- June 3, 2018
- Posted by: PharmaScroll
On 31 May 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Rxulti, intended for the treatment of schizophrenia.
Rxulti will be available as film-coated tablets (0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg). The active substance of Rxulti is brexpiprazole, an antipsychotic that binds primarily to dopamine D2 receptors, serotonin 5-HT1A and 5-HT2A receptors and noradrenergic α1B/2C receptors (ATC code: N05AX16).
The benefits with Rxulti are its ability to improve psychotic symptoms. The most common side effects are akathisia and weight gain.
The full indication is: “Rxulti is indicated for the treatment of schizophrenia in adult patients”.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
Brexpiprazole was approved by the U.S. Food and Drug Administration in July 2015 to treat patients with schizophrenia and as an adjunctive treatment for patients with major depressive disorder. Brexpiprazole was subsequently approved in Canada, Australia and Japan for the treatment of schizophrenia. In all four countries brexpiprazole is distributed and marketed under the brand name REXULTI®.
Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. The mechanism of action for brexpiprazole in the adjunctive treatment of major depressive disorder or schizophrenia is not fully understood. However, the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. Brexpiprazole exhibits high affinity (sub-nanomolar) for these receptors as well as for noradrenaline alpha1B/2C receptors.
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News Source: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003841/WC500249801.pdf
Image source: https://www.huffingtonpost.ca/ken-rabow/schizophrenia-not-a-curse_b_12497426.html