Zalviso - Sufentanil

What is Zalviso - Sufentanil used for?

Zalviso is an opioid (a powerful pain reliever) indicated for pain management after surgery. It contains the active substance sufentanil. Zalviso is a "hybrid" medicine.

This means that Zalviso is similar to a "reference medicine" that contains the same active ingredient, but in a different formula. The reference medicine for Zalviso is Sufenta Forte and is available as a solution for injection, while Zalviso is available as sublingual tablets (tablets to dissolve under the tongue).

How is Zalviso - Sufentanil used?

Zalviso is available as sublingual tablets containing 15 micrograms of sufentanil. The tablets are intended for hospital use only and can only be obtained with a doctor's prescription from doctors experienced in treating patients with opioids.

The patient positions the Zalviso tablets under the tongue, if necessary using a special device. After taking a dose, the device blocks the delivery of the second dose for 20 minutes and prevents the patient from taking more than 3 doses in an hour. The device also uses an identification system, so only the patient who has received a special adhesive label to apply to the thumb can take the tablets. The tablets dissolve under the tongue and should not be chewed or swallowed. Treatment continues for a maximum period of 72 hours.

For more information, see the package leaflet.

How does Zalviso - Sufentanil work?

The active substance in Zalviso, sufentanil, is an opioid. It is a well-known substance, used for many years for pain control. When the patient places a Zalviso tablet under the tongue, a dose of sufentanil is rapidly absorbed into the bloodstream through the blood vessels in the oral mucosa. In this way the medicine is transported to the receptors in the brain and spinal cord, where sufentanil acts to relieve pain.

What benefit has Zalviso - Sufentanil shown during the studies?

Since this is a generic hybrid, in addition to the results of the studies conducted on its own, the applicant presented data on the reference drugs.

A main study was conducted on 178 patients who underwent abdominal surgery, while a second study was carried out on 426 patients who underwent knee or hip surgery. In both cases Zalviso was compared with a placebo (a dummy treatment). The main measure of effectiveness was the score given by patients to measure pain intensity over a 48-hour treatment period. For abdominal surgery, pain intensity decreased on average by 50 points more with Zalviso than with placebo (106 versus 56 points). For knee and hip surgery, pain intensity decreased by about 88 points more with Zalviso than with placebo (76 against -11 points).

A third main study compared Zalviso with a patient-controlled pain relief system using morphine, another opioid; the study was attended by 359 patients who had undergone a major abdominal, knee or hip surgery. Of the 177 patients treated with Zalviso, 139 (79%) judged the pain control system to be excellent or good compared to 118 out of 180 (66%) who used morphine.

What is the risk associated with Zalviso - Sufentanil?

The most common side effects with Zalviso (which may affect more than 1 in 10 people) are nausea and vomiting. The most serious side effect is respiratory depression (breathing difficulty), which could also lead to total impairment of breathing in the patient. Zalviso should not be used in patients already suffering from severe respiratory failure.

For the full list of side effects and restrictions with Zalviso, see the package leaflet.

Why has Zalviso - Sufentanil been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zalviso's benefits are greater than its risks and recommended that it be approved for use in the EU. The committee considered the existence of an additional option for the relief of pain controlled by the patient immediately after a surgical operation, ie when the pain is particularly intense, especially considering the fact that the administration does not take place by intravenous injection. As for safety, the side effects are frequent with opioids and have been considered manageable. However, taking into account the fact that post-operative pain improves spontaneously over time, in addition to the addictive or addictive potential of the organism to the opioid substance, such as to require higher doses, the medicinal product and the relative administration device must be used only in a hospital environment and for a maximum period of 72 hours.

What measures are being taken to ensure the safe and effective use of Zalviso - Sufentanil?

A risk management plan has been developed to ensure that Zalviso 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 Zalviso, including the appropriate precautions to be followed by healthcare professionals and patients.