Zecuity patch fda prescribing information, side effects. Sumatriptan transdermal advanced patient information. Transdermal patch of sumatriptan offers sustained relief. The us food and drug administration fda approved the patch in january 20 for the acute treatment of migraine in adults. Ask your doctor or pharmacist if you have any questions. The sumatriptan iontophoretic transdermal patch is called zecuity. Availability of zecuity sumatriptan iontophoretic transdermal system, first and only transdermal patch system for the acute treatment of migraine.
Food and drug administration fda is investigating the risk of serious burns and potential permanent scarring with the use of zecuity sumatriptan iontophoretic transdermal. Jan 22, 2020 sumatriptan succinate is a white to offwhite powder that is freely soluble in water. Sumatriptan iontophoretic transdermal system zecuity is antimigraine drug that is delivered through the skin or transdermally. It belongs to the group of medicines called triptans. A recent development in drug delivery systems includes delivery of medication via a skin patch. Transdermal delivery of sumatriptan for the treatment of. Zecuity sumatriptan iontophoretic patch medication junction. Zecuity contains the drug, sumatriptan, which has been previously. A phase i, singlecenter, openlabel, randomized singledose, two way crossover study to compare the pharmacokinetics of two np101 patch applications sumatriptan iontophoretic transdermal system with and without controlled heat. Sumatriptan transdermal route precautions mayo clinic. An iontophoretic transdermal system its skin patch formulation of sumatriptan for the acute treatment of migraine attacks was approved by the us food and drug administration in january 20. A sumatriptan iontophoretic transdermal system for the acute. After submitting your request, you will receive an activation email to the requested email address.
On june 10, 2016 teva pharmaceuticals sent a socalled dear doctor letter to health care providers about zecuity, its migraine drug patch. Zecuity migraine patch sumatriptan iontophoretic transdermal. Zecuity sumatriptan iontophoretic transdermal system, the first skin patch for the treatment of migraine in adults, has been approved by the. It is also available in oral, intranasal, and injectable formulations. Jan 20, 20 the fda has approved zecuity sumatriptan iontophoretic transdermal system for the treatment of acute migraine in adults with or without aura zecuity is a batterypowered skin patch that. The patch was withdrawn less than 10 months after its.
Zecuity is no longer on the market as a treatment for migraine. Phase iii studies with an iontophoretic transdermal patch zelrixzecuity started in july 2008. Since marketing of the zecuity patch began in september 2015, a large number of patients have reported they experienced burns or scars on the skin where the patch was worn. The amount of drug delivered was determined by iontophoretic current. Fda, teva pharmaceuticals announce sales suspension of. Us9427578b2 us14185,485 us201414185485a us9427578b2 us 9427578 b2 us9427578 b2 us 9427578b2 us 201414185485 a us201414185485 a us 201414185485a us 9427578 b2 us9427578 b2 us 9427578b2 authority us united states prior art keywords sumatriptan patch ma treatment subject prior art date 20080619 legal status the legal status is an assumption and is not a legal conclusion. Zecuity sumatriptan iontophoretic transdermal system is a disposable, single use system designed to deliver sumatriptan through the skin using iontophoresis. Sumatriptan is a headache medicine that narrows blood vessels around the brain. Food and drug administration fda has approved sumatriptan iontophoretic transdermal system zecuity, nupathe inc for acute treatment of adults who have migraine with or without aura. May 27, 2009 the zelrix i patch contained 3 grams g of sumatriptan gel loaded with 120 mg of sumatriptan succinate. Zecuity sumatriptan iontophoretic transdermal system is a prescription acute medication for treating migraine attacks. Transdermal patch an overview sciencedirect topics. The sumatriptan iontophoretic transdermal system zecuity hereafter referred to as sumatriptan tds is the first transdermal treatment for migraine to be approved by the us fda.
Iontophoretic transdermal delivery of sumatriptan a new delivery system is the sumatriptan iontophoretic transdermal patch zecuity, which is a singleuse transdermal patch containing 86 mg of sumatriptan that delivers 6. A sumatriptan patch zecuity for migraine the medical. The novel iontophoretic transdermal sumatriptan patch. Sumatriptan comes with a patient information leaflet.
Zecuity iontophoretic transdermal system is composed of an iontophoretic device and a drug reservoir card. The sumatriptan iontophoretic transdermal system tds zecuity, nupathe, malvern, pa, a novel approach to the acute treatment of migraine, circumvents the gastrointestinal tract by using lowlevel electrical energy to transport sumatriptan across the skin. Sumatriptan works in the brain to relieve the pain from migraine headaches. This sumatriptan transdermal system may be a good choice for migraineurs with severe nausea or vomiting, those with intolerable triptanrelated. The patient instructions for use for sumatriptan iontophoretic transdermal system are appended to the prescribing information. An iontophoretic transdermal system its skin patch formulation of sumatriptan for the acute treatment of migraine attacks was approved by the us food and. Zecuity is an iontophoretic transdermal system tds or a deviceassisted skin patch that uses a mild electrical current to deliver sumatriptan through your skin. It can relieve migraine headache pain and the nausea that sometimes comes. The reservoir card contains 2 nonwoven pads and 2 different gel formulations. The fda has approved a sumatriptan iontophoretic transdermal system zecuity teva for acute treatment of migraine in adults. Jun 03, 2016 the sumatriptan iontophoretic transdermal patch is called zecuity. Sumatriptan iontophoretic transdermal system for the acute.
Iontophoresis is a noninvasive method of delivering a drug through the skin using a low electrical current. Zecuity patch sumatriptan iontophoretic transdermal system. Upon activation of the patch and application of an electrical current, the positively charged drug moves away from the anode, through the patients skin, and into. Zecuity is a serotonin 5ht1b1d receptor agonist indicated for the acute treatment of migraine, with or without aura, in adults who have a clear migraine diagnosis. Authormapper searches journal articles and plots the location of the authors on a map. Safety problems with a transdermal patch for migraine. The iontophoretic transdermal system formulation of sumatriptan as. Zecuity sumatriptan is a transdermal system patch selective serotonin receptor agonist used to treat acute migraine with or without aura in adults. Sumatriptan transdermal skin patch is used to treat migraine headaches in adults. Zecuity sumatriptan iontophoretic is a prescription drug used to treat migraine headaches. Sumatriptan iontophoretic patch for migraine request pdf.
This transdermal system bypasses the gastrointestinal tract, as it uses low electrical current to move sumatriptan transdermally into the subcutaneous tissue. Sumatriptan succinate is a white to offwhite powder that is freely soluble in water. The sumatriptan iontophoretic transdermal system zecuity was a combination drug patch, manufactured by teva pharmaceuticals, designed. What drugs, substances, or supplements interact with zecuity. Earlier this month, the fda announced its investigation of the risk for serious burns and potential permanent scarring with the use of the zecuity sumatriptan iontophoretic transdermal system. Sep 11, 20 sumatriptan iontophoretic transdermal system. The device was brought to market in september 2015 by teva pharmaceuticals, which had acquired nupathe.
Sumatriptan iontophoretic transdermal system medicinenet. The singleuse, batterypowered patch offers relief of migrainerelated nausea mrn as well as migraine headache pain. Optumrx specializes in the delivery, clinical management and affordability of prescription medications and consumer health products. The sumatriptan iontophoretic transdermal system zecuity was a combination drug patch, manufactured by teva pharmaceuticals, designed to treat migraine attacks. In the same study that assessed different possible patch polymers, 14 the authors also investigated the application of iontophoretic technology to the mcazone patch and determined that based on the observed sumatriptan transdermal flux of 284. The zelrix i patch contained 3 grams g of sumatriptan gel loaded with 120 mg of sumatriptan succinate. Zecuity sumatriptan iontophoretic transdermal system or patch is a medication prescribed to treat acute migraines with or without auras in adults. Zecuity sumatriptan iontophoretic transdermal system product. Sumatriptan iontophoretic transdermal system neurology. The fda approved a singleuse, batterypowered, iontophoretic transdermal system to deliver sumatriptan for the acute treatment of adult migraine with or without aura.
Us9427578b2 pharmacokinetics of iontophoretic sumatriptan. Important safety information what important information should i know about zecuity. May 02, 2017 patients were advised to stop using the zecuity patch immediately. Autoinjectors with needles have been previously available in europe and north america for several years. Use only after a clear diagnosis of migraine has been established 1. More recently, a transdermal delivery system has been.
No more than two zecuity patches should be used in any 24hour period. Gastrointestinal symptoms, such as nausea and vomiting, occur almost universally at one time or another in patients during a migraine attack. Zecuity sumatriptan iontophoretic patch medication. It is a serotonin 5ht 1b1d receptor agonist that is used for the acute treatment of migraine headaches in adults. Oct 28, 2019 zecuity sumatriptan iontophoretic transdermal system. The device delivers a subcutaneous injection of 6 mg sumatriptan, without the use of a needle. A new transdermal formulation of sumatriptan has recently become available in the usa for acute treatment of migraine in adults. Zecuity is a serotonin 5ht1b1d receptor agonist triptan indicated for the acute treatment of migraine, with or without aura, in adults who have a clear migraine diagnosis. The zecuity sumatriptan iontophoretic transdermal system was marketed for acute treatment of migraine. Safety problems with a transdermal patch for migraine headache. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.
Oct 19, 2007 the primary objective was to compare the pharmacokinetics pk of np101 sumatriptan iontophoretic transdermal patch with the currently approved oral, subcutaneous injection and nasal spray formulations of imitrex in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection. Zecuity sumatriptan iontophoretic transdermal system zecuity sumatriptan iontophoretic transdermal system preparation zecuity is a singleuse transdermal system tds or patch. Zecuity patch fda prescribing information, side effects and. We note that your july 9, 20, submission to snda 202278s001 includes final printed labeling fpl for your package insert, patient package insert, and instructions for use. Zecuity sumatriptan iontophoretic transdermal system. Patients with access to a computer and an internet connection may download them from the products website. Teva previously nupathe has developed a sumatriptan transdermal patch for the treatment of migraine and migraine related nausea. Zecuity is a serotonin 5ht 1b1d receptor agonist triptanindicated for the acute treatment of migraine with or without aura in adults 1 limitations of use.
Phase i study to compare np101sumatriptan iontophoretic. Sumatriptan is a serotonin1 sumatriptan transdermal teva adisinsight. Sumatriptan transdermal route proper use mayo clinic. Sumatriptan iontophoretic transdermal system for acute. This medicine comes with a patient information leaflet. Cady, kathleen farmer, in headache and migraine biology and management, 2015. Sep 30, 2019 zecuity is an iontophoretic transdermal system tds or a deviceassisted skin patch that uses a mild electrical current to deliver sumatriptan through your skin. Transdermal patch of sumatriptan offers sustained relief of. Availability of zecuityr sumatriptan iontophoretic transdermal system, first and only transdermal patch system for the acute treatment of.
A second zecuity patch should be used no sooner than 2 hours after activation of first. To optin for investor email alerts, please enter your email address in the field below and select at least one alert option. Each zecuity iontophoretic transdermal system contains 86 mg sumatriptan base as the succinate salt in an aqueous formulation. A new delivery system is the sumatriptan iontophoretic transdermal patch zecuity, which is a singleuse transdermal patch containing 86 mg of sumatriptan that delivers 6. Find patient medical information for sumatriptan transdermal on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Philadelphiaan iontophoretic transdermal delivery of sumatriptan provided statistically significant improvement compared with placebo for rapid, consistent, and sustained relief of acute migraine headache, according to research presented at the 14th congress of the international headache society.
Sumatriptan transdermal iontophoretic patch np101zelrix. Pdf sumatriptan transdermal iontophoretic patch np101. Transdermal sumatriptan is delivered through a single. In clinical trials, sumatriptan tds has provided consistent drug delivery. Zecuity sumatriptan iontophoretic transdermal systemdescription. The patch was applied to the upper arm, alternating right and left sides. Fda investigating migraine patch skin reactions webmd. Nausea is a common symptom of migraine, and current treatment guidelines recommend non. Sumatriptan transdermal iontophoretic patch np101 zelrix. The iontophoretic transdermal system formulation of.
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