MonoSol Rx released recent updates on the development of its product, PharmFilm Tadalafil, designed for the treatment of both benign prostatic hyperplasia (BPH) and erectile dysfunction (ED). The company declared that they have successfully finished a pilot Pharmacokinetic (PK) study and received positive results from its meeting with the U.S. Food and Drug Administration (FDA) to continue development of the product.
BPH is the most common prostate disease, affecting approximately 210 million adult males worldwide as of 2010, according to a study published in The Lancet journal. Although BPH and erectile dysfunction (ED) are separate problems, from a therapeutic viewpoint, drugs used for ED may be useful in treating BPH symptoms. Among these, tadalafil is a drug used to inhibit an enzyme called phosphodiesterase type 5 (PDE5) present in smooth muscle cells lining the blood vessels supplying the erectile tissues of the penis.
Because PDE5 is also found in the lining of lungs’ smooth muscles, PDE5 inhibitors like tadalafil are used for the treatment of pulmonary arterial hypertension (PAH). Tadalafil is currently available as pills for the treatment of ED and BPH under the brand name Cialis, and for the treatment of PAH under the brand name Adcirca.
As the MonoSol Rx‘s technology, PharmFilm, is designed to benefit patients with efficient, safe, and convenient pharmaceuticals, PharmFilm Tadalafil will be provided in one single pack doses easy to transport, discrete, and can be taken with or without water.
“We are extremely pleased with the progress we have made in the development of PharmFilm Tadalafil,” said Keith Kendall, CEO of MonoSol Rx in the press release. “The success of our pilot PK study and positive outcome of our FDA meeting are important milestones in the development program, and we look forward to its further advancement.”
MonoSol Rx is a pharmaceutical company leveraging its proprietary PharmFilm technology delivering drugs in films to address patients needs and improve their outcomes. The company is seeking partnership opportunities for PharmFilm Tadalafil and is currently associated with ESC Advisors, a division of KEMA Partners LLC.