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Cluster Headache Help and Support >> Medications,  Treatments,  Therapies >> SUMATRIPTAN (Imitrex)=SKIN PATCH
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Message started by Bob_Johnson on Feb 26th, 2010 at 2:51pm

Title: SUMATRIPTAN (Imitrex)=SKIN PATCH
Post by Bob_Johnson on Feb 26th, 2010 at 2:51pm
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]

Title: Re: SUMATRIPTAN (Imitrex)=SKIN PATCH
Post by DennisM1045 on Mar 9th, 2010 at 10:32am
Good info Bob.   Thanks for posting this.

Was there anything about onset of action times?

-Dennis-

Title: Re: SUMATRIPTAN (Imitrex)=SKIN PATCH
Post by Bob_Johnson on Mar 9th, 2010 at 12:24pm
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.

Title: Re: SUMATRIPTAN (Imitrex)=SKIN PATCH
Post by MJ on Mar 9th, 2010 at 10:55pm
Bob initial trials began last year with the Zelrix patch.

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"Pain relief within one hour: 29 percent of (migraine) patients treated with Zelrix" 

With the transdermal iontophoresis methods some other drugs are being delivered as fast as 10 minutes = to a imi shot and the patch abrasion methods in as little as 10 seconds.

It would seem as the technology of powered patches improves and has improved the speed of delivery will improve. Hit a switch at the thought of CH and its gone allmost.. Power up and power down. adjust dosages for time durations and leave on or schedule for the impending hit at 8:45 maybe.

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NuPathe planned to present a comprehensive summary of the data from this trial at the past 14th Congress of the International Headache Society held in Philadelphia, PA from September 10-13, 2009.
Unable to locate that though. Bob J maybe you can find or have access to that one.
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Title: Re: SUMATRIPTAN (Imitrex)=SKIN PATCH
Post by Bob_Johnson on Mar 11th, 2010 at 3:59am
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."

Title: Re: SUMATRIPTAN (Imitrex)=SKIN PATCH
Post by Bob_Johnson on Mar 15th, 2010 at 3:18pm
Today, someone from Canada posted (and now I can't find it) saying that they had been given this patch.

So, maybe the FDA will be acting soon for the U.S. !

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