Molnupiravir COVID-19 Pill

August 10, 2021
Molnupiravir COVID-19 Pill

Pandemic Pill?

A new antiviral may soon become part of the arsenal to fight the virus that causes COVID-19.
Here's a closer look and why it matters.

Molnupiravir

  • What? An oral antiviral treatment developed by pharma companies Merck & Co and Ridgeback Biotherapeutics.

  • How It Works: Slows/stops the virus from replicating, and overwhelming the body's immune system.
  • April 2020: Trials began. Phase 1 trials (tests the safety of a drug in healthy volunteers) exhibited positive results.

  • Phase 2 showed antiviral effective if given early in COVID-19 diagnoses. – study stopped in hospitalized patients.

The Latest

  • Oct. 1: Merck announced interim results from their Phase 3 trials.

  • Participants recently tested positive for COVID-19, had "mild-to-moderate" symptoms and at least one risk factor (e.g. diabetes, heart disease).

  • Molnupiravir reduced hospitalization or death by about 50%. After 29 days, no deaths were reported in those who took the antiviral twice a day for five days; eight deaths reported in the placebo group.

What's Next?

  • The company intends to apply for an emergency use authorization (EUA) from the FDA "as soon as possible."

  • What about variants? Merck reports: "… molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and Mu."

  • While Merck has summarized the results of its data, the public has not yet seen the detailed study results. This often occurs with official filing with the FDA.
"You want to make sure it doesn't cause genetic mutations … I need that efficacy data to help confirm …"

Nicholas Kartsonis, Merck's senior vice pres. of clinical research for infectious disease & vaccines, discussing potential birth defects earlier this year. While the company's information indicates the drug appears safe for use in most, molnupiravir was not studied in women who were/are pregnant; both men and women participating in the study were required to use contraceptives.

If authorized, molnupiravir will be the first oral antiviral available to help treat COVID-19 and could make an impact on the fight against the pandemic worldwide. In April, Merck announced it has voluntary agreements with manufacturing facilities that will supply the antiviral to India and over 100 lower- and middle-income countries, pending authorization/approval. In June, the Biden administration made a deal with Merck to purchase 1.7 million treatment courses of the antiviral pending authorization.

Sources for publishing:

Merck Announces Phase 3 Interim Analysis

Merck says COVID-19 pill cuts risk of death, hospitalization

New antiviral is highly effective study finds, and is stirring hope that COVID-19 could be treated by a pill

Click HERE for a good backgrounder on molnupiravir's backstory

HERE's a good explainer on how molnupiravir and other treatments work

by Jenna Lee,

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