – Do they work? Are there side effects? How effective are they? Clinical Research Trials – Purpose(s); How do they work? Are they a treatment alternative? Non-Prescription Meds – Are they a valid treatment option? Plus, one company’s success at snowing the public for a bigger piece of the Kopfschmerzen pie.

4. What is a Migraine? Recurring headache, mild to severe Often one-sided, but not always Characterized by throbbing, pulsating sensations Usually last from four to 72 hours, though may last a number of days or weeks

5. Causes Blood vessels in the head constrict, then dilate Low neurotransmitter levels may be a factor Heredity Age

6. Types of Migraines Classic Common Hemiplegic Abdominal Transformed Chronic Probable

7. Symptoms Sensitivity to light Sensitivity to sound Nausea, with or w/o vomiting Scotomata (blind spots) Teichopsia (bright shimmering or wavy lines) Fortification spectra (zigzag pattern) Photopsia (flashing lights) Paresthesias Visual and/or auditory hallucination

8. Common Triggers Certain foods, including cheese, chocolate and processed meats Smoking and nicotine Caffeine Monosodium glutamate Aspartame Weather Allergies Bright lights incl. Sunlight Loud noises High altitudes

9. Other Headache Types Tension Sinus Acute Medication Overuse Hormone Cluster

10. Evolution of Medication 1899 Aspirin 1928 Ergots 1974 Antiemetics 1979 NSAIDs 1990s Triptans

11. Abortive Therapy Treatments Aspirin – painkiller Ergot(amine) – suppository Antiemetic – anti-nausea therapy NSAID – anti-inflammatory Triptan – serotonin receptor antagonist

12. Triptans Imitrex (sumatriptan succinate) Amerge (naratriptan hydrochloride) Zomig (zolmotriptan) Axert (almotriptan malate) Relpax (eletriptan hydrobromide) Maxalt (rizatriptan) Frova (frovatriptan)

13. Imitrex First introduced in 1991 Revolutionized migraine treatments Available three ways tablets injection nasal

14. Imitrex Tablets 25mg, 50mg, 100mg Mild, short-lived side effects No more than 200mg in 24 hrs.

15. Imitrex Nasal Spray 20mg Bad taste common No more than 40mg in 24 hrs.

16. Imitrex Injection 6mg. Injection site irritation common Mild side effects No more than two in 24 hrs.

17. Preventative Meds Calcium Channel Blockers Beta Blockers Vitamin B2 (riboflavin) Antidepressants Anticonvulsants ‘Dopamax’

18. Rescue Meds/Other Celebrex (celecoxib capsules) Vioxx Midrin (isometheptene mucatate, dichloralphenazone, acetaminophen) Stadol (butorphanol tartrate)

19. Clinical Research Trials Test new drugs and treatments Provide alternatives to standard treatments Ensured safety is sought by strict protocol Risks, therapeutic benefits involved Informed consent Phase I, II, III (IV) Patient progress carefully monitored

20. Clinical Research Trials, cont. Placebo Blind/masked trials, randomization Rescue Medication Costs Criteria, medical or otherwise Trial results

21. Non-Prescription Meds May provide temporary relief Shorter effects; more pills may be needed Some doctors this is an unsafe practice. Overmedication and rebound headaches may result.

22. Excedrin Migraine Active ingredients: Aspirin, acetaminophen, caffeine First non-prescription medication for migraines approved by the FDA Designed to treat ALL symptoms One of the least expensive meds Contains “same enhancing ingredient” as some prescription drugs

23. More on Excedrin Migraine Three studies conducted 1,250 evaluated After two hours, 59% reported pain diminished or gone. After six, 79% reported pain as mild or gone. Placebo patients: 33% saw pain diminish after two hours; 52% reported mild or no pain after six hours

24. The Problem? Bristol-Meyers Squibb already had an identical product on the market, one that already carried the Excedrin moniker and contained the same active ingredients.

25. Extra-Strength Excedrin Active ingredients: aspirin, acetaminophen, caffeine Same ingredients and amounts as Excedrin Migraine Indicated for temporary pain relief

26. Comparison? Is it really that difficult to figure out? (Well, maybe if you’re the FDA!) Vs.

27. Rhetoric Television Magazines Web Medical pamphlets

28. Summation No two migraines are the same Symptoms and triggers vary Variety of treatments available Non-prescriptions may worsen headaches Most marketing leans toward women

29. The End