Aquestive Therapeutics AQST-109 on FDA Fast Track

Having the opportunity to have “an orally delivered epinephrine” could be a game changer. Recently Aquestive Therapeutics, Inc. (NASDAQ:AQST), announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AQST-109, “the first and only orally delivered epinephrine-based product candidate for the emergency treatment of allergic reactions, including anaphylaxis”. The FDA Fast Track process is “designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill unmet medical needs.”

Aquestive Therapeutics AQST-109 on FDA Fast Track

FDA and Aquestive Logos

KFA News Team
April 10th, 2022
WARREN, N.J.

Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AQST-109, the first and only orally delivered epinephrine-based product candidate for the emergency treatment of allergic reactions, including anaphylaxis.

“We are focused on continuing to develop and, if approved, bringing this transformative product to patients and caregivers given its potential to significantly improve how they manage anaphylaxis,” said Keith Kendall, Chief Executive Officer of Aquestive. “Fast Track designation is an indication that the FDA recognizes that AQST-109, if approved, fulfills a significant unmet need. An epinephrine oral film like AQST-109 would provide patients with a rescue medication where they need it, when they need it, and in a form they prefer.”

Fast Track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill unmet medical needs. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, eligibility for FDA accelerated approval, and priority review if relevant criteria are met, in addition to a rolling submission of the marketing application.

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A Summer Trip Took a Near-Fatal Turn for Bill Walton

March Madness! This time of year, college basketball dominates the airwaves as well as so many discussions about which team is up, the biggest upset so far and how well your selection bracket is doing in the office pool. One of the all-time college basketball greats was Bill Walton. Walton also went on to earn several awards during his NBA career, despite having several injuries. A career that almost didn’t occur because of a near fatal bee sting in the Summer of 1973.

A summer trip took a near-fatal turn for Bill Walton

Bill Walton portrait
The first overall pick in the 1974 NBA Draft, Bill Walton had a star-crossed career because of injuries. But it nearly never happened at all.

by Phil Watson
Originally published
December 26, 2021

Article excerpt is reprinted with permission from author Phil Watson and posted on sportscasting.com

Bill Walton was one of the greatest college basketball players of all time. Despite a career as an NBA player marred by injuries, he won an NBA MVP, an NBA Finals MVP, and a pair of titles. But an incident between his junior and senior seasons at UCLA nearly ended his pro career before it started.

Walton, 69, remains one of the most colorful personalities in the game. He was the first player in NBA history to win MVP and Sixth Man of the Year honors. James Harden joined him in the exclusive club with his MVP win in 2017–18. Because of recurring foot and ankle problems, Walton’s career remains one of his era’s biggest “what-if” questions.

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‘He started feeling weird’: Wife of Hatboro police officer remembers life together before he was stricken by a bee sting

Ryan Allen is a husband, father, police officer and the tragic victim of a bee sting. That venomous sting set in motion a series of events that now have Ryan residing in hospice care. Here are stories and reflections about Ryan from friends and family who are so proud of him and who love him so very much.

‘He started feeling weird’: Wife of Hatboro police officer remembers life together before he was stricken by a bee sting

Allen family photo
Hatboro police officer Ryan Allen is pictured here with his wife, Whitney Allen, their son, Jackson Allen, and their dog, Louie, at home. Allen is in hospice care after suffering an anaphylactic reaction to a bee sting in October. (Contributed photo)

By ANDREW SCOTT
MAR 11, 2022 

Whitney Allen was pregnant with her second child with Hatboro police officer Ryan Allen last year, looking forward to their life together with the growing family.

Then came Oct. 7.

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CEO Expects Approval and Launch of Intranasal Emergency Epinephrine Spray by Summer 2023

When anyone has an attack of anaphylaxis, we know that epinephrine is a life-saving treatment. We also know that for a lot of people, “fear of the jab” is one of the things that prevents them from using epinephrine; the medication must be administered by intermuscular injection. By the Summer of 2023, according to the CEO of ARS Pharma Richard Lowenthal, a new method to administer epinephrine may help make that fear obsolete.

CEO Expects Approval and Launch of Intranasal Emergency Epinephrine Spray by Summer 2023

ARS-Pharma Research promo pix

By Dave Bloom
2022/03/02

SnackSafely.com has been following the progress of a number of emergency epinephrine auto-injector alternatives over the years. These provide an alternate means of delivering epinephrine in an anaphylactic emergency to the needle used in traditional auto-injectors like EpiPen and prefilled syringes like Symjepi.

Why is this important? Because a delay in administering epinephrine during anaphylaxis results in poorer outcomes, and “fear of the jab” can sometimes lead people to delay administering the drug. The bulkiness of some brands of auto-injectors can also result in people leaving them at home when they should be carrying two doses with them at all times. 

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Oral Immunotherapy Alleviates Peanut Allergy in Some Young Children

Having a life-threatening food allergy is scary for anyone, but when you’re the parent of a young child with one, that fear is a constant. A recent NIH funded clinical study examined the impact of peanut oral immunotherapy to children one to three years old who are highly peanut allergic. The results were positive and provide hope for finding additional methods to desensitize young children to peanut allergies.

Oral Immunotherapy Alleviates Peanut Allergy in Some Young Children

Wesley Burks, MD and Edwin Kim, MD head shots
Wesley Burks, MD, and Edwin Kim, MD

This study, called IMPACT, was co-led by A. Wesley Burks, MD, CEO of UNC Health and dean of the UNC School of Medicine. Edwin Kim, MD, is co-author on the paper and leads peanut allergy research at the UNC School of Medicine.

January 20, 2022

A clinical trial funded by the National Institutes of Health has found that giving peanut oral immunotherapy to highly peanut-allergic children ages 1 to 3 years safely desensitized most of them to peanut and induced remission of peanut allergy in one-fifth of participants.

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