By: Arya Mathew, PharmD Candidate c/o 2014
About twelve percent of the U.S. population suffers from migraines, affecting adult women three times more than adult men. Migraines are returning attacks of moderate to severe, throbbing or pulsing pain, usually on one side of the head. Along with the severe pain, migraine sufferers also experience photophobia, sonophobia, and nausea that can lead to vomiting.1 In short, migraines have the potential to seriously impact one’s quality of life.
ZecuityTM (sumatriptan iontophoretic transdermal system) is a new option on the market to treat migraine headaches. It incorporates a popular oral drug entity, sumatriptan (Imitrex™), used for migraine management, into a battery-operated patch, making it the first in its class.2 The transdermal system uses electrical currents to move 6.5mg of drug into the body over a four hour time period. There is a small computer chip that helps monitor and regulate the electrical charge to ensure the efficiency of dosing.2 ZecuityTM is about eight inches long and four inches wide, and can be wrapped around either the upper arm or thigh.
According to the package insert, ZecuityTM must be applied and activated within fifteen minutes of launching assembly. Once applied, the activation button must be pushed and a red light will turn on. When the red activation light turns off, the patch has stopped working and can be safely removed. The patch should remain in place and stay dry for the full four hours or until the red activation light turns off. If the migraine still has not resolved, a second patch may be applied to a different site, no sooner than two hours after the termination of the first patch. Only two patches may be used within a 24-hour period.4
Sumatriptan iontophoretic (ZecuityTM) is contraindicated in patients who have a history of heart disease or stroke, peripheral vascular disease, coronary artery disease, transient ischemic attack, uncontrolled blood pressure, basilar migraines, ischemic bowl disease, Wolff-Parkinson-White syndrome or other disturbances of heart rhythm. The patch should not be used within 24 hours of another 5-HT1 agonist, such as another “triptan,” or an ergotamine-containing medication. Hypersensitivity to components of the patch, severe hepatic impairment, allergic contact dermatitis, or use of a monoamine oxidase-A inhibitor (MAOI) two weeks prior to starting therapy with ZecuityTM are contraindicated when using the patch. Concomitant use of sumatriptan iontophoreticwith selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), or MAOIs increase the risk of developing serotonin syndrome.4
The most common adverse effects associated with sumatriptan iontophoretic (ZecuityTM) are application-site pain, paresthesia, pruritus, warmth, discomfort, and erythema after removal of the patch. In two long-term, open-label studies, 99 out of the 662 participants withdrew from the study due to an adverse drug reaction (ADR), which were most commonly contact dermatitis and application-site pain. Some serious side effects of ZecuityTM include heart attack, stroke, arrhythmias, angina, allergic contact dermatitis, anaphylactic reactions, and serotonin syndrome. There is also the likelihood of developing medication overuse headaches from using sumatriptan iontophoretic (ZecuityTM)too often. It has not been tested in children and is Pregnancy Category C.4
ZecuityTM is an innovative delivery system of a well-established migraine medication. It can better serve those who are afflicted with migraines but cannot swallow medication or keep it down due to vomiting. Some drawbacks to the patch are time required for assembly, duration of therapy, application site reactions, and the social inconvenience wearing a large patch. Nonetheless, this new patch may be the treatment of choice for patients who are looking for new way to manage the debilitating pain of migraines.
- Migraine. National Institute of Health Website. http://www.nlm.nih.gov/medlineplus/migraine.html. Updated July 01, 2013. Accessed September, 8 2013.
- NuPathe’s Zecuity Approved by the FDA for the Acute Treatment of Migraine. NuPathe Website. \ir.nupathe.com/press-releases/nupathe-s-zecuity-approved-by-the-fda-for-the-acut-nasdaq-path-975802. Accessed September, 8 2013.
- Putting a Patch on Migraines. FDA Consumer Health Information. U.S. Food and Drug Administration Website. http://www.fda.gov/forconsumers/consumerupdates/ucm343935.htm?source=govdeliver.Updated April 12, 2013. Accessed September, 8 2013.
- Zecuity (TM) [package insert]. Conshohocken, PA: NuPathe Inc; 2013.