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Javelin Pharmaceuticals Announces Successful Pivotal Phase 3 Trial,Data

to severe post-surgical pain enrolled at 7 sites in the United States. These patients received either 7.5 mg Rylomine every hour as needed, 15 mg Rylomine every three hours as needed, 7.5 mg IV morphine, or matching placebos. In this "blinded" study, patients received treatments of which the identity (active or placebo) was not known by either the Investigator or the patient, although patients did know whether they were receiving intravenous or intranasal treatment.

About Rylomine(TM)

Rylomine is a patient-controlled nasal spray that delivers a single metered dose of morphine, an opioid analgesic used for the treatment of moderate-to-severe pain. After use, a negligible amount of morphine remains in the dispenser, reducing the risk of scavenging and abuse of discarded devices. Data from clinical studies have demonstrated that Rylomine has similar efficacy to an infusion of intravenous morphine.

Parenteral morphine is the standard of care for management of acute moderate-to-severe pain, especially after surgery, when analgesic requirements vary between individuals and often fluctuate even in the same patient. IV morphine analgesia has rapid onset, proven efficacy, can accommodate variations in analgesic demand, and has side effects that are well understood by medical personnel. Morphine, like many drugs, is poorly absorbed across mucosal barriers and, in particular, the nasal membrane. Javelin's proprietary technology allows for nasal delivery of predictable therapeutic blood levels of morphine. The key to this technology is ChiSys(TM), a carbohydrate polymer that, while pharmaceutically inert by itself, enhances the absorption of compounds across mucosal membranes, such as in the nasal cavity. The contribution of ChiSys(TM) to enhancing mucosal drug absorption reflects several factors including its potent mucoadhesive property, which prevents drug washout. Rylomine is a novel formulation of morphine and ChiSys(TM) packaged in a single unit-dose
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