Most Recent Articles by Da Hee Han, PharmD
The guidelines were developed by over 100 experts, including hematologists, patient representatives, and other specialists.
NRX-101 combines D-cycloserine (DCS), an N-methyl-D-aspartate (NMDA) receptor antagonist, and lurasidone, a D2/5-HT2a receptor antagonist.
Researchers at the National Institute of Environmental Health Sciences (NIEHS), Vanderbilt University Medical Center, and the Henry Ford Health System analyzed patient data from African-American women aged 23 to 35 years (N=1553) who were participating in the NIEHS Study of Environment, Lifestyle, and Fibroids (SELF).
Approval from the Food and Drug Administration (FDA) was supported by the Phase 3 Replenish trial which evaluated the safety and efficacy of Bijuva in generally healthy, postmenopausal women with a uterus for the treatment of moderate to severe hot flashes.
The expanded approval was supposed by safety and efficacy data from the Phase 3 ACCESS IUS trial (N=1751) in women receiving Liletta. In the trial, Liletta demonstrated >99% efficacy in preventing pregnancy for up to 5 years in a broad patient population.