Teva Announces U.S. Availability of ZECUITY® (sumatriptan iontophoretic transdermal system), First and Only Transdermal Patch System for the Acute Treatment of Migraine

Loading...
Loading...
Teva Pharmaceutical Industries Ltd.
TEVA
today announced that ZECUITY®, the first and only patch system designed to provide relief from migraine, is now available by prescription through specialty pharmacies. ZECUITY® is a single-use, disposable patch system that delivers sumatriptan through the skin. The device is designed to be worn for a four-hour period either on the upper arm or thigh. Approximately 36 million people in the United States suffer from migraine and its various characteristics. According to the American Migraine Study II, 85 percent of respondents experience throbbing pain, 80 percent experience sensitivity to light, 76 percent experience sensitivity to sound and 73 percent experience nausea. "Migraine sufferers experiencing nausea as part of their migraine may delay or avoid treatment and may seek non-oral treatment options," said Dr. Michael Hayden, President, Global R&D and Chief Scientific Officer. "At Teva, we are committed to delivering innovative treatments that improve patient care and are proud to offer ZECUITY® to people looking for a different route to migraine relief." In a clinical study, at two hours following application, significantly more patients using ZECUITY® versus a non-medicated patch system reported, as the study's primary endpoint, no headache pain (18 percent versus 9 percent). The secondary endpoints of the study showed that, at two hours following application, significantly more patients reported no nausea (84 percent versus 63 percent), no sensitivity to sound (55 percent versus 39 percent), no sensitivity to light (51 percent versus 36 percent), or headache pain relief (53 percent versus 29 percent). The most common side effects reported for ZECUITY® included pain, tingling, itching, warmth, discomfort or a change in the skin color at the application site of ZECUITY®. In conjunction with the availability of ZECUITY®, Teva is launching Migraine Support SolutionsSM to provide migraine education and assistance with ZECUITY® including a special offer that could save patients money on their prescriptions. To contact Migraine Support SolutionsSM, call 1-855-ZECUITY (1-855-932-8489). ZECUITY® is a prescription medicine used for the acute treatment of migraine headaches with or without aura in adults. ZECUITY® is used for people who have been told by a healthcare provider that they have migraine headaches. ZECUITY® is not used to prevent or decrease the number of migraine headaches you have. Important Safety Information ZECUITY® can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop using ZECUITY® and get emergency medical help right away if you have symptoms of a heart attack. ZECUITY® is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. Do not use ZECUITY® if you have: heart problems or a history of heart problems; had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation; narrowing of blood vessels to your legs, arms, stomach, or kidney; uncontrolled high blood pressure hemiplegic migraines or basilar migraines; taken any triptan, ergot, or ergot-type medicines in the last 24 hours. Ask your doctor if you are not sure. severe liver problems; or an allergy to sumatriptan, the medicine in ZECUITY®, or any of the components in ZECUITY®. ZECUITY® may cause other serious side effects including: injury during a Magnetic Resonance Imaging (MRI). ZECUITY® contains metal parts and must be removed before an MRI. allergic contact dermatitis—a serious skin reaction where ZECUITY® is applied. changes in color or sensation in your fingers and toes stomach and intestinal problems problems with blood circulation to your legs and feet medication overuse headaches serotonin syndrome—a rare but serious problem that can happen in people using ZECUITY®, especially when used with anti-depressant medicines called SSRIs or SNRIs. increases in blood pressure serious allergic reactions. Get medical help right away if you have any of these symptoms: swelling of your face, lips, mouth, or tongue; trouble breathing; wheezing; severe itching; skin rash, redness, or swelling; dizziness or fainting; fast heartbeat or pounding in your chest; or sweating. seizures. The most common side effects of ZECUITY® include pain, tingling, itching, warmth, discomfort or a change in the skin color at the application site of ZECUITY®. For full Prescribing Information, please visit ZECUITY.com/PDF/ZECUITY_PI.pdf For more information, visit www.ZECUITY.com or call 855-ZECUITY (855-932-8489)
Loading...
Loading...
Posted In: NewsFDAPress Releases
We simplify the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...