Monday, May 9, 2022

Aquestive advances oral epinephrine plan after clearing phase 1

Aquestive Therapeutics has unveiled a second-generation epinephrine prodrug designed to address the limitations of its lead oral sublingual film. The candidates are designed to provide an alternative to the injectable formulations currently used to treat anaphylaxis.

As Aquestive sees it, epinephrine auto-injectors such as EpiPen suffer from multiple problems. Not all patients at risk of serious allergic reactions carry in-date autoinjectors with them, and many people are unsure how to properly use the devices. Unintentional injections are another problem and cause of adverse events.

New Jersey-based Aquestive is using sublingual film and prodrug technology to provide patients with another option. The goal is to overcome vasoconstriction to provide strong, consistent absorption and the rapid relief patients need during anaphylaxis. 

Aquestive recently completed a phase 1 trial in 28 healthy volunteers to assess whether its lead anaphylaxis candidate AQST-108 meets that goal. The study, coupled with an earlier trial, showed recipients quickly absorbed AQST-108, but the conversion of the prodrug into epinephrine was slower than desired. 

Having generated the data, Aquestive plans to meet with the FDA in the second half of the year to discuss the next steps for AQST-108. Aquestive is also looking beyond AQST-108 to a next-generation product designed to minimize conversion time. 

“We have taken the learnings from the AQST-108 studies regarding absorption and conversion and have applied them to the development of our second generation prodrug, AQST-109. We plan to commence a phase 1 PK trial with AQST-109 and anticipate a topline data readout in the second half of 2021,” Dan Barber, chief operating officer of Aquestive, said in a statement.

Source link

Latest Articles

Widely used chemical linked to 1,00,000 US deaths per year: Study

NEW YORK: Daily exposure to phthalates, a group of chemicals used in everything from plastic containers to makeup, may lead to approximately 100,000 deaths...

Foods to Reduce Inflammation and Strengthen the Immune System

Did you know that you can greatly reduce inflammation and boost your immune system by simply incorporating more anti-inflammatory foods and beverages into your...

Personal Selling

INTRODUCTION Early sellers and traders were not held in high esteem. The Roman word for salesman meant ‘Cheater’ and...

Building Muscle on a Vegan Diet

There are a lot of  misconceptions surrounding veganism. The notion that those who practice it are lacking in protein and therefore muscles is the...

Electrodes in brain new hope for severe cases of epilepsy

Neurosurgeons at All India Institute of Medical Sciences have devised a new technique for operating on children suffering from a severe form of epilepsy...