Results With ENDARI
The efficacy and safety of ENDARI in sickle cell disease was evaluated in a clinical study.
The study included 230 patients with sickle cell anemia or sickle β0-thalassemia.
Patients were treated with ENDARI or placebo for 48 weeks.
All enrolled patients had 2 or more painful crises within 12 months prior to enrollment.
ENDARI was shown to lower the frequency of sickle cell crises by 25%
ENDARI: A median number of 3 sickle cell
crises per patient
Placebo: A median number of 4 sickle cell
crises per patient
ENDARI was shown to lower the frequency of hospitalizations by 33%
ENDARI: A median number of 2 hospitalizations for sickle cell pain
Placebo: A median number of 3 hospitalizations for sickle cell pain
ENDARI was shown to reduce cumulative days spent in the hospital by 41%
ENDARI: A median number of 6.5 cumulative days spent in the hospital
Placebo: A median number of 11 cumulative days spent in the hospital
ENDARI was shown to increase time to first sickle cell crisis by 30 days
ENDARI: A median number of 84 days until the first sickle cell crisis
Placebo: A median number of 54 days until the first sickle cell crisis
ENDARI was shown to reduce the occurrence of acute chest syndrome
ENDARI: 13 out of 152 patients (8.6%) experienced acute chest syndrome
Placebo: 18 out of 78 (23.1%) patients experienced acute chest syndrome
N = 187
N = 111
|Abdominal Pain 1||17||16|
|Pain inn extremity||13||7|
|1 Abdominal pain = abdominal pain and abdominal pain, upper|
ENDARI [L-glutamine oral powder] is indicated to reduce the acute complications of sickle cell disease in adults and children 5 years and older.
IMPORTANT SAFETY INFORMATION
The most common side effects in clinical studies were constipation, nausea, headache, pain in the stomach area, cough, pain in the hands or feet, back pain, and chest pain.
Side effects that led to a stop in treatment during the clinical studies were 1 case each of overactive spleen (an organ that helps filter your blood), pain in the stomach area, indigestion, burning sensation and hot flash.
It is not known whether ENDARI is safe and effective in children younger than 5 years old with sickle cell disease.
Please see full Prescribing Information.
You are encouraged to report all possible negative side effects of ENDARI to Emmaus Medical, Inc. at 1-877-420-6493 or FDA at 1-800-FDA-1080 or www.fda.gov/medwatch.