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FAIR LAWN, N.J., Sept. 20 /PRNewswire-FirstCall/ -- Vyteris Holdings (Nevada), Inc. (OTC Bulletin Board: VYHN) announced today data from a Phase I study demonstrating that the Company's Actyve(TM) transdermal drug technology can be used to provide controlled delivery of zolmitriptan in humans. Vyteris is developing a product aimed at potentially improving upon existing treatments for migraine headaches using a class of drugs known as triptans. The study compared zolmitriptan pharmacokinetics following transdermal iontophoretic delivery and oral administration. Zolmitriptan is the active ingredient in Zomig(TM), which is indicated for the acute treatment of migraine.
'The treatment of migraine requires rapid onset of effect,' stated Vince De Caprio, Ph.D., President and Chief Executive Officer of Vyteris. 'We believe that a significant opportunity may exist to improve the therapy for migraines by changing the method by which triptans are administered. We believe our Actyve(TM) technology's programmable capability may allow rapid initial delivery of these drugs into the bloodstream which may act fast in treating the headache, followed by a sustained, low-level maintenance dose, which may be able to prevent headache recurrence. We know of no other product in the market or under development with this dual capability.'
The Company's Actyve(TM) transdermal technology uses a small electric current to deliver drugs across the skin. The two-component system employs a transdermal patch containing the drug and a small battery-powered electronic controller that precisely controls the rate and amount of drug released from the patch.
In these studies, two electrical current profiles were used to control the transdermal delivery rate of zolmitriptan and were compared with orally administered Zomig(TM) (5 mg) tablets in fourteen fasted, healthy volunteers. The first current profile was designed to enable rapid entry of the drug into the blood stream followed by delivery of a lower sustained release of the drug.
The second current profile provided a bolus-like input three hours after commencing iontophoretic administration, to simulate an on-demand increase in the delivery rate. Blood plasma concentrations of zolmitriptan from the Actyve(TM) patches closely followed the applied current profile and at early time points were higher than those following oral administration. The iontophoretic treatments were well tolerated and any instances of skin irritation were mild and resolved quickly.
'This early Phase I clinical study shows that through proper control, it is possible to rapidly deliver the drug into the blood stream as well as provide sustained delivery over several hours,' stated Dr. David Friend, Vice President of Research for Vyteris. 'Although many more clinical studies need to be undertaken before FDA approval can be sought, the results of this first clinical study are encouraging. Because the drug level in the blood has been shown to closely follow the applied current, it may be possible to develop a product whereby the patient may benefit from the added control offered by this technology when compared with oral dosing of anti-migraine agents.'
About Migraines
According to the National Headache Foundation, migraine pain and associated symptoms affect 29.5 million Americans, equivalent to 13 percent of the population, and one in every four U.S. households has a migraine sufferer. Migraine is characterized by throbbing head pain, usually located on one side of the head, often accompanied by nausea and sensitivity to light and sound. The combination of disabling pain and associated symptoms often prevents sufferers from performing daily activities. Attacks can last anywhere from four to 72 hours and tend to occur in three phases: pre-headache, the headache itself, and post-headache. The pre-headache and post-headache phases can last for hours to days with symptoms such as muscle tenderness, fatigue and mood changes.
While there are no definite answers to the causes of migraine, healthcare professionals are gaining an understanding of what happens when a migraine attack is in progress. Current theory suggests that migraines are triggered from within the brain itself. Once an attack begins, the pain and other symptoms of migraine arise from an inflammatory process resulting from an interaction between the trigeminal nerve and blood vessels in the coverings of the brain. Additional information may be obtained from the National Headache Foundation at www.headaches.org.
According to a 2004 market research report by Datamonitor, the market for triptans in the United States is estimated to be in excess of $2 billion. Triptans, also known as 5-HT1B/1D receptor agonists, are structurally related to the neurotransmitter serotonin (or 5-hydroxytryptamine or 5-HT), and have been shown to be an effective treatment for acute migraine episodes. They have several potential mechanisms of action including cranial vasoconstriction and peripheral neuronal inhibition. Rapid-acting dosage forms are desirable in order to provide fast relief from migraine symptoms and prevent headache progression. Research also suggests that drugs taken earlier during an attack may be more effective in providing pain relief.
About Vyteris
Vyteris Holdings (Nevada), Inc. is a specialty pharmaceutical company organized to develop and manufacture pharmaceutical products based upon its advanced drug delivery technology. The Company's Actyve(TM) transdermal drug delivery (iontophoresis) technology delivers drugs comfortably through the skin using low-level electrical energy. This technology allows precise dosing, thus providing physicians and patients with control in the rate, dosage and pattern of delivery. The Company's LidoSite(TM) product provides dermal analgesia prior to venipuncture (IV catheter insertions, blood draws, etc.) and superficial dermatological procedures. LidoSite(TM) received marketing clearance from the U.S. Food and Drug Administration and is marketed by B. Braun Medical Inc. For more information visit www.vyteris.com.
Forward-Looking Statement
Statements in this press release other than historical statements constitute 'forward-looking statements'. Such forward-looking statements are subject to material risks and uncertainties which could cause the Company's forward-looking statements to be materially inaccurate. The Company has described such risks and uncertainties under the caption 'Risk Factors' in various filings made with the SEC.
LidoSite(TM) is a trademark of B. Braun Medical, Inc.
Actyve(TM) is a trademark of Vyteris Holdings (Nevada), Inc.
Zomig(TM) is a trademark of AstraZeneca PLC. This clinical study was funded and undertaken by Vyteris as part of their ongoing research and development programs. No business or commercial relationship exists between AstraZeneca and Vyteris.
SOURCE Vyteris Holdings (Nevada), Inc.
