Tpoxx, the antiviral monkeypox treatment that's difficult for patients to get, is entering a phase 3 clinical trial sponsored by the National Institute of Allergy and Infectious Diseases.
SIGA Technologies' drug, tecovirimat, is only approved for smallpox, but some patients with monkeypox are eligible for a prescription — but only after their physician enrolls in the clinical trial and fills out a stack of paperwork for each patient.
If Tpoxx is proven effective in this 500-person, late-stage trial, it could be a big win for expanding access and mitigating the monkeypox outbreak, which has infected more than 21,000 people in the U.S.
"Monkeypox can be an extremely painful infection that lasts for weeks," NIAID Director Anthony Fauci, MD, said in a Sept. 9 news release from the National Institutes of Health. "We currently lack efficacy data that would help us understand how well this drug may mitigate painful monkeypox symptoms and prevent serious outcomes. This clinical trial was designed to answer those important questions."
The trial, which began enrolling adults and children Sept. 9, will test Tpoxx's efficacy, its "impact on pain scores, rate of progression to severe disease" and overall safety, according to the NIH.