Headache. 2009 Jun;49(6):817-25.

Zelrix: a novel transdermal formulation of sumatriptan.
Pierce M, Marbury T, O'Neill C, Siegel S, Du W, Sebree T.

NuPathe-Research and Development, Conshohocken, PA 19428, USA.

OBJECTIVE: This study evaluated the pharmacokinetic and tolerability profiles of Zelrix (NuPathe Inc., Conshohocken, PA, USA), the novel formulation of sumatriptan (formerly known as NP101).  Sumatriptan is also available as a nasal spray and subcutaneous (s.c.) injection. Therefore, the need to develop improved methods for noninvasive parenteral delivery of triptans remains high. METHODS: This was a Phase I, single-center, open-label, crossover study that assessed the pharmacokinetic properties of a single dose of sumatriptan delivered using an iontophoretic transdermal patch in comparison with oral, injection, and nasal delivery. Subjects were healthy male and female volunteers who received each of 5 treatments: sumatriptan 100 mg oral tablets, sumatriptan 6 mg s.c., sumatriptan 20 mg nasal spray, Zelrix I (transdermal patch with 3 g of gel solution delivering 6 mg of sumatriptan transdermally), or Zelrix II (transdermal patch containing 2.6 g of gel solution delivering 6 mg of sumatriptan). RESULTS: The C(max) for Zelrix was reduced to 30% and 28% of the sumatriptan s.c. dose, thereby reducing the risk of triptan-like sensations associated with high peak plasma concentrations. Plasma concentrations for Zelrix I and Zelrix II were intermediate between those for oral and nasal sumatriptan doses tested.  The AUC(0-inf) was approximately 99% for the Zelrix I patch and 100% for the Zelrix II patch as compared with sumatriptan 6 mg s.c. dose. Both doses of sumatriptan transdermal patches were well tolerated. Skin reactions at the patch site were mild and erythema resolved in most subjects within 48-72 hours.

CONCLUSIONS: THE RESULTS FROM THIS STUDY SHOW THAT SUMATRIPTAN ADMINISTRATION USING A NOVEL IONTOPHORETIC TRANSDERMAL TECHNOLOGY DELIVERS PLASMA LEVELS WITHIN THE RANGE FOR NASAL SPRAY, TABLET, AND INJECTABLE SUMATRIPTAN. ZELRIX I AND II WERE WELL TOLERATED AND ADVERSE EVENTS WERE MILD AND TRANSIENT. TRANSDERMAL DELIVERY OF SUMATRIPTAN USING THE SMARTRELIEF IONTOPHORETIC TECHNOLOGY MAY PROVE BENEFICIAL FOR A LARGE SEGMENT OF THE MIGRAINE POPULATION BASED UPON FAST, CONSISTENT DELIVERY OF DRUG AND AVOIDANCE OF COMMON GASTROINTESTINAL DISTURBANCES ASSOCIATED WITH MIGRAINE.

PMID: 19438727 [PubMed]

[Technical data edited out.--BJ]

What's here is what there is!

This is the first report I've seen on this product and so would expect some clinical trial reports to appear in time.

The links suggest, to me, that this new process is still very much in the developmental stage. I don't have access to this kind of material. Looks like it may be several years before we can expect products at the pharmacy--but exciting potential! (Beyond the technology development lies much FDA-type clinical testing.)

The interesting development is the process of delivering the med----

"About SmartRelief
SmartRelief is a proprietary iontophoretic system combining modern electronics with state‐of‐the‐art formulation and pharmaceutics technology. Iontophoresis is a non‐invasive method for transporting a molecule through the skin by means of a mild electrical current. The electrical current carries the charged molecule from the patch across the skin. Once across, the drug is rapidly absorbed by the microvascular and distributed systemically."