Merck’s Molnupiravir, an oral antiviral treatment is set for review by the FDA Advisory Panel. If approved, Molnupiravir will be the first oral antiviral treatment authorized for the treatment of COVID-19. This experimental drug was developed by Merck and Ridgeback Biotherapeutics. This comes at the back drop of several drugs failing to prove their efficacy, in spite of initial promising trends. Molnupiravir is backed by a recent clinical study outcome highlighting that the drug has reduced the risk of hospital admissions and deaths by approximately fifty percent. But, the study is critiqued as something based on a small scale clinical trial, involving 775 participants. Credits – Content inputs from MedicialNewsToday.
Molnupiravir vs Placebo in a Randomized Phase III Trial
Among the 775 participants, 385 patients took Molnupiravir capsules for five days, twice daily. The choice of participants was based on the risk factors such as obesity, age above 60 years, diabetes and cardiovascular disease. Participants are patients with at least one risk factor and haven’t been admitted to the hospital. The results in favor of Molnupiravir seemed overwhelmingly positive that eventually made the manufacturing company to seek emergency use authorization. The trial is also being halted for new participants to be recruited. What are the trial outcomes or parameters that have inspired such confidence? Out of 385 patients who got Molnupiravir, only 28 required hospital administration. The number is almost double in the Placebo arm of study. More significantly, the deaths reported are zero for Molnupiravir while eight patients on Placebo died.
How does Molnupiravir work against COVID-19?
Molnupiravir is being reviewed as a safe and effective antiviral that can be taken outside clinical settings. Being an oral drug with convenient dosage recommendations, it is posed to be more convenient that other options like remdesivir, a drug which is no longer recommended by WHO. Classified under mutagenic ribonucleosides, Molnupiravir has a unique mechanism of action. This medication can cause mutation of the virus inside the host cells, leading to arrest their replication. This is possible by changing the genetic material or composition of the virus that are otherwise fast replicating. An error in the replication process of the genomic sequence induced by a mutagenic ribonucleoside drug can reduce the pace of virus replication. Ultimately the volume or load of virus can be contained, where by keeping the disease condition from worsening. This explains the study results or outcomes like significant reduction rate of hospitalization and deaths due to COVID-19.
From the perspective of an experimental drug being developed in the midst of a deadly pandemic, these results are certainly positive, if not absolutely overwhelming. But, it is also important to assess the concerns and criticisms around swift approvals and emergency use authorizations without sufficient review and due diligence.
