Vyteris' Actyve effective infertility therapy, study says

By Elaine Rigoli

Tampa, Fla., Aug. 10 - Vyteris Holdings (Nevada), Inc. reported that data from two phase 1 clinical trials demonstrated that Vyteris' Actyve transdermal drug-delivery technology delivered potentially therapeutic levels of a peptide that is used for the treatment of human infertility.

Vyteris and its partner, Ferring Pharmaceuticals Inc., are in the early stages of developing a product that delivers the peptide for the treatment of female infertility. The development goal is that, through this technology, the peptide could be delivered 24 hours a day in short pulses, to induce ovulation, the companies explained in a news release.

In these phase 1 clinical trials, a pulsatile profile controlled the transdermal delivery of the peptide from patches loaded with different concentrations of the peptide, the release said.

The amounts of the peptide delivered were compared with subcutaneous (subQ) and intravenous (IV) infusions of the peptide in humans. The first study, with 45 healthy volunteers, used different formulations within the Vyteris patch that were compared with subQ and IV delivery of the peptide.

The plasma concentrations of the peptide demonstrated the feasibility of delivering the peptide in humans using the Actyve system. In addition, the pulses obtained were sharper and therefore mimicked an IV pulse profile more than a subQ pulse profile.

The second study, with 50 healthy volunteers, compared more formulations in the patch and iontophoretic delivery parameters against subQ infusion of the peptide in humans. The plasma profiles of the peptide obtained in the second study achieved potentially therapeutic levels and provided sharper profiles (closer to IV) than subQ profiles.

No unexpected adverse side effects were observed in any of the participants in the trials.

Vyteris is a specialty pharmaceutical company based in Fair Lawn, N.J.

Ferring Pharmaceuticals is a research-driven biopharmaceutical company with headquarters in Lausanne, Switzerland.

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