Search this Site
News
Ivrea Pharmaceuticals Announces Successful In Vitro Nail Penetration Results with IVR 101 and IVR 102
Ivrea Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company focused on developing and commercializing novel treatments for dermatologic conditions, announced today that its proprietary gels, IVR 101 and IVR 102, were successful in delivering fungicidal active ingredients efficiently through the human nail in a standard model.
Ivrea, using IVR 101 and IVR 102, seeks to achieve the efficacy of oral medications and the safety of topical applications for the successful treatment of onychomycosis. IVR 101 and IVR 102 are topically applied gels which deliver active ingredients efficiently through the nail to the site of the fungal infection without the build-up of layers of lacquer on the nail, and with less likelihood of irritation.
The well-known fungicidal allylamines terbinafine and naftifine were each studied at 2% and 6% concentrations to determine the in vitro penetration and permeation through human cadaver nails. The following data are expressed as the mean +/- the standard deviation. The 21-day cumulative penetration (measured in micrograms) of terbinafine was 26.8 +/- 9.7, and 46.6 +/- 20.3, for the 2% and 6 % formulations respectively. The corresponding values for the naftifine 2% and 6% formulations were respectively, 26.0 +/- 11.7 and 38.6 +/- 11.3. The levels of the allylamines within the nail at day 21 (measured in micrograms/milligram) were 0.17 +/- 0.05 and 1.01 +/- 0.01 for the 2% and 6% terbinafine formulations, respectively. The corresponding values for the naftifine 2% and 6% formulations were 0.26 +/- 0.18 and 0.57 +/- 0.18. The data suggest that the mean fungicidal concentrations, for each active ingredient at both the 2% and 6% concentrations, have been significantly exceeded, both in the nail, in a freely available form, and beneath the nail.
"The Ivrea team is very encouraged that IVR 101 and IVR 102 have been shown, in this study, to deliver such high concentrations of known fungicidals through the nail," said Dan Lynch, Ivrea's CEO. "With these results, coupled with the recently completed enrollment of our Phase II clinical trial, we remain optimistic that the combination of our proprietary gels with known highly-active fungicidal ingredients will allow Ivrea to create unique prescription products that offer an unparalleled combination of efficacy, safety and convenience for the treatment of onychomycosis."