2020/02/06 -Pre-IND Meeting on AQST-108 Completed -FDA Confirmed AQST-108 To Be Reviewed Under 505(b)(2) -No Additional Clinical Studies Would Be Required Prior to Opening Proposed IND -Pivotal Pharmacokinetic (PK) Clinical Trials Planned To Be Initiated Before Year End 2020
WARREN, N.J., Feb. 06, 2020 (GLOBE NEWSWIRE) — Aquestive Therapeutics (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, announced today that it had a constructive face-to-face pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) for its drug candidate, AQST-108, a “first of its kind” oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis using Aquestive’s proprietary PharmFilm® technologies.
You would think that first responders would always have epinephrine on hand to use in an emergency anaphylaxis situation when every second counts. However that was not the case when Giovanni Cipriano had a severe allergic reaction to peanuts and could not be helped in time by first responders. His mother Georgina made it her life’s mission to pass “Gio’s Law” allowing police officers and firefighters to carry and administer epinephrine, signed into law last December. You can read the full story here.
Bill Signed Allowing Police and Firefighters to Carry and Administer Epinephrine
Edited by Jon Terry January 12th, 2020
In late December, with the 2020 legislative session looming on the horizon, New York State Governor Andrew Cuomo signed "Gio's Law.” This law authorizes police officers and firefighters to carry epinephrine auto-injector (EAI) devices to treat people having dangerous allergic reactions in an emergency.
If defibrillators are required on every airliner, why not an epinephrine auto-injector? Despite resistance from the airline industry, two U.S. Senators and a Representative recently urged the Federal Aviation Administration (FAA) to require that U.S.-based commercial airlines include EAI devices in their onboard emergency medical kits (EMKs). Rep. Khanna of California has been particularly supportive in leading the campaign for greater funding into allergy research and treatment options. She helped secure an increase of $362 million in funding for the National Institute of Allergy and Infectious Disease (NIAID) with a directive to invest in food allergy research, and an additional $10 million for the Peer-Reviewed Medical Research Program (PRMRP) under the Department of Defense.
“This Is A Simple Step That Will Undoubtedly Save Countless Lives.”
It might seem obvious that taking steps to help avoid allergic reactions to peanuts would improve the quality of life for families with someone who has a severe allergy. But it’s nice to know that a scientific study backs this up. Children ages 8-12 participated in the Viaskin Peanut study where they were slowly exposed to their allergen through a patch that releases peanut proteins through the skin and stimulates the immune system. Participants must still practice peanut avoidance, but it will take a lot higher protein exposure to cause the treated patient to react.
Desensitizing therapies are emerging for food allergies and being considered for approval by the FDA. But some in the medical community raise this question: Is desensitization, which is not a cure, enough to improve a food-allergic person’s quality of life?
A new study of families involved in DBV Technologies’ Viaskin Peanut patch therapy clinical trials gives insights into an answer. It found significant overall improvement in quality of life related to gaining greater peanut tolerance on the patch treatment. As well, questionnaires filled out by both children and parents showed quality of life gains in specific areas.
With parents, “the areas where we saw the most impact were the emotional impact, food-related anxiety, and social and dietary limitations,” Dr. Todd Green, DBV’s vice president of medical affairs for North America, told Allergic Living. In the children, aged 8 to 12, “when they were asked questions around avoidance or accidental exposure, that’s where that’s where they reported the most improvement,” he said.