Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication LIMITED POPULATION: ARIKAYCE ® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. FDA label
Also known as Amikacin (BAY41-6551), Amikacin inhalation solution (BAY41-6551)
Amikacin · 3 trials · 2 indications
The primary efficacy variable is Survival through the late follow-up (LFU) visit. Survival is achieved when the participant is alive through the LFU visit. No other factors are considered in the evaluation of survival.
Maximum serum amikacin concentration observed from time 0 to 12 h
Time that Cmax occurred
Area under the serum amikacin concentration vs time curve from time 0 to 12 h
Amount of amikacin excreted in urine from 0 to 12 h after dosing
Amount of amikacin excreted in urine from 12 to 24 h after dosing
Amount of amikacin excreted in urine from 0 to 24 h after dosing
| Arm | Type | Description |
|---|---|---|
| Amikacin inhale (BAY41-6551) | EXPERIMENTAL | Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10. |
| Placebo | PLACEBO_COMPARATOR | Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10. |
| Amikacin inhalation solution | EXPERIMENTAL | Subjects received 125 mg/mL of aerosolized amikacin via the PDDS clinical device at a nominal dose of 400 mg every 12 h for 7-14 days |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Amikacin Inhalation Solution (BAY41-6551) | DRUG | 400 mg of aerosolized amikacin every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical) |
| Aerosolized Placebo | DRUG | Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical) |
| Amikacin (BAY41-6551) | DRUG | Single daily dose of 400 mg aerosolized amikacin and a single dose of aerosolized placebo on a rotating every 12hr schedule |
| Placebo | DRUG | Two aerosol treatments per day (one treatment every 12hr) |
Inclusion Criteria: * Males and non-pregnant, non-lactating females, 18 years of age or older * Intubated and mechanically-ventilated * Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph * Presence of Gram-negative organism(s) by either Gram stain o...
Amikacin (BAY41-6551) is an inhaled antibiotic developed as adjunctive therapy for Gram-negative bacterial pneumonia, including nosocomial pneumonia in intubated and mechanically ventilated patients. It is given directly to the lungs as an aerosol alongside standard treatment. It is investigational and has not been approved for these uses.
Nektar Therapeutics, which trades on the Nasdaq under the ticker NKTR, is developing amikacin (BAY41-6551) as an inhaled antibiotic for bacterial pneumonia. The program uses an investigational aerosol delivery approach to administer the drug directly to the lungs of patients with Gram-negative pneumonia.
Amikacin (BAY41-6551) has completed a Phase 3 trial and two Phase 2 trials, and it remains an investigational therapy rather than an approved product. The Phase 3 study, NCT01799993, enrolled 725 patients and has been completed, while the two Phase 2 studies have also finished.
Three registered trials have studied amikacin (BAY41-6551). NCT01799993 was a Phase 3 trial of inhaled amikacin as adjunctive therapy in Gram-negative pneumonia, enrolling 725 patients across multiple countries. NCT01021436 and NCT01004445 were Phase 2 studies in ventilated patients with pneumonia, enrolling 30 and 69 patients respectively. All three are completed.
Yes. Amikacin, amikacin (BAY41-6551), and amikacin inhalation solution (BAY41-6551) refer to the same investigational product. BAY41-6551 is the development code for the inhaled formulation of amikacin that Nektar Therapeutics is studying in bacterial pneumonia, delivered as an aerosol directly to the lungs.
The trials of amikacin (BAY41-6551) were randomized, double-blind, and placebo-controlled, enrolling adults 18 years and older with pneumonia. The Phase 3 trial NCT01799993 enrolled 725 patients in countries including the United States, Brazil, Canada, Mexico, South Korea, Taiwan, Thailand, and Turkey, and the Phase 2 studies enrolled 30 and 69 patients.