FDA approves expanded use of Saphris
WHITEHOUSE STATION, N.J. Merck’s supplemental drug applications for its atypical antipsychotic received approval from the Food and Drug Administration, the drug maker said.
Saphris now is indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, Merck said.
Saphris initially was approved by the FDA last summer for the acute treatment of schizophrenia in adults and as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.
“These FDA approvals demonstrate our active commitment to further understand how our medicines can be used to help physicians help their patients, and we look forward to discussing these new uses for Saphris with the mental health community,” said David Michelson, VP neuroscience clinical research at Merck.
Greenstone, Eisai to launch authorized generic of Aricept
PEAPACK, N.J. The generics division of Pfizer will sell an authorized generic version of a drug used to treat dementia.
Greenstone said Wednesday that it had agreed with Eisai to launch donepezil hydrochloride tablets, an authorized generic of Aricept. The drug is used to treat dementia related to Alzheimer’s disease. Eisai makes the drug under a partnership with Pfizer.
“We are excited about the opportunity to work with Eisai to introduce this important authorized generic to patients,” said James Cannon, Greenstone’s VP business alliances. “First and foremost, our goal is to provide donepezil hydrochloride tablets to the broad customer base, and we also strive to remain competitive with other potential generic versions of the product.”
Unlike generic drugs, which are marketed in competition with their branded counterparts and must undergo an abbreviated regulatory approval process through the Food and Drug Administration, authorized generics are essentially branded drugs marketed under their generic names with the authorization of the original drug’s manufacturer and often through third-party companies.
Lack of sleep may increase IFG risk, study finds
NEW YORK Lack of beauty sleep may up one’s risk of developing a condition that leads to diabetes and heart disease, a new study found.
Researchers from Warwick Medical School and the State University of New York at Buffalo examined six years of data from 1,455 participants in the Western New York Health Study, all of whom were between the ages of 35 and 79 years, and found that people who sleep less than six hours a night may be three times more likely to develop incident-impaired fasting glycaemia. IFG causes the body to be unable to regulate glucose as efficiently as it should.
Lead author at Warwick Medical School Dr. Saverio Stranges said: "We found that short sleep, less than six hours, was associated with a significant, threefold increased likelihood of developing IFG, compared [with] people who got an average of six to eight hours sleep a night. Previous studies have shown that short sleep duration results in a 28% increase in mean levels of the appetite stimulating hormone ghrelin so it can affect feeding behaviors. Other studies have also shown that a lack of sleep can decrease glucose tolerance and increases the production of cortisol, a hormone produced in response to stress."
Stranges added that, "more research is needed, but our study does suggest a very strong correlation between lack of sleep and Type 2 diabetes and heart disease."
The study was published in the journal Annals of Epidemiology.