Richard Lowenthal
👤 PersonAppearances Over Time
Podcast Appearances
Yes, certainly.
Thank you.
I've been in the industry about little over 30 years, started my career at the food and drug administration after graduate school.
and then moved into industry after about five years at the FDA.
And during my time in industry, I worked on a number of different programs, including some that were nasal spray products and including some experience with epinephrine.
More recently, I was one of the people that helped develop Narcan nasal spray and, in fact, was the lead representative to the Food and Drug Administration and got Narcan approved.
Also, some other emergency use nasal sprays, like where my clinical research organization Pacific link did all of the clinical work and regulatory work for that program.
And we got that approved for a company called, which is here in San Diego as well.
And then we worked on a number of others, including Opvi, which is the second opioid antagonist, meaning for opioid overdose approved by the FDA that's a nasal spray.
And then some others like Tesamra and other nasal products that we worked on.
So based on that experience and working with the company that owned this absorption enhancing technology we're using, Intravail,
The company is Aegis.
We made an agreement with Aegis to license the technology for an attempt to see if it would work with epinephrine.
And we did that basically as a small company.
We started ARS based on that.
And initially we are self-funded.
And it was fairly high risk at the beginning because while Intravail works very well with some other drugs that are on the market, a few of them that are on the market now, all those drugs get absorbed intranasally.
But with epinephrine, there was literally zero absorption in an aqueous solution intranasally.
So you couldn't get absorption unless you used solvents and things, but only at very, very high doses, which could be dangerous because they're above the lethal level of epinephrine.
So, it was a little bit of a high risk, but it ended up working very well that in our 1st pilot studies in Australia, we showed that that with the interval formulation that that epinephrine could be very rapidly absorbed even faster than injection with a needle and syringe.