MonoSol Rx Launches Clinical Study of MSRX-110 Oral Film for Testosterone Replacement

- PharmFilm® Technology Targets New Treatment Option for Hypogonadism -

Warren, NJ (August 18, 2014) – MonoSol Rx, the developer of PharmFilm® drug delivery technology, today announced that it has begun enrolling patients with hypogonadism in an adaptive design Phase I/II clinical trial of MSRX-110, the Company’s testosterone replacement product candidate delivered via PharmFilm® oral film.  MSRX-110 is being developed for the treatment of hypogonadism, or low testosterone.  Hypogonadism is a condition that is estimated to affect approximately 20% of the U.S. male population over age 50 and is characterized by reduced or deficient secretion of testosterone which can lead to symptoms such as loss of libido, adverse changes in body composition, irritability and poor attention span.

The Phase I/II adaptive design clinical trial is designed to evaluate the bioavailability of MSRX-110 in patients diagnosed with hypogonadism. The trial is expected to enroll up to 36 patients in Canada.  The pharmacokinetics and patient response to MSRX-110 will be evaluated following a single-dose crossover study phase, a dose-response steady state phase and a dose adjustment steady state phase over a five-week period.

A. Mark Schobel, Co-President and Chief Executive Officer of MonoSol Rx, stated, “The initiation of this trial represents a significant milestone for MonoSol Rx and reinforces our position as a leader in the transmucosal soluble film pharmaceutical market.  PharmFilm®, a patent-protected, proprietary drug delivery technology developed by MonoSol Rx, is a quick-dissolving, commercially available ultra-thin method for delivering drugs orally to the mucous membranes of the mouth, cheek or under the tongue.”

About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to develop products which address the unmet needs of patients.  PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs.  The Company’s leadership in film drug delivery is supported by strong intellectual property, a pipeline of prescription formulations based on PharmFilm® technology, and two FDA approvals - Zuplenz®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone® sublingual film, the first sublingual film product for the treatment of opioid dependence.  For press releases and other company information, visit www.monosolrx.com.

* PharmFilm is a registered trademark of MonoSol Rx.

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