FDA approves first noninjection treatment for severe hypoglycemia
Baqsimi nasal powder has been approved as the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. Baqsimi increases blood sugar levels by simulating the liver to release stored glucose into the bloodstream and is indicated for use in patients with diabetes age 4 years and older.
Until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a multiple-stage process. Baqsimi simplifies that process, which is critical during a severe hypoglycemic episode, especially since the patient may have lost consciousness or may be having a seizure.
In clinical trials comparing Baqsimi with a single dose of glucagon, Baqsimi was shown to effectively and safely increase blood sugar levels in both adults and children over age 4 years. Baqsimi, a product of Eli Lilly and Company, comes in a single-use dispenser.
Progestin-only contraceptive approved
The FDA approved drospirenone (Slynd) to prevent pregnancy. The progestin-only oral contraceptive lowers the risk of becoming pregnant primarily by suppressing ovulation.
Drospirenone is a product of Exeltis USA. In clinical trials, the percentage of women experiencing scheduled bleeding or unscheduled bleeding and/or spotting decreased over time. Based on subjects' diaries from the clinical trials, the overall percentage of women who experienced unscheduled bleeding at cycle 1 was 61%, which decreased to 40% by cycle 13.
Drospirenone is supplied in blister cards, each holding 24 white tablets containing drospirenone 4 mg and 4 green inert tablets.
New combo drug approved for complicated urinary tract infection and complicated intra-abdominal infections
The FDA approved imipenem, cilastatin, and relebactam (Recarbrio) injection for adults with complicated urinary tract infections and complicated intra-abdominal infections. Imipenem-cilastatin was previously approved; relebactam is a new beta-lactamase inhibitor. It is important that the use of the injection drug be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient's infection, the FDA notes.
The most common adverse reactions observed in patients treated with the injection drug included nausea, diarrhea, headache, fever, and increased liver enzymes. The injection drug should not be used in patients taking ganciclovir unless the benefits outweigh the risks, as generalized seizures have been reported. Patients should also avoid using the injection drug when taking valproic acid or divalproex sodium, as a reduction in valproic acid levels may lead to seizures.
The combo injection drug is a product of Merck & Co, Inc.
FDA approves digital maintenance asthma inhaler therapy
The FDA approved Teva's fluticasone propionate 113 mcg and salmeterol 14 mcg (AirDuo Digihaler) for the treatment of asthma in patients age 12 years and older. The product is a combination of the inhaled corticosteroid (ICS) fluticasone propionate and the long-acting beta2-adrenergic agonist (LABA) salmeterol and is indicated for patients not adequately controlled on a long-term asthma medication, such as an ICS, or whose disease warrants initiation of treatment with both an ICS and LABA.
The inhaler contains an electronic module that detects, records, and stores data on inhaler events, including peak inspiratory flow rate, for transmission to a companion mobile app where inhaler events are categorized. The app allows patients to review and share data with their healthcare providers and schedule dosing reminders. Use of the app is not required for administration of the inhaler.
The inhaler is supplied in three strengths: 55 mcg fluticasone propionate/14 mcg salmeterol, 113 mcg fluticasone propionate/14 mcg salmeterol, and 232 mcg fluticasone propionate/14 mcg salmeterol.