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Cluster Headache Help and Support >> Medications, Treatments, Therapies >> SUMATRIPTAN (Imitrex)=SKIN PATCH http://www.clusterheadaches.com/cgi-bin/yabb2/YaBB.pl?num=1267213903 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 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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