An experimental antiviral drug Ebola physicians requested access to has been authorized by the Food and Drug Administration for Thomas Eric Duncan, the Dallas patient diagnosed with Ebola and admitted to Texas Health Presbyterian Hospital in critical condition. The drug, brincidofovir, is an oral antiviral medicine developed by Chimerix Inc., a North Carolina based drugmaker, and represents an emergency step in treating one of the most high profile Ebola cases to reach U.S. soil.<\/p>\n
Brincidofovir is an experimental antiviral drug Ebola researchers identified as a potential candidate based on laboratory test results suggesting activity against the virus. The drug is currently in late stage testing for several other types of viruses, including one that infects patients undergoing bone marrow transplants. Chimerix is also working with the U.S. Department of Defense on developing the drug as a potential treatment against smallpox.<\/p>\n
The Durham, North Carolina based company confirmed that physicians sought FDA emergency authorization to use brincidofovir in the Dallas patient. The FDA grants emergency access to unapproved drugs on a case by case basis, typically when a patient faces a life threatening condition for which no approved alternatives exist. As of the time of this report, the FDA had not approved any drugs or vaccines to safely and effectively treat Ebola.<\/p>\n
Thomas Eric Duncan was diagnosed with Ebola in Dallas after recently arriving from Liberia \u2014 the first case of Ebola diagnosed on U.S. soil. His condition was described as critical, prompting physicians to seek access to an experimental antiviral drug Ebola protocols had not previously included in standard care.<\/p>\n
Chimerix stated it was working with the FDA to finalize plans for a formal Ebola study of brincidofovir. The company has no other products on the market or in clinical testing, making brincidofovir its sole lead drug candidate at the time of this report.<\/p>\n
Brincidofovir was not the only experimental antiviral drug Ebola patients received during the 2014 outbreak response. Two other experimental drugs developed specifically for Ebola were used in American patients, though their clinical impact remained unclear at the time.<\/p>\n
ZMapp, one of those drugs, had its small supply exhausted after being administered to a limited number of patients. Government officials indicated that additional supply would be available within approximately two months. A second drug, TKM Ebola from Tekmira Pharmaceuticals, had been used in at least one patient and was reported to be in limited supply.<\/p>\n
The use of brincidofovir under FDA emergency authorization highlights the critical role that clinical research plays in preparing for infectious disease outbreaks. According to the FDA’s expanded access guidelines<\/a>, emergency use of unapproved drugs is evaluated on a case by case basis and requires a documented, life threatening need with no available approved alternatives.<\/p>\n The Centers for Disease Control and Prevention consulted with U.S. hospitals about more than 100 potentially suspicious cases during this period. More than a dozen were considered serious enough to warrant Ebola blood tests. Only the Dallas patient tested positive.<\/p>\n At FOMAT, we actively support clinical research in infectious disease and antiviral development across the United States. Studies like those involving brincidofovir illustrate why ongoing investment in Phase I through IV clinical trials for infectious disease treatments is essential for public health preparedness. Federal officials stated they were confident in their ability to manage any additional cases arriving in the United States, emphasizing that robust containment protocols were already in place.<\/p>\n <\/p>\nClinical Research in Infectious Disease at FOMAT<\/h3>\n