Urgent Updates | March 16

FDA Accepts Application for Topical Molluscum Treatment
The Food and Drug Administration has accepted a new drug application for berdazimer gel 10.3% for the treatment of molluscum contagiosum, the manufacturer announced on March 7. The treatment was evaluated in the B-SIMPLE4 study, a phase 3 clinical trial including 891 individuals, showed that after 12 weeks of treatment, 32.4% of patients in the berdazimer group met the primary outcome of complete clearance of all lesions, versus 19.7% of those on the vehicle (P < .001).
Full Access: Medscape

FDA Panel Gives Unanimous Thumbs Up to OTC Naloxone
members of a joint Food and Drug Administration (FDA) advisory committee gave the green light to an over-the- counter (OTC) version of prescription naloxone nasal spray, an opioid overdose reversal agent. Their proposed OTC naloxone is identical to the prescription version with respect to intranasal delivery, dose, formulation, product quality, and active pharmaceutical ingredient.
Full Access: Medscape

Hospital Outcomes of Community-Acquired SARS-CoV-2 Omicron Variant Infection Compared With Influenza Infection in Switzerland
COVID-19 remains deadlier than influenza in severe cases requiring hospitalization, a new study shows. People who were hospitalized with Omicron COVID-19 infections were 54% more likely to die, compared to people who were hospitalized with the flu, Swiss researchers found.
Full Access: JAMA

COVID pill is first to cut short positive-test time after infection
Trial data show that an antiviral called ensitrelvir shortens symptoms of mild to moderate COVID-19 by about a day, and is the first drug to make a statistically significant cut to the number of days people test positive for SARS-CoV-2. The antiviral ensitrelvir, which is not approved in the United States, shortens symptoms in people with mild COVID and might reduce risk of long COVID — but more data are needed.
Full Access: Nature