Instanyl - fentanyl

What is Instanyl?

Instanyl is a nasal spray containing the active substance fentanyl (50, 100 and 200 micrograms per dose).

What is Instanyl used for?

Instanyl is indicated for the treatment of "breakthrough pain" in cancer patients already on opioid therapy (a class of painkillers that includes morphine and fentanyl) to control chronic cancer pain. By "intense episodic pain" we mean those painful episodes that suddenly appear in addition to the pain already treated with painkillers.

The medicine can only be obtained with a prescription.

How is Instanyl used?

Treatment with Instanyl should be started and maintained under the supervision of a doctor experienced in the management of opioid treatment in cancer patients. The doctor must keep in mind the potential for abuse of Instanyl.

Before starting treatment with Instanyl, chronic pain should be effectively controlled by opioid against pain and the patient should have no more than four episodic intense pain attacks per day.

The first dose of Instanyl is 50 micrograms (a nebulization in one nostril); the dose is progressively increased to reach the dose that ensures a sufficient improvement of the painful symptom. If the improvement obtained is not satisfactory, it is possible to administer the same dose again at a distance of not less than 10 minutes.

Instanyl can be administered for up to four episodic intense pain attacks per

day. For more details, see the package leaflet.

How does Instanyl work?

The active substance in Instanyl, fentanyl, is a well-known opioid used for many years in pain therapy. In the medicine Instanyl, fentanyl is in the form of a nasal spray. By inhaling Instanyl, a dose of fentanyl is absorbed into the bloodstream through the respiratory tract. Once in the bloodstream, fentanyl acts on brain and spinal cord receptors to prevent pain.

How has Instanyl been studied?

Since fentanyl has been used for many years, the company presented data taken from scientific literature and studies conducted by the company itself. In one main study 178 adult patients with cancer and breakthrough pain inhaled a dose of Instanyl (50, 100 or 200 micrograms) or a placebo (a dummy treatment) during episodic intense pain attacks. In another main study, 128 patients took increasing doses of Instanyl until they reached a dose sufficient to improve the painful symptom. The maximum dose of 200 micrograms was administered by single inhalation into a nostril; patients could proceed with a second administration after 10 minutes if the first had not produced a satisfactory improvement in pain. Each patient subsequently employed the identified dose of Instanyl or placebo in episodic intense pain attacks. The main efficacy parameters in the two studies were the change in pain intensity, measured by a pain scale, and the number of patients who responded to treatment after 10 minutes. Each patient expressed an assessment of pain intensity using an 11-point scale. Treatment response was defined as a reduction of at least two points in the intensity of breakthrough pain. A third study of 139 patients compared Instanyl and fentanyl as a "transmucosal" tablet (ie absorbed through the oral mucosa). The main efficacy parameter was the rate of pain improvement after an attack of breakthrough pain. Patients taking Instanyl could take a second inhalation 10 minutes after the first in case of insufficient improvement in pain.

What benefit has Instanyl shown during the studies?

Instanyl was more effective than placebo in the treatment of breakthrough pain in cancer patients. In one of the main studies the change in pain intensity after 10 minutes was between 1.8 and 2.7 points of pain for patients treated with Instanyl compared to 1.4 points for patients treated with placebo. The number of patients who responded to treatment was also higher for Instanyl than for placebo.

In the second main study the change in pain intensity after 10 minutes was 2.0-2.7 points after treatment with Instanyl compared to 1.3 points after placebo treatment. The number of episodic intense pain attacks that responded to treatment was also greater in patients treated with Instanyl than in those treated with placebo.

In the third study, patients treated with Instanyl achieved faster pain improvement than patients treated with the comparator.

What is the risk associated with Instanyl?

The most common side effects associated with Instanyl (seen in between 1 and 10 patients in 100) are drowsiness, dizziness, headache, dizziness, redness, flushing, throat irritation, nausea, vomiting and hyperhidrosis (excessive sweating). For the full list of all side effects reported with Instanyl, see the Package Leaflet.

Instanyl should not be used in patients who may be hypersensitive (allergic) to fentanyl or any of the other ingredients. It should not be used in patients who do not already follow opioid treatment for pain control or in patients with severe respiratory depression or severe pulmonary obstruction (diseases that severely prevent breathing).

Instanyl should also not be used in patients undergoing radiation therapy (treatment with radiation) or subject to recurrent episodes of epistaxis (bleeding from the nose).

Why has Instanyl been approved?

The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Instanyl outweigh its risks in the management of breakthrough pain in adults already in opioid maintenance treatment against chronic cancer pain and recommended that authorization be granted marketing for Instanyl.

What measures are being taken to ensure the safe use of Instanyl?

The company that produces Instanyl is committed to providing information materials in all Member States and intended for patients, doctors and pharmacists to illustrate the correct and safe use of the medicine.