May 1, 2017
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"The US Food and Drug Administration (FDA) is looking into the risk for serious burns and potential permanent scarring with the use of the sumatriptan iontophoretic transdermal patch (Zecuity, NuPathe Inc) for migraine, the agency said in"...



(sumatriptan) Iontophoretic Transdermal System


ZECUITY (sumatriptan iontophoretic transdermal system) is a disposable, single use system designed to deliver sumatriptan through the skin using iontophoresis. Iontophoresis is a non-invasive method of delivering a drug through the skin using a low electrical current. The ZECUITY electronics, powered by two coin cell lithium batteries, control the amount of current applied and the rate and amount of sumatriptan delivered.

Sumatriptan succinate, the active component of ZECUITY, is a selective 5-hydroxy-tryptamine receptor subtype 1 (5-HT1 ) agonist (triptan). Sumatriptan succinate is chemically designated as 3-[2- (dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and has the following structure:

ZECUITY® (sumatriptaniontophoretic transdermal system) Structural Formula Illustration

The empirical formula is C14H21N3O2S•C4H6O4 representing a molecular weight of 413.5.

Sumatriptan succinate is a white to off-white powder that is freely soluble in water. Each ZECUITY iontophoretic transdermal system contains 86 mg sumatriptan (base) as the succinate salt in an aqueous formulation. ZECUITY, upon activation, delivers 6.5 mg of sumatriptan through the skin over 4 hours [see DOSAGE AND ADMINISTRATION].

ZECUITY iontophoretic transdermal system is composed of an iontophoretic device and a drug reservoir card. The reservoir card contains 2 non-woven pads and 2 different gel formulations; one a sumatriptan succinate formulation and the other a sodium salt formulation. The sumatriptan succinate formulation and pad contains the following inactive ingredients: purified water, basic butylated methacrylate copolymer (polyamine), lauric acid, adipic acid, methylparaben and a non-woven viscose pad. The salt formulation and pad contains: purified water, hydroxypropylcellulose, sodium chloride, methylparaben and a non-woven viscose pad. ZECUITY is a non-sterile product.

The iontophoretic device consists of medical grade adhesive fabric and foam and a plastic dome that contains an activation button, batteries, and electronics (see Figure 2).

Figure 2: Iontophoretic Device

Iontophoretic Device - Illustration

The sumatriptan and salt pads are housed in individual reservoirs. Each reservoir is sealed by a foil strip that is removed prior to transfer of the pads to the iontophoretic device (see Figure 3). The iontophoretic device and foil reservoirs are co-packaged in a single unit pouch [see PATIENT INFORMATION].

Figure 3: Reservoir Card

Reservoir Card - Illustration

For ZECUITY to function, the pads must completely cover the electrodes [see PATIENT INFORMATION].

Last reviewed on RxList: 12/20/2016
This monograph has been modified to include the generic and brand name in many instances.

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