Higher-dose naloxone nasal spray approved
The FDA has approved Kloxxado (naloxone hydrochloride) nasal spray for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Kloxxado is an opioid antagonist that delivers 8 mg of naloxone per spray into the nasal cavity. The FDA previously approved 2 mg and 4 mg naloxone spray products.
Kloxxado is intended for immediate administration as emergency therapy in settings where opioids may be present. It can be administered by individuals with or without medical training to help reduce opioid overdose deaths.
Kloxxado is a product of Hikma Pharmaceuticals and is expected to be available in the second half of 2021.
Expanded CKD indication approved for dapagliflozin
The FDA approved an expanded indication for AstraZeneca's Farxiga (dapagliflozin) for chronic kidney disease (CKD). Originally approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, Farxiga is now approved to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with CKD at risk for progression.
Farxiga is not indicated for patients on dialysis or patients with type 1 diabetes mellitus. In addition, it was not studied, nor is it expected to be effective, in treating CKD among patients with polycystic kidney disease or among patients who require or have recently used immunosuppressive therapy to treat kidney disease.
The FDA suggests considering a lower dose of insulin or insulin secretagogue for patients with diabetes who are taking Farxiga to reduce the risk of hypoglycemia. Patients with diabetes have also experienced serious, life-threatening cases of Fournier's gangrene while on Farxiga. Other risks for all patients include dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis or ketoacidosis. Patients' volume status and kidney function should be assessed before starting on Farxiga.
Single-dose option for iron replacement therapy approved
Injectafer (ferric carboxymaltose injection) has been approved by the FDA to include a new single-dosage regimen for the treatment of iron deficiency anemia in adults who have intolerance or insufficient response to oral iron or have non-dialysis-dependent CKD.
For patients weighing at least 50 kg (110 lb), Injectafer may now be administered as a single-dose treatment course of 15 mg/kg body weight up to a maximum of 1,000 mg I.V. The new dosing option is in addition to the approved dosage of 750 mg I.V. in 2 doses separated by at least 7 days in patients weighing at least 50 kg (110 lb), for a total cumulative dose of 1,500 mg. For patients weighing less than 50 kg (110 lb), the recommended dosage is 15 mg/kg body weight I.V. in 2 doses separated by at least 7 days per course.
Injectafer is a product of American Regent, Inc.
Scabies treatment approved for adults and children
ParaPRO's Natroba (spinosad) topical suspension, 0.9%, is now approved as a topical treatment for scabies infestation in adult and pediatric patients 4 years of age and older. Natroba was originally approved in 2011 as a topical treatment of head lice infestations.
Clinical trials of Natroba in 533 patients (206 households) in which the youngest household member 4 years of age and older had an active scabies infestation found that a single application of Natroba on day 1, evaluated on day 28, was highly effective and well tolerated by patients as young as 4 years of age.