Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Vyteris Holdings' Actyve transdermal technology has demonstrated in a phase I clinical trial that it can control the delivery of the migraine drug zolmitriptan. The company hopes that a controlled delivery will enhance the efficacy of the drug.
Subscribe to our email newsletter
The technology allows for zolmitriptan to be initially administered quickly in order to produce fast-acting pain relief for the migraine sufferer, followed by a slow release of the drug to provide sustained pain relief.
Zolmitriptan is the active ingredient in AstraZeneca’s Zomig, which is indicated for the acute treatment of migraine in adults.
In the phase I study, two electrical current profiles were used to control the transdermal delivery rate of zolmitriptan and were compared with orally-administered Zomig (5mg) tablets in 14 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 patches closely followed the applied current profile and at early timepoints 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.”
The company’s Actyve 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.