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Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

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Promising data presented at the American Society for Clinical Pharmacology and Therapeutics annual meeting continue to support Utuly, a novel intranasal epinephrine spray for treating anaphylaxis.

, David David Dworaczyk, PhD, CEO, Bryn Pharma, said Utuly exhibited a higher and more prolonged pharmacokinetic (PK) profile, and has now demonstrated similar heart rate and blood pressure effects when compared with an epinephrine autoinjector. 

"We're clearly showing that there is a positive outcome from the heart rate and blood pressure changes that are the same as with the EpiPen, but in addition to that, we do show that the epinephrine blood levels, in fact, do go higher and are sustained longer than with the epi-pen," he stated.

The clinical studies followed methodologies recommended by the US Food and Drug Administration (FDA). Bryn Pharma has been in communication with the agency about the development of Utuly since the preclinical data were presented and positively received by the FDA.

American Academy of Allergy, Asthma & Immunology (AAAAI) 2023 Annual Meeting

 confirmed the go-to-market dose of Utuly.

"We do have a confirmed dose that is as good as, or better than, the EpiPen with a very rapid absorption and a PK profile that would suggest a prolonged exposure to therapeutic levels of epinephrine," he said.

The latest data reflect the congestion study, which compared the results of administering the nasal spray in the same nostril and in each nostril with the impact of a congested model and a non-congested model, as well as with the use of an EpiPen. 

According to the results, the nasal spray was absorbed 60-70% more with nasal congestion, and even with high epinephrine doses, there were no unexpected adverse events. 

Dworaczyk explained that the plasma concentrations of epinephrine were sustained for a longer period of time than with the EpiPen. Although no clinical efficacy studies have been conducted in anaphylaxis, he believes that prolonged exposure to therapeutic levels of epinephrine will result in a significant therapeutic effect.

"It's a very exciting time for the work that we've done," he said.

Grossi G. David Dworaczyk, PhD, Presents Phase 3 Data on Novel Intranasal Epinephrine. HCPLive. February 24, 2023. 

https://www.hcplive.com/view/david-dworaczyk-presents-phase-3-data-novel-intranasal-epinephrine

Data presented at the American Society for Clinical Pharmacology and Therapeutics annual meeting show promise for Utuly, a novel intranasal epinephrine spray for treating anaphylaxis.

David Dworaczyk, PhD, Shares New Data on Nasal Epinephrine for Anaphylaxis

About 80% of all upper respiratory illnesses start in the nose, which is the window to the lungs, Gail Lebovic, MA, MD, said in an interview with 

. As a surgeon, she shared that decontaminating the nose after surgery known known to improve post-op infection rates. 

Lebovic is the founder of the Society of Oncoplastic Surgery, founder and CEO of Silicon Valley Innovations, and the inventor of NasoClenz, a novel intransal antispetic cleansing kit. 

"Our team kind of specializes in identifying niches in clinical medicine that need problem solving and we see this as opening the door to a new market," Lebovic explained. "For nasal hygiene, we all know the products that are out there sprays, rinses, etc, for the sinuses, but no one has really addressed the anterior portion of the nose, the nostril where the skin and the hair inside is contaminated."

Data from a study that examined the efficacy of NasoClenz were presented by lead investigator 

, MD, AHK Primary and Preventive Medicine, at the 

. Results showed that 84% of participants reported a significant decrease in their allergy symptoms.

"Not only did they report a decrease in their nasal symptoms," she said, "but many of them have upper respiratory issues as well, like cough, and at least 70% or more of those patients also reported an improvement in their chronic cough."

However, patients with allergy or respiratory issues aren't the only population who might benefit from intranasal cleansing. The practice of oral hygiene has improved health issues from gum disease to cardiac disease, and Lebovic believes nasal hygiene can have a positive impact as well.

"I thought it'd be a great idea for our team to develop a comfortable, convenient way of cleaning the nose that could be used on a daily basis," she said. "It can be used when you're traveling, for allergy sufferers, for people who use CPAP–clearly there are patient populations who need it more than others–but truly, we wanted to develop a product that was good for everyone."

Practicing oral hygiene improves health issues from gum disease to cardiac disease, and Lebovic believes nasal hygiene can have that impact as well.

Conference

Gail Lebovic, MD: the Nose is the Window to the Lungs

With his practice located in central CA, Arman Kalamkarian, MD, of AHK Primary and Preventive Medicine, is confronted with "an exorbitant amount" of patients that suffer from 

. His recent study on a novel intranasal cleanse showed that over 80% of the 20 patients with chronic allergy symptoms reported significant improvement in their symptoms after 2 weeks of intranasal cleansing with NasoClenz.

“NasoClenz is a novel approach because it cleans the nostrils, whereas other sinus cleansing products usually are targeting the sinus, bypassing the nostrils, and the irrigation methods are not targeting the same anatomical location,” he explained. “And so, being able to treat the nostrils and clean the nostrils may be an adjuvant therapy to sinus irrigation and other products like it on the market.”

The cleansing kit included an applicator and gel containing benzalkonium chloride which patients applied to their nostrils twice daily for 2 weeks. To examine the effectiveness of the practice, Kalamkarian and investigators administered a modified RCAT survey for the 20 participants and obtained nasal cultures from 9 of them before and after the test period.

"The anticipation would be–wash your hands, brush your teeth, clean your nose–and allow that process to help the patients who suffer from allergy symptoms," lead investigator Dr. Arman Kalmakarian says.

Novel Intranasal Cleansing Kit Improves Allergy Symptoms in Over 80% of Patients

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