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August 17th, 2009
Saphris Sublingual Tabs Receives FDA Endorsement

The US FDA has approved Saphris sublingual tablets for the acute therapy of schizophrenic adults, as well as the acute therapy of manic or mixed bipolar I disorder, with or without adult psychotic attributes.  Saphris is endorsed for first-line therapy, and is the first prescription drug to receive primary consent for both of these symptoms concurrently.

Shering-Plough, the research company behind Saphris are overly “pleased with the U.S. approval of Saphris, which represents an important new  choice for acute treatment of schizophrenia and acute manic or mixed episodes of bipolar I disorder in patients starting treatment and those who have discontinued previous treatment.”  Schering – Plough Research Institute, executive vice president and president Thomas P. Koestler, PhD went on to express their excitement with Saphris’ addition to their “product portfolio, and represents the first U.S. approval resulting from Organon/Schering – Plough combination.”

The FDA endorses Saphris, issues from a New Drug Application that contains efficacy data from their clinical study program which encompassed roughly 3,000 schizophrenic and mania trial patients.  Saphris’ new drug application was also reinforced by safety data issued from 4,500 people, some of which were treated for over two years.  The FDA’s endorsement stems from acute schizophrenia trials, where Saphris showed noteworthy statistical efficacy when compared with placebo and acute bipolar l disorder studies, in which, Saphris proved statistically, an immense lowering of bipolar symptoms versus that of the placebo trials.


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