What is Zalviso - Sufentanil and what is it used for?
Zalviso is an opioid (a powerful pain reliever) indicated for pain management after surgery. Contains the active substance sufentanil. Zalviso is a 'hybrid' medicine.
This means that Zalviso is similar to a 'reference medicine' which contains the same active substance, 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 in the form of sublingual tablets (tablets to dissolve under the tongue).
How is Zalviso 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 prescription from physicians experienced in the treatment of patients with opioids.
The patient places 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 that only the patient who you have received a special adhesive label to be applied 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 that has been used for pain control for many years. 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. This way the medicine is transported to receptors in the brain and spinal cord, where sufentanil works to relieve pain.
What benefit has Zalviso - Sufentanil shown during the studies?
As this is a generic hybrid, in addition to the results of the studies carried out on its own, the applicant submitted data relating to the reference drugs.
One main study involved 178 patients undergoing abdominal surgery, while a second study involved 426 patients undergoing knee or hip surgery. In both cases, Zalviso was compared with a placebo (a dummy treatment). The main measure of effectiveness was patients' scores to measure pain intensity over 48 hours of treatment. For abdominal surgery, pain intensity decreased by an average of 50 points more with Zalviso versus placebo (106 versus 56 points). For knee and hip surgery, pain intensity decreased by approximately 88 points more with Zalviso than placebo (76 versus -11 points).
A third main study compared Zalviso with a patient-controlled pain relief system using morphine, another opioid; the study involved 359 patients who had undergone major surgery on the abdomen, knee or hip. Of the 177 patients treated with Zalviso, 139 (79%) rated the pain control system as excellent or good compared to 118 of 180 patients (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 (difficulty breathing), which could also lead to a total impairment of breathing in the patient. Zalviso must not be used in patients who already have severe respiratory failure.
For the full list of side effects and limitations of 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. Additional option for patient-controlled pain relief immediately after surgery, i.e. when pain is particularly severe, especially considering the fact that administration is not via intravenous injection. As for safety, side effects are common with opioids and were considered manageable. However, taking into account that post-operative pain spontaneously improves over time, as well as the body's potential for dependence or addiction to the opioid substance, which requires higher doses, the medicine and related administration device should only be used in a hospital setting and for a maximum period or 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 added to the summary of product characteristics and package leaflet for Zalviso, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about Zalviso - Sufentanil
For more information about Zalviso therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The information on Zalviso - Sufentanil published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
