Baqsimi is a ready-to-use nasal powder that delivers 3mg of glucagon in a single-use intranasal dispenser. Patients administer the dose by inserting the tip into one nostril and pressing the device plunger all the way in until the green line on the device is no longer showing; the dose does not need to be inhaled. If there is no response after 15 minutes, an additional 3mg dose from a new device may be administered.
The approval was based on several studies in adult and pediatric patients which compared a 3mg dose of Baqsimi to a 1mg dose of intramuscular glucagon. Results showed that the intranasal product was noninferior to the injectable glucagon in reversing insulin-induced hypoglycemia. Additionally, a phase 1 study determined that the absorption of Baqsimi was not impaired by nasal congestion resulting from the common cold with or without the use of decongestants.
Regarding safety, the most common treatment emergent adverse events were nausea, vomiting, headache, upper respiratory tract irritation (ie, rhinorrhea, nasal discomfort, nasal congestion, cough, and epistaxis), watery eyes, redness of eyes, itchy nose, throat and eyes.
“There are many products on the market for those who need insulin, but 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 several-step process,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure.”
Baqsimi is expected to be available in retail pharmacies within 1 month. It will be supplied as an intranasal device containing a 3mg dose of glucagon in 1 or 2 packs. Each device contains 1 dose of glucagon and cannot be reused.
For more information visit baqsimi.com.
This article originally appeared on MPR