The recent wave of drug shortages adds to the already long list of medications not otherwise available for use, either due to manufacturing short supply or permanent discontinuation resulting from diminished profitability. As a result, patients, caregivers, and healthcare providers are anxiously exploring alternatives to essential medications.
One medication, epinephrine injection (sold as EpiPen Auto-Injector), has been on that list of shortages and recently came under government scrutiny for monopolization and abuse of the medication-distribution system. In order to provide greater transparency and to confirm that these products remain available, the FDA released a public notice on May 9, 2018, addressing the intermittent supply constraints of EpiPen (epinephrine injection, USP) 0.3 mg and EpiPen Jr (epinephrine injection, USP) 0.15-mg Auto-Injectors, and the authorized generic versions of these products.
Mylan responded with a press release indicating that they had informed the FDA of supply constraints due to manufacturing delays from Pfizer, and they further noted that Mylan and Pfizer have remained in close contact with the FDA to provide regular updates on the inventory status.
In addition to adding to the potential source pool of epinephrine, this new product in the development pipeline is formulated to provide a timely and appropriate dose of epinephrine that does not require injection via needle to prevent anaphylaxis and potentially fatal outcomes. While needle delivery is effective, the invasive, potentially painful administration of an injection can be intimidating and may provoke unnecessary anxiety in needle-phobic or -avoidant patients.
Dr. David Fleischer, associate professor at the University of Colorado School of Medicine, served as an advisory board physician and was quoted in a recent press release updating the public on the progress of this medication. “Because epinephrine is the first-line treatment for anaphylaxis, having other effective delivery options, such as a needleless alternative, may be attractive to patients and healthcare providers, as well as parents, school nurses, first responders and emergency department staff,” he said.
“If the results of the initial study are borne out in a subsequent trial, this epinephrine nasal spray may become a viable alternative for patients with food allergy, venom allergy or other causes of anaphylaxis who must be prepared to treat it rapidly and effectively when it occurs,” said Dr. Fleischer.
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