Authors urge greater transparency of study results for drugs approved by the FDA
Zurzuvae works faster than conventional antidepressants and is easier to take than another postpartum depression drug that is delivered intravenously
For first three approved indications, second and third indication approvals less likely to have high value rating
While Leqembi did help reduce mental decline compared with placebo, the drug has been linked to two deaths from brain bleeds
Patients who received 2 or 3 mg of Rexulti had significant improvements in agitation scores compared with patients taking a placebo
Approval is for treatment of excessive daytime sleepiness with once-at-bedtime dosing
The spray can already be obtained without a prescription, but currently buyers must get it from a pharmacist
Findings seen for 21 drug approvals between 2018 and 2021, with only one-third needing postmarketing studies
Approval of Leqembi comes after controversial approval in 2021 of Aduhelm, which met with criticism over concerns about that drug's effectiveness, safety, pricing
Extrapolation of the findings from pivotal clinical trials to the approved indication most common for disease severity