Dexamed and associated names - referral

Current status

European Commission final decision

Overview

On 22 May 2014, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Dexamed (dexamfetamine sulphate). The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Dexamed outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following countries: Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain and Sweden.

What is Dexamed?

Dexamed is a medicine that contains the active substance dexamfetamine sulphate. It is to be available as tablets (5 mg) for the treatment of children between 6 and 17 years of age who have attention deficit hyperactivity disorder (ADHD) and in whom methylphenidate (another medicine for ADHD) was not effective (second-line treatment). ADHD is a condition that mainly affects children, resulting in a persistent inability to concentrate, hyperactivity and impulsive behaviour.

Dexamfetamine belongs to a group of medicines called 'psychostimulants' and is thought to work by activating certain areas of the brain that control attention and concentration, thus helping to reduce impulsive behaviour.

Why was Dexamed reviewed?

Kohne Pharma GmbH submitted Dexamed to the UK medicines regulatory agency for a decentralised procedure. This is a procedure where one European country (the 'reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other European countries (the 'concerned Member States', in this instance Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain, and Sweden).

However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 10 June 2013.

The grounds for the referral were concerns raised by the Netherlands that Dexamed presents a higher risk for abuse and dependence compared with other ADHD treatments, and that the data submitted to support the application did not provide sufficient evidence to demonstrate its effectiveness as a second-line treatment for ADHD.

What are the conclusions of the CHMP?

Although the CHMP acknowledged that there is a risk of abuse and dependence with Dexamed, it concluded that the risk minimisation measures proposed to mitigate this risk are adequate. These conclusions were supported by a group of experts in childhood and adolescent behavioural problems consulted by the CHMP. The experts' group advised that while there is some evidence that medicines of the same type as Dexamed are more likely to induce dependence than other treatments for ADHD, based on clinical practice the risk of developing dependence in patients treated with dexamfetamine is considered to be low and could be adequately managed with appropriate risk minimisation measures.

These measures include starting and regularly monitoring treatment with Dexamed under the supervision of a doctor experienced in treating childhood and adolescent behaviour disorders. Educational material will be provided to doctors to help them decide if treatment with Dexamed is appropriate and to monitor patients receiving the medicine. Educational material will also be given to pharmacists, parents and carers to help them identify any potential abuse or improper use of Dexamed. Furthermore, the company that markets Dexamed will conduct additional studies on the risk of abuse for this medicine.

The CHMP also noted that evidence from studies and clinical practice is available to show that dexamfetamine is effective in ADHD, including in patients in whom other treatments have failed.

Therefore, based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Dexamed outweigh its risks for second-line treatment of ADHD and recommended that the marketing authorisation be granted in all concerned Member States.

The European Commission issued a decision on 06 August 2014.

Dexamed and associated names Article-29(4) referral - Questions and answers

Reference Number: EMA/709170/2013

Key facts

About this medicine

• Approved name:
  Dexamed and associated names
• International non-proprietary name (INN) or common name:
  dexamfetamine

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1375
• Type:
  Article 29(4) referrals

  This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Key dates and outcomes

• CHMP opinion date:
  22/05/2014
• EC decision date:
  06/08/2014

All documents

Opinion provided by Committee for Medicinal Products for human Use

Dexamed and associated names Article-29(4) referral - Annex III

Dexamed and associated names Article-29(4) referral - Questions and answers

Reference Number: EMA/709170/2013

European Commission final decision

Dexamed and associated names Article-29(4) referral - Assessment report

Reference Number: EMA/353952/2014

Dexamed and associated names Article-29(4) referral - Annex I

Dexamed and associated names Article-29(4) referral - Annex II

Dexamed and associated names Article-29(4) referral - Annex IV

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.