Sliwens

Application withdrawn

The application for this medicine has been withdrawn

Overview

On 18 December 2009, Sanofi-Aventis officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Sliwens, for use in adults with chronic (long-term) insomnia who have difficulty staying asleep.

What is Sliwens?

Sliwens is a medicine that contains the active substance eplivanserin. It was to be available as tablets.

What was Sliwens expected to be used for?

Sliwens was expected to be used in adults with long-term insomnia (difficulty sleeping). It was to be used in patients who have difficulty staying asleep.

How was Sliwens expected to work?

The active substance in Sliwens, eplivanserin, is a 5-hydroxytryptamine receptor antagonist. It blocks receptors in the brain called 5-hydroxytryptamine type 2 receptors, which are involved in regulating the daily cycle of being asleep and being awake. By blocking these receptors, eplivanserin was expected to modify the sleep-wake cycle, helping people with long-term insomnia to stay asleep.

What documentation did the company present to support its application?

The effects of Sliwens were first tested in experimental models before being studied in humans.

The company presented results of four main studies involving over 3,000 adults who had difficulty staying asleep. The studies compared Sliwens with placebo (a dummy treatment). The main measures of effectiveness were based on the amount of time the patients spent awake after they had first fallen asleep and improvements in the quality of sleep over the first four to 12 weeks of treatment. A fifth study involving 283 adults compared Sliwens with lormetazepam (another medicine used to treat insomnia) looked at how sleepy the patients were the morning after taking Sliwens.

How far into the evaluation was the application when it was withdrawn?

The application was withdrawn at 'day 180'. This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions. After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.

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 Sliwens could not have been approved.

The CHMP considered the effect of Sliwens on sleep to be small. There was also a lack of information comparing the long-term use of Sliwens with placebo. The Committee was also concerned about the risk of diverticulitis (inflammation in little sacs or pouches in the intestines) in patients taking the medicine.

What were the reasons given by the company for withdrawing the application?

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

What are the consequences for patients in clinical trials or compassionate use programmes?

The company informed the CHMP that there were no consequences for patients in clinical trials or compassionate use, since all ongoing clinical trials have been discontinued.

Questions and answers on withdrawal of marketing authorisation application for Sliwens (eplivanserin)

Reference Number: EMA/23705/2010

Key facts

• Name of medicine:
  Sliwens
• Therapeutic area (MeSH):
  Sleep Initiation and Maintenance Disorders
• EMA product number:
  EMEA/H/C/001102
• Marketing authorisation applicant:
  Sanofi Aventis
• Withdrawal of application:
  18/12/2009

All documents

Withdrawal assessment report for Sliwens

Adopted Reference Number: EMA/CHMP/90435/2010

Withdrawal letter : Sliwens