The Agency recommended performing a new Phase 3 trial with less restrictive entry criteria. On October 8, 2010, Boehringer announced that it would discontinue its development of flibanserin in light of the FDAs decision.Sprout responded to the FDAs cited deficiencies and refiled the NDA in 2013. The submission included data from a new Phase 3 trial and several Phase 1 drug-drug interaction studies. The FDA again refused the application, citing an uncertain risk/benefit ratio. In December 2013, a Formal Dispute Resolution was filed, which contained the requirements of the FDA for further studies. These include two studies in healthy subjects to determine if flibanserin impairs their ability to drive, and to determine if it interferes with other biochemical pathways. The Agency agreed to call a new Advisory Committee meeting to consider whether the risk-benefit ratio of flibanserin was favorable after this additional data was obtained. Sprout expected to resubmit the New Drug Application (NDA) in the 3rd quarter of 2014.On June 4, 2015, the US FDA Advisory Committee, which includes the Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management Advisory Committee (DSRM), recommended approval of the drug by 18–6, with the proviso that measures be taken to inform women of the drugs side effects. On August 18, 2015, the FDA approved Addyi (Flibanserin) for the treatment of premenopausal women with low sexual desire that causes personal distress or relationship difficulties.
Availability
Since 2009, lansoprazole has been available over the counter (OTC) in the U.S. as Prevacid 24HR and as Lansoprazole 24HR. In Australia, it is marketed by Pfizer as Zoton. Research
In vitro experiments have shown that lansoprazole binds to the pathogenic form of tau protein. As of 2015 laboratory studies were underway on analogs of lansoprazole to explore their use as potential PET imaging agents for diagnosing tauopathies including Alzheimers disease. References
External links
"Lansoprazole". Drug Information Portal. U.S. National Library of Medicine.