Bryn Pharma issued a press release (see below) earlier today announcing the completion of their study of UTULYTM, the brand name for their nasal epinephrine candidate formerly known as BRYN-NDS1C.
The primary objective of the study was to compare the candidate’s pharmacokinetics (how it disperses through the body) and pharmacodynamics (how the body reacts to the drug) with epinephrine auto-injectors.
Epinephrine is the only drug that can halt and reverse the progression of anaphylaxis, a serious life-threatening reaction to a food, drug, insect venom, or environmental substance. Prompt administration of epinephrine is imperative when anaphylaxis is suspected.
Today, consumers must choose from a small number of devices that all use a needle to inject epinephrine via the outer thigh. Aside from the cost of such devices, some will delay administration of the drug in an emergency due to “fear of the jab”. Delaying the administration of epinephrine with anaphylaxis can have dire consequences.
Approval of a nasal epinephrine alternative would increase supply, lower costs, and conceivably lessen the time to administration for those — especially young children — who fear needles.
Bryn Pharma Announces Completion of its Pivotal Study Comparing UTULYTM Epinephrine Intranasal Spray vs. 0.3 mg Epinephrine Autoinjector for the Treatment of Anaphylaxis
Bryn also announces completion of its human factor program and congestion study
Raleigh, NC – September 13, 2022 – Bryn Pharma LLC, a privately held pharmaceutical company dedicated to finding a better way for patients and caregivers to treat anaphylaxis, announced today the completion of its pivotal study of UTULY (epinephrine nasal spray). The primary objective of the study was to evaluate whether the administration of UTULY could achieve a successful release profile with both short- and long-term pharmacokinetic (PK) and pharmacodynamic (PD) outcomes comparable to those seen with administration of the 0.3 mg epinephrine autoinjector (EpiPen, generic). Bryn intends to present study results at upcoming medical conferences.
Epinephrine autoinjectors are the most widely prescribed treatment in the outpatient setting for anaphylaxis. While effective, autoinjectors have several limitations, including cost, fear of needles and convenience, leading people to avoid carrying the recommended two autoinjectors. This puts patients at greater risk of severe complications during an allergic reaction.
“We are extremely encouraged with the results from our pivotal study comparing the needle-free UTULY nasal spray to the 0.3 mg IM autoinjector. Our findings have given us the confidence to move forward in the regulatory process. We are thrilled to be one step closer to improving the lives of people who live in fear of life-threatening allergic reactions and who are looking for alternatives to costly and cumbersome autoinjectors,” said David Dworaczyk, Ph.D., CEO of Bryn Pharma.
“Completion of this study is a key milestone in the evolution of the treatment for anaphylaxis. Our hope is that the clinical trial results from Bryn’s innovative nasal product will support UTULY as an effective, safe and practical alternative to autoinjectors,” said Melinda Braskett, M.D., Associate Medical Director of the Gores Family Allergy Center at Children’s Hospital Los Angeles, and Bryn Pharma Scientific Advisor.
Anaphylaxis is a serious, life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medication and latex.1 A major difference between anaphylaxis and other allergic reactions is that anaphylaxis typically involves more than one system of the body.2 Estimates of Americans at risk for anaphylaxis range from 3.29 million to 40.9 million.3 Early and fast administration of epinephrine (with quick uptake) using today’s most common method of delivery, the autoinjector (as opposed to a manual syringe which is used in a medical setting under the direct supervision of a doctor), is deemed critical to bringing the anaphylactic reaction under control. Because 30% of patients who develop anaphylaxis will require a second dose of epinephrine to control symptoms, practice parameters recommend that physicians provide patients with two autoinjectors.4
If not treated properly, anaphylaxis can be fatal.1 However, studies have shown that the majority of people at risk for anaphylaxis often do not carry two epinephrine autoinjectors due in part to size and cost of the products, putting patients at greater risk of severe complications during an allergic reaction.5
About Bryn Pharma
Bryn Pharma, established in 2017, is a privately held pharmaceutical company founded by patients for patients. Bryn is focused on positively disrupting the existing market for epinephrine autoinjectors by delivering an accessible, easy-to-use alternative that better meets the needs of patients. Bryn Pharma seeks to provide this growing population at risk for anaphylaxis with A Better Way to be prepared for a life-threatening allergic reaction. For more information visit www.brynpharma.com.
Forward Looking Statements
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits are forward-looking statements. A number of risks and uncertainties, such as risks related to product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the Company’s products to patients, market and physician acceptance of the Company’s products, intellectual property protection and competitive product offerings, could cause actual events to differ from the expectations indicated in these forward-looking statements. You are cautioned not to put any undue reliance on any forward-looking statement. This press release is neither an offer to sell nor a solicitation of an offer to purchase any particular securities. Any such offer or solicitation will be made only pursuant to definitive legal agreements prepared specifically for such purpose. An investment in the Company’s securities entails significant risks and is suitable only for sophisticated investors who can afford a loss of their entire investment; no assurance can be given that investment objectives will be achieved. In considering the performance information contained herein, you should bear in mind that past performance is not necessarily indicative of future results; there can be no assurance that the Company will achieve comparable results or that any projected returns will be met. The Company does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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Rebecca Novak Tibbitt