Sycrest (asenapine) is now available in the UK as a fast-dissolving sublingual tablet for the treatment of moderate-to-severe manic episodes associated with bipolar I disorder in adults.
Sycrest is the first tetracyclic antipsychotic, structurally unrelated to existing atypical antipsychotics.
Bipolar disorder affects close to 30 million people worldwide, and an estimated 623,000 people in the UK.
A new piece of patient insight research from the UK, with 988 respondents, has shown that many bipolar patients have concerns about their current treatment, with 44% of patients not satisfied with its efficacy.
“Coping with bipolar I disorder presents a very different challenge for each individual,” said Alison Cairns from Bipolar Scotland, Suzanne Hudson from Bipolar UK and Margaret Edwards from SANE.
“An increased number of treatment options give patients and their health professionals the best chance of finding the right treatment for them, and Bipolar Scotland, Bipolar UK and SANE today welcome the addition of another treatment for bipolar I patients in UK.”
The efficacy of Sycrest was demonstrated in two similarly-designed, three-week, double-blind, randomised, placebo- and active-controlled (olanzapine) monotherapy trials.
Rapid efficacy was shown as early as day two in clinical trials and Sycrest demonstrated superior efficacy to placebo in the reduction of manic symptoms associated with bipolar I disorder in adults over three weeks.
This efficacy was sustained over 12 weeks in a subsequent double blind extension study.
Furthermore, depressive symptoms associated with manic episodes, such as feelings of guilt and suicidal thoughts, may be associated with persistent functional impairment, and post hoc analyses of the three-week trials showed that Sycrest, but not olanzapine, significantly improved depressive symptoms compared with placebo at day seven.
Further results from the patient insight research showed that unwanted weight gain was one of the most common side effects, reported up to 79% of bipolar patients.
In addition, over a third (40%) of patients were prompted to switch medication as a result of side effects associated with existing antipsychotics.
Unwanted weight gain is a well-established side effect of antipsychotic treatments, the mainstay of bipolar treatment.
In clinical trials, fewer patients experienced clinically significant weight gain (≥7% increase in weight) with Sycrest compared with olanzapine.