UCB Completes Mutual Recognition Procedure for Equasym™ XL
May 24, 2006
Brussels (Belgium) - UCB announced today that it had successfully completed the European Mutual Recognition Procedure (MRP) for Equasym™ XL for use in the treatment of the symptoms of attention deficit hyperactivity disorder (ADHD) with the UK acting as the Reference Member State for the MRP. All concerned member states endorsed the summary of product characteristics. The national marketing authorizations are expected to be issued over the coming months. Equasym™ XL was launched in the UK, the first European market in 2005.
Troy Cox, President CNS Operations, UCB said, ‘On the granting of national licences we look forward to making Equasym™ XL available as a valuable ADHD treatment option to patients, families and physicians in 12 more European countries. At UCB, we are committed to minimizing the impact of ADHD on children during their formative years.’
ADHD is a common neurobehavioural disorder that affects approximately three to seven percent of school-aged children.1 The three main symptoms of ADHD are inattention, hyperactivity and impulsivity. Children with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem.
About Equasym™ XL
Equasym™XL 10, 20 and 30 mg capsules is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder in children over six years of age when remedial measures alone prove insufficient. Equasym™ XL is designed to deliver therapeutic plasma levels for a period of approximately eight hours which is consistent with the school day rather than the whole day. Equasym™XL is contra-indicated in patients known to be hypersensitive to methylphenidate or to any of the excipients; in patients with marked anxiety, agitation or tension as the use of Equasym™ XL may aggravate these symptoms; in patients with glaucoma; in patients with hyperthyroidism; in patients with thyrotoxicosis; in patients with severe angina pectoris; in patients with cardiac arrhythmia; in patients with severe hypertension; in patients with heart failure; in patients with myocardial infarction; in patients who currently exhibit severe depression, psychotic symptoms, psychopathological personality structure, history of aggression or suicidal tendency, since methylphenidate might worsen these conditions; in patients with known drug dependence or alcoholism; in combination with non-selective, irreversible monoamine oxydase inhibitors, and also within a minimum of 14 days following discontinuation of a non-selective irreversible MAO inhibitor; in patients with motor tics, tics in siblings, or a family history or diagnosis of Tourette’s syndrome and during pregnancy. The most commonly reported adverse events in pivotal studies are insomnia and nervousness. Other commonly reported adverse events include arrhythmia, palpitations, tachycardia, abdominal pain, nausea, vomiting, dry mouth, decreased appetite, reduced weight gain during prolonged use, arthralgia, changes in blood pressure and heart rate, dizziness, drowsiness, dyskinesia, headache, hyperactivity, abnormal behaviour, aggression, agitation, anorexia, anxiety, depression, irritability, alopecia, pruritus, rash, and urticaria.2 This product is marketed in the US under the brand name Metadate™ CD and has received marketing approval in Finland.
UCB (www.ucb-group.com) is a leading global biopharmaceutical company dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology – UCB focuses on securing a leading position in severe disease categories. Employing over 8,500 people in over 40 countries, UCB achieved revenue of 2.3 billion euro in 2005. UCB is listed on the Euronext Brussels Exchange with a market capitalisation of approximately 6.0 billion euro. Worldwide headquarters are located in Brussels, Belgium.
1 National Institutes of Health Consensus Development Conference Statement: Diagnosis and
treatment of attention-deficit hyperactivity disorder (ADHD). J Am Acad Child Adolesc Psychiatry
2000: 39: 182-93
2 Summary of Product Characteristics Equasym™ XL
- Contact Information
- Jean-Christophe Donck
- Vice President, Corporate Communications and Investor Relations
- Contact via E-mail
This news content was configured by WebWire editorial staff. Linking is permitted.
News Release Distribution and Press Release Distribution Services Provided by WebWire.