Lacosamide Pain UCB Pharma

On 25 September 2008, UCB Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lacosamide Pain UCB Pharma, for the treatment of diabetic neuropathic pain in adults.

What is Lacosamide Pain UCB Pharma?

Lacosamide Pain UCB Pharma contains the active substance lacosamide. It was to be available as tablets.

Lacosamide has been authorised in the European Union (EU) as an anti-epileptic medicine under the trade name Vimpat since August 2008.

What was Lacosamide Pain UCB Pharma expected to be used for?

Lacosamide Pain UCB Pharma was expected to be used in adults to treat pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes).

How is Lacosamide Pain UCB Pharma expected to work?

The exact way in which lacosamide works is still unclear, but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells. Lacosamide is also thought to be involved in the development of nerve cells that have been damaged. Together, these actions are expected to prevent abnormal electrical activity in nerve cells, reducing pain due to nerve damage.

What documentation did the company present to support its application to the CHMP?

The effects of Lacosamide Pain UCB Pharma were first tested in experimental models before being studied in humans.

The effectiveness of three doses of Lacosamide Pain UCB Pharma (200, 400 and 600 mg per day) was compared with that of placebo (a dummy treatment) in a total of 1,724 patients in four main studies. In all four studies, the dose of Lacosamide Pain UCB Pharma was increased gradually over a few weeks before being maintained at a stable dose for 12 weeks. The main measure of effectiveness was the change in pain levels between the start of the study and the last four weeks on the stable dose. Pain was measured by the patients on an 11-point scale.

How far into the evaluation was the application when it was withdrawn?

The application was at day 181 when the company withdrew. After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.

The CHMP normally takes up to 210 days to evaluate a new application. Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company. Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180. Following the CHMP’s opinion, it usually takes around two months for the European Commission to grant a licence.

What was the recommendation of the CHMP at that time?

Based on the review of the data and the company’s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Lacosamide Pain UCB Pharma could not have been approved for the treatment of diabetic neuropathic pain in adults.

What were the main concerns of the CHMP?

The CHMP was concerned that the studies had not shown a meaningful benefit of Lacosamide Pain UCB Pharma. The medicine can also cause side effects affecting the heart and central nervous system (such as dizziness), which are of concern in patients with diabetes.

Therefore, at the time of the withdrawal, the CHMP’s view was that a benefit of Lacosamide Pain UCB Pharma had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.

What were the reasons given by the company to withdraw the application?

The letter from the company notifying the EMEA of the withdrawal of the application is available under the tab 'All documents'.

What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Lacosamide Pain UCB Pharma?

The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Lacosamide Pain UCB Pharma. If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.

What is happening with Vimpat used for the treatment of epilepsy?

This withdrawal has no consequences on Vimpat, for which the balance of benefits and risks remains unchanged.

UCB Pharma withdraws its marketing authorisation application for Lacosamide Pain UCB Pharma

The European Medicines Agency (EMEA) has been formally notified by UCB Pharma S.A. of its decision to withdraw the application for a centralised marketing authorisation for the medicine Lacosamide Pain UCB Pharma (lacosamide) film-coated tablets.

Lacosamide Pain UCB Pharma was expected to be used for the treatment of diabetic neuropathic pain in adults.

The application for marketing authorisation for Lacosamide Pain UCB Pharma was submitted to the EMEA on 15 August 2007. At the time of the withdrawal it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).

In its official letter, the company stated that the withdrawal of Lacosamide Pain UCB Pharma was based on the view of the CHMP that a relevant effect of lacosamide in diabetic neuropathic pain has not been convincingly established.

More information about Lacosamide Pain UCB Pharma and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the EMEA website in due course.

Note

• Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.