Saphris (Allergan/Lundbeck/Meiji Seika) contains the atypical antipsychotic asenapine, which acts as a dopamine D2 and serotonin 5-HT2A antagonist. The drug was originally developed by Organon and Schering-Plough, and became part of Merck & Co’s portfolio after the company’s $41bn acquisition of Schering-Plough in 2009.
Saphris received US approval for its first bipolar disorder indication in August 2009 and was launched in the US in October 2009. In September 2010, asenapine received its first EU approval, where Lundbeck retains all commercial rights to the brand. Lundbeck launched asenapine (under the brand name Sycrest) in the EU in April 2011. In December 2013, Allergan (formerly Forest Laboratories) announced that it would acquire exclusive rights from Merck & Co for Saphris in the US. The deal closed in January 2014.
Allergan indicated additional approvals for bipolar depression and maintenance, as well as the launch of a new lower dose for Saphris, in the first quarter of 2017. However, Saphris’s US label does not reflect the drug’s approval in bipolar depression.
LIST OF FIGURES
18 Figure 1: Saphris for bipolar disorder – SWOT analysis
19 Figure 2: Datamonitor Healthcare’s drug assessment summary for Saphris in bipolar disorder
20 Figure 3: Datamonitor Healthcare’s drug assessment summary for Saphris in bipolar disorder
27 Figure 4: Saphris for schizophrenia – SWOT analysis
28 Figure 5: Datamonitor Healthcare’s drug assessment summary of Saphris for schizophrenia
29 Figure 6: Datamonitor Healthcare’s drug assessment summary of Saphris for schizophrenia
31 Figure 7: Saphris sales for schizophrenia across the US, Japan, Germany, Italy, Spain, and the UK, by country, 2017–26
LIST OF TABLES
6 Table 1: Saphris bipolar disorder indication approvals
7 Table 2: Saphris drug profile
9 Table 3: Saphris pivotal trial data for the acute treatment of manic episodes in bipolar disorder
12 Table 4: Adverse events in ≥5% of Saphris-treated adult patients with bipolar mania in double-blind, placebo-controlled trials
13 Table 5: Adverse events in ≥5% of Saphris-treated adult patients with bipolar mania in a double-blind, placebo-controlled trial
14 Table 6: Trial data for Saphris as a maintenance therapy
16 Table 7: Overview of key pivotal trial data for Saphris in pediatric bipolar disorder patients
17 Table 8: Adverse reactions in ≥5% of Saphris-treated pediatric patients (10–17 years) with bipolar mania in a double-blind, placebo-controlled trial
23 Table 9: Saphris drug profile
25 Table 10: Saphris pivotal trial data in schizophrenia
32 Table 11: Saphris sales for schizophrenia across the US, Japan, Germany, Italy, Spain, and the UK, by country ($m), 2017–26
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