Dr. Travis Mickle, PhD, President and CEO of KemPharm, Inc., discusses the FDA approval of their new ADHD drug AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsule) for ages 6 to adult, a once-a-day pill with rapid onset of 30 mins and lasts 13 hrs without the side effects associated with the current standard of care.
Welcome to health professional radio i’m your host neil howard thank you so much for joining us again i’m going to be speaking with dr travis mickel he’s president and ceo of chem farm he’s joining us on the program to talk about the fda approval of their new adhd drug welcome to health professional radio dr travis michael thank you very much neil give us a little
Bit of insight into who you are and what it is that you do and then let’s talk a bit about what chem farm has been up to uh sure uh i have a phd in medicinal chemistry and earned that uh way back when from the university of iowa i was very fortunate enough after that experience to to go to an organization known as new river pharmaceuticals that that organization
Not unlike kim farm to some degree rose up very quickly and i was a big part of the invention discovery and development of what is a multi-billion dollar product for takeda known as the vivance which also start treats adhd and from there you know started kim farm and uh have been a part of that ever since and uh and happy to be another part of treating adhd as
It’s personal to me i have two young children with it and myself as well so i live with it every day now is chem farm dedicated to adhd drug research or are there other products in your pipeline as well we do have other products in our pipeline um as i mentioned you know adhd has been a passion of mine um something that i feel has a tremendous need that needs to
Be addressed but at the same time we have worked in uh working with the opioid epidemic and trying to uh better that we have a product that’s already been approved and we do focus generally on central nervous system diseases like schizophrenia adhd pain those sort of things but you know the the company itself our pipeline is fairly agnostic as to what uh what
Types of products we could work on and benefit the fda just announced the approval of a new treatment for adhd from kim farm tell us the name of this drug how does it work uh the product is known as the staris you’re right it just just got approved so it’s not officially out yet but it will be shortly the product itself is fairly old as far as the basis goes it’s
Based on the active ingredient known as methylphenidate methylcinnadate better known as ritalin or concerta has been around really since the 1960s to treat adhd in one form or another and what we’ve done is we’ve taken that and we’ve we’ve tried to improve that making it something that can start earlier in the day last longer throughout the day and give a very
Consistent and predictable profile to how it performs for whether it’s for children or for adults or whoever’s taking that product okay you mentioned taking it earlier in the day longer lasting children what would you say are some of the biggest challenges facing patients with adhd and their families and talk a little bit about some of the challenges that maybe
The doctors managing their treatment might face as well this is a great question i live with this literally every morning but we received a lot of feedback you know we did we do market research to find out what physicians are looking for uh what what patients uh you know feedback has been about various products and what we heard is that especially for children
You know having something that would work quickly but yet still provide uh efficacy and effect uh well out past you know dinner time so that you’re you know getting into the bedtime routine uh with with some sort of focus available for those patients um really was was the key uh designer around the product and you know say you take your product at 7 00 am you
Know take your uh medicine then you know it starts to work at about 7 30 and it’s still lasting about 8 o’clock but it still wears off for bedtime and still lets everything happen and we heard that that physicians felt that you know a product that could achieve that that could actually demonstrate that would be of value to their patients because the number one
Thing they get is well my product doesn’t work soon enough and then they switch which and the problem is well it doesn’t last long they’re stuck between those two um bookends of therapeutic uh the products that are available right now is this product effective in adults as well as children uh the product itself is indicated for for patients that with adhd six
And ages six and up and so with this particular product methylcinnadate based products that is uh we see that this is efficacious in in the vast majority of patients if not all patients with adhd and so the fda and of course medical science knows that they look while we didn’t do a formal study it will work in adults that suffer from adhd just as well as it will
For children and it really depends on those patients and what they need you know whether it’s earlier effect later day uh effect or you know however they need to maintain their symptom control you know this product will give them that option uh irregardless of age now i do understand that it’s not yet available but what are your plans for uh commercializing uh
Stars when could it possibly be available for patients uh we actually partnered our product we are really focused on the discovery and development of novel pro drugs here at kim farm and so we partner our approved assets out to other companies who are better suited to commercialize those products um our partner in this case is aquarium incorporated and they
They have they have indicated to us and we have been able to say uh it should be available um in the second half of this year so right around the corner certainly not a long time let’s talk a little bit about pro drugs i understand that uh chem farm is working uh to develop pro drugs what first of all is a pro drug it’s actually a fairly straightforward type
Of technology a pro drug is simply uh in our case anyway we take an existing approved therapy we modify it chemically once that modification is prepared we have a new molecule and that new molecule can go and and um you know benefit the patient in numerous different ways it’s what i said about onset and duration uh it could be less abusable it could be safer
With lower side effects as the list goes on and on but you know once you take it as directed it it will give back the same active ingredient so the same drug you start with in this this particular case for startups it’s methylphenidate and that will actually now impart the same efficacy so you know you’re starting with a great product and you’re making it better
And we see that as a win-win uh for patients with wherever we decide to uh spend our efforts give us a website where our listeners can go and get some more information about chem farm and uh about astairis as well uh kimbob is pretty easy www.kmkempharm.com uh it’s all it’s all one word and it is start with a k instead of a ch uh as far as the stars goes i don’t
Believe there’s a formal website yet that’s established but that’s spelled a z s t s-t-a-r-y-s and once that’s available i believe the stars.com uh would be up and going uh there may be a placeholder there for now well travis i appreciate you joining us share this information with us here on health professional radio thank you very much yeah thank you you’ve been
Listening to health professional radio i’m your host neil howard in conversation with dr travis michael president and ceo of chem farm incorporated audio copies of this program are available at hpr.f and healthprofessionalradio.com.edu you can also subscribe to the podcast on itunes listen in download to soundcloud and be sure to subscribe to our youtube channel
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Transcribed from video
KemPharm – New ADHD Drug By Health Professional Radio
