Ibuprofen/Diphenhydramine Hydrochloride Wyeth: Withdrawal of the marketing authorisation application

Ibuprofen/Diphenhydramine Hydrochloride Wyeth is a medicine that contains the active substances ibuprofen and diphenhydramine hydrochloride. It was to be available as capsules.

Ibuprofen/Diphenhydramine Hydrochloride Wyeth was expected to be used for the short-term treatment of mild to moderate pain in adults who are having difficulty sleeping because of the pain. It was expected to be used without prescription.

Ibuprofen/Diphenhydramine Hydrochloride Wyeth contains two active substances that have been available in the European Union for many years in commonly used non-prescription medicines.
Ibuprofen is a painkiller that belongs to the class non-steroidal anti-inflammatory drugs (NSAIDs). It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation and pain. Ibuprofen is found in medicines used to treat pain, inflammation and fever.

Diphenhydramine hydrochloride is an antihistamine. Its main action is to block receptors for histamine, which is involved in inflammation and allergic reactions, but it also leads to drowsiness which helps to improve sleep. Diphenhydramine hydrochloride is found in medicines used to treat allergies, cough and sleep problems.

When taken together, the two active substances were expected to provide benefits for patients with pain who have difficulty sleeping because of the pain.

The effects of Ibuprofen/Diphenhydramine Hydrochloride Wyeth were first tested in experimental models before being studied in humans. The company presented the results of three main studies involving around 900 adults with pain. The studies compared the medicine with placebo (a dummy treatment) and a medicine containing ibuprofen alone. The main measures of effectiveness were based on the level of pain relief after two hours, the number of patients who were asleep after one hour and how long the patients slept.

The application was withdrawn at 'day 180'.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.

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 Ibuprofen/Diphenhydramine Hydrochloride Wyeth could not have been approved.

The CHMP noted that the applicant had not shown enough evidence that there was a relevant advantage of using Ibuprofen/Diphenhydramine Hydrochloride Wyeth over using ibuprofen alone. The main studies involved relatively young patients and therefore no conclusion could be drawn on how the medicine would work in other age groups. There was also insufficient information on the safety of the medicine compared with medicines containing only one of the active substances. Because Ibuprofen/Diphenhydramine Hydrochloride Wyeth was intended to be available without a prescription, the Committee requested more information on how it would interact with other medicines.

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

The company informed the CHMP that at present there are no ongoing clinical trials or compassionate use programmes with Ibuprofen/Diphenhydramine Hydrochloride Wyeth.