
| PIPELINE OUR TECHNOLOGY DYLOJECT™ RYLOMINE™ PMI-150 |
Our Technology We are developing differentiated pain control products that provide the flexibility and versatility required to adequately address the limitations of existing prescription pain pharmaceuticals. Each of our three late stage development product candidates utilizes different proprietary technologies to deliver benefit to the patient. Currently available formulations of the popular drug diclofenac are insoluble in water. Javelin has successfully improved the solubility of diclofenac by the addition of hydroxypropyl-beta-cyclodextrin (HPβCD) allowing for the creation of a proprietary injectable formulation that can efficiently deliver the drug to the patient’s bloodstream. Cyclodextrins, such as HPβCD, are ring-shaped carbohydrate molecules that can improve the solubility of poorly soluble drugs such as diclofenac. While there are many types of cyclodextrins, most are systemically toxic. Only modified cyclodextrins such as HPβCD are regarded as safe for injection. Javelin’s HPβCD is used in higher concentrations in the FDA-approved injectable antifungal drug, Sporanox®. Morphine, like many drugs, is poorly absorbed across mucosal barriers and, in particular, the nasal membrane. Javelin has a proprietary technology that allows for nasal delivery of predictable therapeutic blood levels of morphine. The key to this technology is ChiSys™, a carbohydrate polymer that, while pharmaceutically inert by itself, enhances the absorption of compounds across mucosal membranes such as those found in the nasal cavity. The contribution of ChiSys™ to enhancing mucosal drug absorption reflects several factors including its potent mucoadhesive property, which prevents drug washout. Ketamine, is an FDA-approved anesthetic agent for intravenous or intramuscular administration. It is the anesthetic agent of choice for use in trauma because of its favorable safety profile. The use of low dose ketamine as a pain medication has been reported in the medical literature and while not yet approved by the FDA, is gaining clinician acceptance as a result of its effectiveness at treating neuropathic pain and minimal impairment of cardiovascular and respiratory functions. Javelin has successfully developed a proprietary nasal formulation that can safely deliver subanesthetic blood levels of ketamine using a method of administration ideally suited for its innovative use as an pain medication.
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