Lacosamide Pain UCB Pharma: Withdrawal of the marketing authorisation application

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.

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).

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.

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.

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.

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.

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.

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

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.

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