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MonoSol Rx Developing Migraine Product for Treatment of Pain and Nausea in a Single Dose

Proprietary, Intellectual Property Protected Formulation Fills a Significant Unmet Patient Need

WARREN, N.J., Sept. 13, 2012 (GLOBE NEWSWIRE) — MonoSol Rx, LLC (“MonoSol Rx”), the developer of PharmFilm® drug delivery technology, today announced that it is developing a new drug product for the treatment of migraines. The migraine treatment drug candidate, MSRX-202, utilizes MonoSol’s PharmFilm® technology in a combination product that includes rizatriptan for the treatment of migraine pain and ondansetron for the treatment of nausea.

A. Mark Schobel, President and Chief Executive Officer of MonoSol Rx, stated, “MSRX-202 represents a truly innovative approach to migraine treatment that addresses both pain and nausea. Forty-five percent (45%) of migraine sufferers have bouts of nausea, and thirty percent (30%) suffer from vomiting. Approximately half of the CNS physicians who prescribe medication for migraine pain also prescribe anti-emetic medication, and one-quarter of primary care physicians do the same. Despite the high percentage of patients who suffer from all of these symptoms, there is no treatment available today that delivers relief from pain, nausea, and vomiting. MSRX-202 fulfills this unmet patient need and additionally has the potential to be the fastest acting oral migraine pain medication on the market.”

“Our preclinical and first-in-man pharmacokinetic studies indicate that the therapeutic dose will provide relief from pain in as little as fifteen minutes without the use of a device. This positions MSRX-202 to address two of the top concerns of patients and physicians: how quickly migraine pain goes away and how to minimize the impact of migraines on the patient’s daily life. We also believe there is the potential for our efficacy studies to show a higher percentage of patients with pain relief at two hours based upon the performance of the product thus far.”

MSRX-202 utilizes MonoSol Rx’s proprietary platform, PharmFilm®, to deliver a therapeutic dose which dissolves in less than twenty seconds. Preclinical and first-in-human pharmacokinetic studies indicate that MSRX-202 will reach therapeutic levels for rizatriptan in as little as fifteen minutes while maintaining the well-known pharmacokinetic profile of ondansetron. The product is covered by MonoSol Rx’s existing patent portfolio for PharmFilm®, as well as other pending patent applications related to the product candidate.

Mr. Schobel continued, “We are taking drug delivery innovation in the migraine space to a whole new level. Simply matching the profile of an existing molecule in an alternate delivery form is no longer sufficient given today’s market dynamics. You have to understand the value proposition your product brings to the patient, payers, and the industry. We have done this with MSRX-202 and we continue to receive significant interest in this formulation from physicians, clinicians, pharmaceutical companies, and investors. We are now actively working to identify the right marketing partnership for commercialization of the product.”

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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