What is Tpoxx? The Monkeypox Treatment Drug That’s Hard to Get - The New York Times

Doctors who want to prescribe tecovirimat, or Tpoxx, must navigate a gantlet of bureaucratic hurdles that experts say could be quickly lifted.

The only drug available to treat monkeypox is so difficult to access that just a fraction of the nearly 7,000 patients in the United States have been given it.

The Food and Drug Administration approved tecovirimat as a smallpox treatment in 2018, based on safety data in people and efficacy data in primates — which, for the purposes of the trial, actually were infected with monkeypox.

Until the current outbreak, tecovirimat was given only rarely to monkeypox patients.

As a smallpox treatment, its use against monkeypox is considered experimental?

Gostin, an expert on public health law and director of the O’Neill Institute for National and Global Health Law at Georgetown University.

The Department of Health and Human Services on Thursday declared monkeypox a national health emergency.

In an article published in the New England Journal of Medicine on Wednesday, federal health officials defended their decision to treat tecovirimat as an investigational drug?

While acknowledging that animal data was promising and that the drug seemed safe in healthy patients, they wrote that, without large clinical trials, “we will not know whether tecovirimat would benefit, harm or have no effect on people with monkeypox disease.”.

Providing Tpoxx only as an investigational drug “ensures we have data from patients who use this drug,” she said.

On July 23, the World Health Organization declared monkeypox a global health emergency?

The monkeypox virus can spread from person to person through close physical contact with infectious lesions or pustules, by touching items — like clothing or bedding — that previously touched the rash, or via the respiratory droplets produced by coughing or sneezing.

If you get sick, the treatment for monkeypox generally involves symptom management.

It  has mostly been offered to health care workers and people who have had a confirmed or suspected monkeypox exposure due to limited supplies, though new doses should become available in the coming months.

Physicians who want to prescribe the drug must first sign up to become investigators in a clinical trial, sending in résumés and informed consent forms signed by monkeypox patients — a process that is “labor intensive and virtually impossible” for most doctors, said Lynda Dee, the executive director of AIDS Action Baltimore.

Thompson said he wanted her to note in his chart that she was unwilling to prescribe the drug for him, she told him the doctor would need to decide.

population, said many of her monkeypox patients had been turned away by three or four doctors who could not deal with the tortuous federal rules regarding tecovirimat.

She tried to acquire tecovirimat, but the Pennsylvania health department insisted the patient get an eye exam first.

Lane said of tecovirimat.

Lane and others said they understood that there were still questions about the drug’s safety and effectiveness in people, but noted that it had already been shown to be safe in people and had been approved by the F.D.A.

James Lawler, a director of the University of Nebraska’s Global Center for Health Security