Actavis has received approval from the US Food and Drug Administration (FDA) for its Saphris (asenapine).
Saphris has been approved as a monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in paediatric patients aged between ten and 17 years.
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Saphris is a second-generation atypical antipsychotic, which was initially approved in 2009. It is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy or as adjunctive therapy with either lithium or valproate, and for the acute and maintenance treatment of schizophrenia in adults.
According to Actavis, Saphris is the only atypical antipsychotic treatment option with a sublingual (under the tongue) formulation.
Actavis global R&D executive vice-president David Nicholson said: “We were pleased to see that Saphris was effective across a range of doses, in the largest registrational paediatric trial for an atypical antipsychotic in bipolar I disorder.
“Saphris is the first atypical antipsychotic to be approved for paediatric patients with bipolar I disorder in the last five years. As part of our commitment to mental health, we look forward to making this treatment option available to patients as soon as possible.”
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By GlobalDataFDA approval was based on the results of a three-week monotherapy trial in 403 paediatric patients aged between ten and 17 years, with 302 paediatric patients receiving Saphris twice-daily in doses of either 2.5mg, 5mg or 10mg.
Actavis noted that Saphris demonstrated improvement in Young Mania Rating Scale (YMRS) total score and Clinical Global Impression-Bipolar (CGI-BP) Severity of Illness overall score against placebo in a paediatric clinical trial.
The company plans to make Saphris available for paediatric patients with bipolar I disorder in 2.5mg, 5mg and 10mg black cherry flavour sublingual tablets in the second quarter of this year.
Image: Actavis Biologics Ltd, Estuary Banks, Liverpool. Photo: courtesy of Rept0n1x.
