Numient - Levodopa / Carbidopa

What is Numient and what is Levodopa / Carbidopa used for?

Numient is indicated for the treatment of symptoms of Parkinson's disease, a progressive mental disorder that causes tremor, slowness of movement and muscle stiffness. Contains the active ingredients levodopa and carbidopa.

How is Numient - Levodopa / Carbidopa used?

Numient is available as capsules to be taken by mouth. The starting dose for patients who have never taken levodopa before is one capsule containing 95 mg of levodopa and 23.75 mg of carbidopa, three times a day for the first three days. The doctor may then increase the dose depending on the patient's response to treatment. In patients who are already taking levodopa, the doctor determines the Numient dose based on the ongoing therapy.

Numient in capsules is taken with a glass of water, with or without food, but not simultaneously with high-protein meals, which can reduce the absorption of the medicine.

Patients who have difficulty swallowing the capsule can spread the contents on soft foods such as apple purée, yogurt or pudding. The food should therefore be ingested immediately, without chewing.

Numient can only be obtained with a prescription and is available in the following dosages: 95 mg / 23.75 mg, 145 mg / 36.25 mg, 195 mg / 48.75 mg and 245 mg / 61.25 mg. For more information on the use of Numient, see the summary of product characteristics (also part of the EPAR).

How does Numient - Levodopa / Carbidopa work?

In patients with Parkinson's disease, the brain cells that produce dopamine, an important neurotransmitter in movement control, begin to die and the amount of dopamine in the brain decreases.

Numient contains levodopa, which turns into dopamine in the brain, helping to restore dopamine levels. The carbidopa substance present in Numient prevents levodopa from turning into dopamine in the general bloodstream, ie before reaching the brain. The combination of levodopa and carbidopa is used in other medicines used to treat Parkinson's disease.

In Numient a part of the active ingredients is released immediately, while the remainder is released by degrees, allowing for more stable levels of levodopa. Capsules of this kind are known as modified release capsules.

What benefit has Numient - Levodopa / Carbidopa shown during the studies?

In a study of 381 patients with early-stage Parkinson's disease, Numient administered at various doses was more effective in improving symptoms than placebo (a dummy treatment). After 30 weeks, an average improvement of 11.7 to 14.9 points (depending on the dose) on a standard symptom scale (UPDRS, Unified Parkinson's Disease Rating Scale, Part II and part III). In subjects treated with placebo the average improvement was 0.6 points.

A second study compared Numient with another treatment based on levodopa and carbidopa in 393 patients with advanced Parkinson's disease. The study examined the extent to which treatments helped reduce the so-called "off" periods, in which patients have more difficulty walking. After 13 weeks, patients treated with Numient reported "off" periods equal to 24% of waking hours compared to 30% of waking hours reported by patients treated with the comparator medicine. In both groups the "off" phase at the beginning of the study corresponded to 36-37% of the waking hours.

What is the risk associated with Numient - Levodopa / Carbidopa?

The most common side effects of Numient are nausea (affecting 12% of patients), dizziness, headache and involuntary movements (each observed in 8% of patients) and insomnia (6% of patients). More serious side effects, of uncommon frequency, include haemorrhage in the intestine and allergic reactions.

Numient should not be used in patients with narrow-angle glaucoma (an eye disorder) or pheochromocytoma (a tumor affecting the adrenal glands). Nor should it be used in patients taking medicines known as non-selective monoamine oxidase inhibitors (MAOIs) or in patients who have suffered from certain conditions in the past. For the full list of side effects and limitations, see the package leaflet.

Why has Numient - Levodopa / Carbidopa been approved?

Studies show that Numient is effective in reducing symptoms in patients with early and advanced Parkinson's disease. Another benefit concerns the formulation of the active ingredients in Numient, which promotes the maintenance of more stable levodopa levels.

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Numient's benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Numient - Levodopa / Carbidopa?

A risk management plan has been developed to ensure that Numient is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Numient, including the appropriate precautions to be followed by healthcare professionals and patients.