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news.MonoSol Rx, the developer of PharmFilm drug delivery technology, with its partner Midatech Pharma, announced today that it has initiated a Phase 2a study for Midaform Insulin PharmFilm, MSL- 001, with the dosing of its first patient.
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Unlike traditional insulin injections, Insulin PharmFilm, the proprietary nanoformulated transbuccal insulin film product delivers insulin through the use of a rapidly dissolving mucoadhesive film that is placed on the inside of the cheek.
The trial is an open label, cross-over, seven arm study with the drug being delivered to patients via a buccal soluble film. The objectives of the study are to establish the pharmacodynamic and pharmacokinetic profile and safety and tolerability for MSL-001 in comparison to subcutaneous administered human recombinant insulin (Humulin).
The study is being conducted in Perth, Australia, with a total of 12 patients, male and female, aged 18 to 55 from a screening pool of up to 35 subjects. The Company expects the study to be completed within five months.
The Phase 1 trial showed that Midaform Insulin PharmFilm was safe and well tolerated at all dose levels tested.
MSL-001 was invented by MonoSol Rx and Midatech and is being developed by their joint venture, MidaSol Therapeutics. The product contains recombinant human insulin, which is non-covalently bound to glycan-coated gold nanoparticles and embedded in an oral, mucoadhesive, polymeric film for transbuccal delivery.
Keith Kendall, Chief Executive Officer said, "We continue to be excited about the prospects of our oral insulin product and the medical need it solves for patients that have long sought a needle-free insulin delivery."