A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine

This is an open-label, twelve-month safety study. There is a screening period followed by a
run-in period (14 to 21 days) to determine eligibility for treatment with study medication
based on daily eDiary data collection. Qualified subjects will receive study medication on
Day 1 for up to twelve months for the treatment of migraine headaches. Migraines will be
treated with a single dose, consisting of two patches, but subjects can treat multiple
migraine attacks throughout the 12 months. Using the eDiary to confirm they are experiencing
a qualified migraine, subjects will self-administer the patches and continue to respond to
questions in the eDiary for 48 hours post treatment administration.

Main Inclusion Criteria:

1. Women or men 18 to 75 years of age

2. Greater than 1 year history of episodic, migraine (with or without aura) with onset
prior to 50 years of age.

3. Migraine history during the prior 6 months must include:

1. at least 2 migraines per month

2. no more than 8 migraines per month

3. no more than 15 headache days per month

4. Women of child-bearing potential must not be pregnant, must agree to avoid pregnancy
and use an acceptable double-barrier method of birth control during the trial.

5. Willing and able to treat a minimum of 2 migraines per month with study medication and
consistently complete eDiary for up to 12 months.

Main Exclusion Criteria:

1. Contraindication to triptans

2. Use of SSRIs (drugs like Prozac®) or SNRIs (drugs like Effexor®) or anti-coagulants
(drugs like Coumadin®)

3. Known allergy or sensitivity to zolmitriptan or its derivatives or formulations

4. Known allergy or sensitivity to adhesives and/or titanium

5. Women who are pregnant, breast-feeding or plan a pregnancy during this study

6. Three or more of the following cardiovascular risk factors:

- Current tobacco use

- Hypertension or receiving anti-hypertensive medication for hypertension

- Hyperlipidemia or on prescribed anti-cholesterol treatment

- Family history of premature coronary artery disease

- Diabetes mellitus

7. History or current abuse or dependence on alcohol or drugs