"Rylomine is one of three late stage drug development candidates in our pipeline that address large underserved markets for pain management. It employs a patented formulation of intranasal morphine in a simple disposable device that requires no programming or special patient education," said, Dr. Daniel B. Carr, CEO and CMO. "While still in development, Rylomine has potential to become the non-invasive approach of choice for administering intermittent doses of morphine for post-surgical pain in medically supervised settings. Morphine is the reference standard for treatment of post-surgical pain, as well as pain from trauma and diseases including cancer."
Top line data from the first of two pivotal post-surgical Phase 3 clinical trials of Javelin's Rylomine is anticipated this summer.
According to the United States Department of Health and Human Services, orthopedic operations make up approximately 10% (7.4 million) of the 73.4 million ambulatory and in-patient surgical procedures in the United States annually.
Rylomine (intranasal morphine), is currently in Phase 3 development in the United States, for moderate-to-severe pain in supervised healthcare settings. It employs the patented and proprietary, Chysis(R) drug-delivery platform to adhere and regularize the kinet ics of morphine to and across the nasal mucosa. Each nostril can hold only 150-200 ul of administered drug candidate and requires approximately 15 minutes for the Rylomine to clear the nasal passages. This provides potential for substantial patient safety.
About Javelin Pharmaceuticals, Inc.
With US corporate headquarters in Cambridge, MA, and a European office in Cambridge, UK, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the pain management market. For additional information, please visit the website at www.javelinpharmaceuticals.com.
This press release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA (and foreign equivalent) review process and other governmental regulation, our ability to obtain working capital, our ability to successfully develop and commercialize drug candidates, and competition from other pharmaceutical companies.
Javelin Pharmaceuticals, Inc.
Investor Relations & Media
Rick Pierce, 617-349-4500
VP Investor Relations
June Gregg, 617-349-4500