Please login to the form below

Not currently logged in
Email:
Password:

Merck's Saphris cleared for new uses

Merck has won US Food and Drug Administration approval of new indications for its atypical antipsychotic Saphris

Merck has won US Food and Drug Administration (FDA) approval of new indications for its atypical antipsychotic Saphris (asenapine).

The sublingual tablets may now be marketed 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 won its initial US approval in mid-August of last year 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.

Earlier this month, the drug, which Merck markets as Sycrest outside the US, won approval throughout the EU for treating moderate to severe manic episodes in adult patients with bipolar I disorder. However, European authorities declined to approve the drug as a treatment of schizophrenia.

Saphris was acquired in late-stage clinical development by Schering-Plough as part of the company's 2007 merger with Organon International. Merck and Schering-Plough merged last year.

Merck has not yet reported sales figures for the recently launched drug.

8th September 2010

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Hanson Zandi

Hanson Zandi is a Creative and Digital Healthcare Agency. We combine 30 years’ experience with the enthusiasm of a start-up...

Latest intelligence

Ali Frederic Ben-Amor
Tackling a formidable foe
Ali Frederic Ben-Amor tells how Merck is taking the fight to multiple sclerosis...
Geoff
Cancer care – the power of new technologies
With patient numbers set to soar, how can we make a difference?...
image 1
Redefining communications excellence
How to be heard in today’s multichannel, multistakeholder, multimedia world...

Infographics