MonoSol Rx and Midatech's joint venture (dubbed MidaSol, of course) has some good news for its transbuccal insulin film. Phase I trials of Midaform produced positive bioavailability and pharmacokinetic results for the film, the companies said this week.
Midaform uses MonoSol's PharmFilm delivery platform, a quick-dissolving mucoadhesive film that allows APIs to be absorbed through the cheek. By loading PharmFilm with nanoparticle-stabilized insulin, the companies hope to provide a solution for patients for whom subcutaneous insulin delivery is unpleasant or impossible. And the Phase I results, scheduled to be presented in full at the European Summit for Clinical Nanomedicine that ends today, demonstrate just that, the companies said. Not only were bioavailability and pharmacokinetic results positive, but the stamp-sized film took effect faster in the 27 volunteers than normal subcutaneous treatment.
"The rapid onset of action surpassed our expectations, and we look forward to further clinical development of this exciting and groundbreaking product," MonoSol CEO A. Mark Schobel said in a statement. "Based on the success of this in-man study ... we look forward to accelerating the entire product-development program."
Neither MonoSol nor Midatech specified when Midaform might hit the market, but after January's animal trials, the film is moving quickly toward an FDA filing.
- read the companies' release