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Intranasal Fentanyl · 1 trial · 2 indications
During the efficacy phase participants assessed their pain intensity at each breakthrough pain (BTP) episode at 0 and 10 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is "worst possible pain". PID10 is calculated as the difference in pain intensity from time 0 to 10 minutes. A positive value is a decrease (improvement) of the pain; a ≥ 2-point difference is considered as clinically important.
| Arm | Type | Description |
|---|---|---|
| Intranasal Fentanyl Spray (INFS) | EXPERIMENTAL | All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Intranasal Fentanyl Spray (INFS) | DRUG | Applied as 1 puff (= 1 dose) in one nostril, or applied as two puffs (= 2 doses, 1 in each nostril) with ten minutes apart. |
| Placebo | DRUG | Matching intranasal placebo spray |
Inclusion Criteria: All inclusion criteria were answered 'yes' for a patient to participate in the clinical trial. * Is the patient a cancer patient with breakthrough Pain (BTP)? * Has the patient received either oral opioids or transdermal fentanyl for treatment of background pain (BGP) within th...
Intranasal Fentanyl is used for the management of breakthrough pain in cancer patients. Breakthrough pain is a transient flare of pain that occurs despite otherwise controlled background pain. It is administered through the nasal route for rapid absorption and quick onset of analgesic effect.
Intranasal Fentanyl is being developed by Takeda Pharmaceutical Company Limited, which is listed on the stock exchange under the ticker symbol TAK. Takeda is a global biopharmaceutical company focused on various therapeutic areas, including oncology.
Intranasal Fentanyl is in Phase 3 of clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions.
Intranasal Fentanyl has one completed Phase 3 clinical trial with the identifier NCT01429051. The trial was titled 'A Clinical Trial With Intranasal Fentanyl in Cancer Patients With Breakthrough Pain' and enrolled 46 participants in Hungary, Norway, and Russia. The study was double-blind but uncontrolled.
Intranasal Fentanyl is a specific formulation of fentanyl, an opioid analgesic, delivered via the nasal route. While other fentanyl products exist, such as transdermal patches or lozenges, this drug is unique in its intranasal delivery method, which allows for rapid absorption and quick pain relief.