Midazolam Autoinjectors Project Bioshield   3

The Department of Health and Human Services (HHS) has the responsibility of maintaining a definitive supply of medical Countermeasures for use in public health emergencies.The 2007 PHEMCE Implementation Plan for Chemical, Biological, Radiological, and Nuclear (CBRN) Threats called for updating the CHEMPACK formulary with improved medical countermeasures, such as anticonvulsants, as they became available. In 2011, the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) recommended that an improved anticonvulsant be developed and procured to address this need. Attributes of this product would include a non-IV route of administration (e.g. IM) that is fast acting, has greater efficacy than existing products, and is approved by the Food and Drug Administration (FDA) for adult and pediatric indications. More specifically, the PHEMCE recommended that all diazepam autoinjectors (Convulsant Antidote Nerve Agent, CANA) in the Strategic National Stockpile's (SNS) CHEMPACK Program be replaced with the improved anticonvulsant midazolam in an autoinjector for rapid intramuscular administration. The CHEMPACK Program addresses some significant challenges to preparedness for a nerve agent attack. Prepositioning antidotes throughout the country addresses the time constraint on effective medical treatment and thus reduces the time for delivery relative to the time to provide a 12-hour Push Package released from a strategically placed SNS site. SNS/CHEMPACKs account for all of the CANA acquired and maintained by the SNS specifically for the treatment of nerve agent-induced seizures. Development and acquisition of pediatric and adult midazolam autoinjectors, and their approval as a drug/device combination product for the treatment of status epilepticus in both populations, would fulfill the requirement to replace all existing diazepam autoinjectors in the SNS/CHEMPACKs with midazolam autoinjectors.

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