Bryn Pharma has entered into an agreement with Aptar Pharma for the supply and worldwide exclusive right to use Aptar's novel, FDA-approved Bidose (BDS) nasal device for the delivery of epinephrine to treat anaphylaxis.
Up to 30 percent of patients who develop anaphylaxis will require a second dose of epinephrine to control symptoms. Current practice parameters recommend that physicians prescribe two epinephrine auto-injectors to be carried by their patients at all times.
Bryn completed dosing in its pivotal clinical trial of its Epinephrine Nasal Spray (BRYN-NDS1C), using a single, portable, optimized Aptar BDS device capable of delivering two therapeutic doses of epinephrine, replacing the need to carry two epinephrine auto-injectors.
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"Studies have shown that the majority of people at risk for anaphylaxis do not carry two epinephrine auto-injectors with them at all times, putting them at greater risk of severe complications during an allergic reaction," said David Dworaczyk, Ph.D., CEO of Bryn Pharma. "We are excited to partner with Aptar Pharma to develop a product that can provide patients with a life-saving treatment that fits in a pocket, is easy to use and complies with practice parameters."
Anaphylaxis is a serious, life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medication and latex. A major difference between anaphylaxis and other allergic reactions is that anaphylaxis typically involves more than one system of the body. Anaphylaxis requires immediate medical treatment, driving approximately 100,000 emergency room visits in the U.S. each year. Because 30 percent of patients who develop anaphylaxis will require a second dose of epinephrine to control symptoms, practice parameters recommend that physicians provide patients with two auto-injectors.4 If not treated properly, anaphylaxis can be fatal.