Nasal spray approved for acute treatment of migraine
The FDA approved Trudhesa (dihydroergotamine mesylate) nasal spray for the acute treatment of migraine with or without aura in adults. The medication uses a proprietary technology to deliver a lower dose (0.725 mg) of dihydroergotamine mesylate to the upper nasal space. The recommended dose is 1.45 mg administered as two metered sprays into the nose (one spray of 0.725 mg into each nostril).
In clinical trials, 66.3% of patients using Trudhesa achieved pain relief, 38% achieved pain freedom, and 52% had freedom from their most bothersome migraine symptom at 2 hours.
The drug has a boxed warning for peripheral ischemia following coadministration with strong CYP3A4 inhibitors.
Trudhesa is a product of Impel NeuroPharma, which is providing a copay savings program for eligible patients.
New cream approved for atopic dermatitis
The FDA approved Opzelura (ruxolitinib) cream for the short-term and noncontinuous chronic treatment of mild-to-moderate atopic dermatitis in nonimmunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The approval was based on data from clinical trials in over 1,200 patients with atopic dermatitis who received Opzelura cream or placebo twice daily for 8 weeks. Findings showed that 53.8% of patients treated with Opzelura achieved treatment success compared with 15.1% of those receiving placebo.
Opzelura is a Janus kinase (JAK) inhibitor; like other JAK inhibitors, its labeling carries a boxed warning concerning serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis associated with use of JAK inhibitors for inflammatory conditions.
Opzelura is a product of Incyte.
FDA approves new Gvoke formulation for severe hypoglycemia
Gvoke Kit was approved for the treatment of hypoglycemia in pediatric and adult patients with diabetes mellitus 2 years of age and older. The ready-to-use, room temperature-stable, liquid glucagon is administered into the lower abdomen, outer thigh, or outer upper arm and does not require reconstitution. Gvoke Kit will be available as a 1 mg/0.2 mL single-dose vial and syringe kit. Gvoke Kit contains one single-dose sterile syringe with markings for 0.1 mL (pediatric 0.5 mg dose) and 0.2 mL (adult 1 mg dose), and one single-dose vial containing 0.2 mL of solution. Gvoke Kit is expected to be available in the first quarter of 2022. Gvoke is a product of Xeris Pharmaceuticals.
Flu and COVID-19 vaccines can be given on the same day
Patients can receive influenza and COVID-19 vaccinations during the same visit and do not have to wait 2 weeks between COVID-19 and influenza vaccinations, as previously recommended, the CDC announced. The agency said the way the body develops an immune response to a vaccine is generally the same whether given alone or along with other vaccines, as long as the recipient is eligible for the vaccines. The same is true for possible adverse reactions to vaccines. The previous 2-week waiting period was implemented as a precaution during a period when the vaccines were new and not based on any known safety or immunogenicity concerns.
If administering other immunizations along with COVID-19 vaccines, providers should separate injection sites by at least an inch, and influenza vaccines that are more likely to cause a local reaction (for example, high-dose or adjuvanted inactivated flu vaccines) should be administered in different limbs if possible.
The American Academy of Pediatrics also recommends that influenza and COVID-19 vaccines be administered during the same visit for children age 12 years and older who are eligible for the COVID-19 vaccines.