Diana Ernst, RPh, Author at MPR

Diana Ernst, RPh

All articles by Diana Ernst, RPh

Baricitinib Beneficial in Two Phase 3 Atopic Dermatitis Trials

Lilly and Incyte announced positive top-line results from two Phase 3 clinical trials evaluating baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis. Results from the BREEZE-AD1 and BREEZE-AD2 placebo-controlled trials showed that treatment with baricitinib monotherapy led to a statistically significant proportion of patients achieving Investigator’s Global Assessment for Atopic Dermatitis score of clear…

FDA Rejects Opioid System Modulator NDA for Depression Treatment

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Alkermes regarding the New Drug Application (NDA) for ALKS 5461, an investigational adjunctive treatment for major depressive disorder (MDD). ALKS 5461 is an oral medication that acts as an opioid system modulator and is being proposed for once-daily administration. It consists…