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MonoSol Rx Successfully Completes Pre-IND Meeting with the FDA for PharmFilm® Tadalafil

Company on-track for FDA approval in 2017

WARREN, N.J., Mar. 25, 2016 – MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm drug delivery technology to improve patient outcomes and address unmet needs, today provided an update on the development of PharmFilm Tadalafil for the treatment of erectile dysfunction. The Company has completed a pilot Pharmacokinetic (PK) study and, following a recent meeting with the U.S. Food and Drug Administration (FDA), plans on continuing its development efforts.

Tadalafil is a PDE5 inhibitor currently marketed in pill form for the treatment of erectile dysfunction and benign prostatic hyperplasia (BPH) under the brand name Cialis®, and for treatment of pulmonary arterial hypertension under the brand name Adcirca®. PharmFilm Tadalafil will be offered in single pack doses that can be carried easily without the necessity of a pill bottle. The product is discrete, portable, 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. “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 currently exploring partnership opportunities for PharmFilm Tadalafil and has engaged ESC Advisors, a division of KEMA Partners LLC, to manage the partnering process.

About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm drug delivery technology to develop products that improve patient outcomes and address unmet needs. PharmFilm can benefit patients by improving the efficacy, safety, and convenience of pharmaceutical and over-the counter products. MonoSol Rx ‘s leadership in film drug delivery is supported by strong IP protection, a robust pipeline of prescription drug formulations, and two FDA-approved products — Suboxone® (buprenorphine and naloxone) sublingual film and Zuplenz® (ondansetron) oral soluble film. For press releases and other company information, visit www.monosolrx.com. More information about PharmFilm can be found at www.pharmfilm.com.

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