
On Dec 23, 2021, FDA gave Emergency Use Authorization to molnupiravir as outpatient treatment for COVID-19 in high-risk patients 18 and older. “High risk” means high risk for hospitalization or death from COVID-19. Users need a positive COVID-19 test and should start treatment as early as possible, within five days of symptom onset.
The drug reduced hospitalization and death by 30%. FDA approval was based on a clinical study that included only ~700 patients who got the pill. I assume there were 700 others who got a placebo.
By comparison, Pfizer’s Paxlovid reduced hospitalization and death by 90%.
The dose is 800 mg by mouth every 12 hours for five days. Available capsules contain 200 mg.
Notes:
- The drug is well-tolerated. Most common side effects are diarrhea, nausea, and dizziness.
- No known drug interactions. This is an advantage over Pfizer’s Paxlovid pill.
- No dose adjustment needed for kidney disease, liver disease, or old age. Another advantage over Paxlovid.
- The drug could be dangerous to embryos/fetuses. Don’t get pregnant while taking this! Male users need to use reliable birth control for the three months after use.
Click for FDA’s prescribing information.
Don’t ask me for the drug’s brand name or cost. I couldn’t find those. CNET says the U.S. Fedgov will provides some doses for “free.” I.e., the taxpayers are paying for it. More than 100 million U.S. households, or 61% of all taxpayers, paid no federal income taxes in 2020.
Steve Parker, M.D.
