Merck announced that the U.S. Food and Drug Administration (FDA) has approved two supplemental new drug applications (sNDA's) for SAPHRIS® (asenapine) sublingual tablets to expand the product's indications. SAPHRIS is now 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. SAPHRIS was initially approved in the United States on August 13, 2009 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, M.D., vice president of Neuroscience Clinical Research, Merck.
About Bipolar I Disorder and Schizophrenia
Bipolar I disorder (also known as manic-depressive disorder) is a chronic, episodic illness characterized by mania (episodes of elevated moods, extreme irritability, decreased sleep and increased energy), depression (overwhelming feelings of sadness, suicidal thoughts), or a combination of both.
Schizophrenia is an often chronic and disabling brain disorder. It's characterized by various symptom domains, such as so-called positive symptoms (including hallucinations, delusions and disordered thinking) as well as negative symptoms, cognitive impairment and other general psychopathological symptoms (such as anxiety or depression).
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships that donate and deliver our products to the people who need them. For more information, visit www.merck.com.