Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Liposomal amikacin for using the PARI Investigational eFlow Nebulizer · 1 trial · 1 indication
Relative Change (%) from baseline to end of study (Day 168) in FEV1 (1 second)
| Arm | Type | Description |
|---|---|---|
| Arikayce™ | EXPERIMENTAL | Arikayce™ is liposomal amikacin for inhalation |
| TOBI® | ACTIVE_COMPARATOR | TOBI® is tobramycin inhalation solution |
| Name | Type | Description |
|---|---|---|
| Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer. | DRUG | Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization. * 590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer. * Administration time is approximately 13 minutes. * liposomal amikacin for inhalation will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment. |
| Tobramycin inhalation solution using a PARI LC® Plus nebulizer. | DRUG | 300 mg tobramycin inhalation solution is administered twice a day using a PARI LC® Plus nebulizer. * Nebulization time is approximately 20 minutes for each administration. * Tobramycin inhalation solution will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment |
Key Inclusion Criteria: * Written informed consent or assent * Confirmed diagnosis of CF * History of chronic infection with Pseudomonas aeruginosa * Sputum culture positive for Pseudomonas aeruginosa at Screening * FEV1 ≥ 25% of predicted value at Screening Key Exclusion Criteria: * FEV1 \<25% o...
Liposomal amikacin for inhalation, also known as Arikayce, is being developed for the treatment of Pseudomonas aeruginosa infection. It is an inhaled formulation of the antibiotic amikacin that delivers the drug directly to the lungs. Insmed Incorporated is developing the therapy for patients with chronic Pseudomonas aeruginosa infections.
Liposomal amikacin for inhalation, also known as Arikayce, is being developed by Insmed Incorporated, which trades under the ticker INSM. Insmed is the sponsor of the clinical program evaluating this inhaled antibiotic formulation for Pseudomonas aeruginosa infection.
Liposomal amikacin for inhalation, also known as Arikayce, is in Phase 3 clinical development. The Phase 3 trial evaluating the therapy has been completed. It is an investigational product and is not approved for the treatment of Pseudomonas aeruginosa infection.
The Phase 3 trial of liposomal amikacin for inhalation, also known as Arikayce, is registered as NCT01315678. Titled Study to Evaluate Arikayce in CF Patients With Chronic Pseudomonas Aeruginosa Infections, it enrolled 302 participants and has been completed. It was an active-controlled, randomized study conducted across multiple countries in Europe and Canada.
Yes. Liposomal amikacin for inhalation and Arikayce refer to the same investigational product. Arikayce is the brand name used for the liposomal amikacin formulation delivered via the PARI Investigational eFlow Nebulizer. Both names describe the same therapy being developed by Insmed Incorporated for Pseudomonas aeruginosa infection.
Liposomal amikacin for inhalation, also known as Arikayce, is administered using the PARI Investigational eFlow Nebulizer. This delivery approach is designed to deposit the liposomal antibiotic formulation directly into the lungs. The Phase 3 trial NCT01315678 evaluated this inhaled therapy in patients with chronic Pseudomonas aeruginosa infections.