Risperdal Consta - Benzisoxazole Derivative Tablets
From European Union - EU Products Using Alkermes Technologies
Risperdal Consta (risperidone) is a benzisoxazole derivative with potent combined serotonin 5HT2A and dopamine D2 receptor-blocking properties. It is an effective atypical antipsychotic that is well tolerated, based on extensive clinical experience including long-term use. The authorised formulation of Risperdal Consta is a prolonged-release formulation for intramuscular (i.m.) injection containing 12.5, 25, 37.5, or 50 mg risperidone.
Product Details
The intramuscular long-acting injection (LAI) formulation provides slow and steady release of risperidone over a period of several weeks. The Referral procedure under Article 30 of Directive 2001/83/EC, as amended for Risperdal Consta was initiated in order to resolve divergences amongst the nationally authorised Product Information texts across the EU and EEA Member States, in particular with respect to indications, special warnings and precautions for use and interaction with other medicinal products and other forms of interaction. The CHMP assessed the proposed wording provided by the MAH, and particular attention was given to the following issues:
For section 4.1, the indication “schizophrenic disorders” was assessed in details, as the existing divergences were likely to have implications for the selection of the treatment population and for the dose regiment and concomitant treatments. The CHMP assessed the MAH responses and the submitted data, noting that Risperdal Consta was developed for the maintenance treatment of schizophrenia and adopting a harmonised wording that conveys the concept of a therapy to be administered after a disease has been brought under control. It was considered shown that it is not mandatory for patients to have been stabilised on oral medications, and even preferable that patients be switched to the long-acting injectable Risperdal Consta treatment, to increase adherence to the treatment. However, the CHMP requested the MAH to further discuss the proposed wording of the indication, and the need to establish tolerability with oral risperidone prior to initiating treatment with Risperdal Consta. The MAH provided further justifications, being of the position that restricting the use of Risperdal Consta to patients with an initial treatment response to oral risperidone would be unjustified and would introduce an unnecessary and potentially prolonged additional step for the prescribing physicians, delaying access of Risperdal Consta to those patients who may not be adherent to their oral medication and who may be among the most suitable candidates for a long-acting injectable medication. Based on the submitted data, the CHMP was of the opinion that the presented clinical data show that patients stabilised with any antipsychotic medication (oral or depot formulations) can safely be switched to Risperdal Consta and achieve a clinical benefit similar to that seen in patients being switched from oral risperidone and without a higher incidence of clinical deterioration.
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