Axura - memantine hydrochloride

What is Axura?

Axura is a medicine that contains the active substance memantine hydrochloride, available as oblong tablets (white: 5 mg and 10 mg; orange: 15 mg; red: 20 mg). 10 mg tablets have a break line that allows them to be easily divided into two. Axura is also available as an oral solution, to be administered with a pump that releases 5 mg of memantine hydrochloride whenever it is operated.

What is Axura used for?

Axura is used in the treatment of patients with moderate to severe Alzheimer's disease. Alzheimer's disease is a type of dementia (a mental disorder) that gradually affects memory, intellectual capacity and behavior. The medicine can only be obtained with a prescription.

How is Axura used?

Treatment should be started and supervised by a doctor experienced in the diagnosis and treatment of Alzheimer's disease. Therapy should only be started if caregivers are available who regularly monitor the use of Axura by the patient. Axura should be given once a day, with or without food, at about the same time each day. To reduce the risk of side effects, the dose of Axura is gradually increased over the first three weeks of treatment: the dose is 5 mg for the first week; 10 mg for the second week and 15 mg for the third week. From the fourth week onwards, the recommended maintenance dose is 20 mg once a day. In patients with moderate or severe kidney problems it may be necessary to reduce the dose. If the solution is used, the dose should first be poured into a spoon or a glass of water and not directly into the mouth. For more information, see the package leaflet.

How does Axura work?

The active substance in Axura, memantine hydrochloride, is an antidementia medicine. The cause of Alzheimer's disease is not known, however it is believed that memory loss during the course of the disease is due to a disturbance in the transmission of messages in the brain.

Axura works by blocking particular types of receptor, called NMDA receptors, which are normally used

binds glutamate, a neurotransmitter. Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with each other. Alterations in the way that glutamate transmits signals within the brain have been linked to the memory loss observed in Alzheimer's disease. Furthermore, an over-stimulation of NMDA receptors can cause damage or cell death. By blocking NMDA receptors, memantine hydrochloride improves signal transmission in the brain and reduces the symptoms of Alzheimer's disease.

How has Axura been studied?

Axura has been studied in three main studies involving a total of 1 125 patients with Alzheimer's disease, some of whom had taken other drugs to control the disease in the past.

The first study was conducted on 252 patients with moderately severe to severe disease, while the other two studies were conducted on a total of 873 subjects with a mild to moderate form. Axura was compared with placebo (a dummy treatment) over a period of 24 to 28 weeks. The main indicators of effectiveness were the change in symptoms in three main areas: functional (the degree of disability), cognitive (the ability to think, learn and remember) and global (a combination of different areas including general functioning, cognitive symptoms, behavior and ability to perform daily activities).

Axura was also analyzed in three additional studies conducted on a total of 1 186 patients suffering from the disease in mild to severe form.

What benefit has Axura shown during the studies?

Axura was more effective than placebo in controlling the symptoms of Alzheimer's disease. In the study concerning the moderately severe to severe form of the disease, after 28 weeks of treatment, patients who had taken Axura reported fewer symptoms (measured on the basis of both global and functional scores) than those on placebo. Regarding the two studies conducted on the mild and moderate form of the disease, after 24 weeks of treatment, patients treated with Axura reported less severe symptoms, measured on the basis of global and cognitive scores. However, when these results were analyzed in combination with those of the three additional studies, it was noted that the effect of Axura was more attenuated in patients suffering from the mild form of the disease.

What is the risk associated with Axura?

The most common side effects with Axura (seen in between 1 and 10 patients in 100) are drowsiness, dizziness, high blood pressure (increased blood pressure), dyspnoea (difficulty breathing), constipation and headache. For the full list of all side effects reported with Axura, see the Package Leaflet.

Axura should not be used in people who may be hypersensitive (allergic) to memantine hydrochloride or any other substance.

Why has Axura been approved?

The Committee for Medicinal Products for Human Use (CHMP) has determined that Axura's benefits are greater than its risks for the treatment of patients with moderate to severe Alzheimer's disease and has therefore recommended that they be given marketing authorization. .