Travis Mickle’s work developing better drugs for attention deficit hyperactivity disorder is deeply personal – he has ADHD and so do his children.
After receiving his PhD in organic chemistry from the University of Iowa, Mickle went on to work at New River Pharmaceuticals, where he developed the leading treatment for ADHD, Vyvanse. Now he serves as the CEO of KemPharm (NSDQ:KMPH), where he leverages his scientific-know and his own experiences with ADHD in an attempt to create improved versions of already-approved drugs.
The compounds are called prodrugs – a drug that has been chemically modified to boost some aspect of its pharmacokinetics. KemPharm scientists chemically attach ligands, an inert group like a sugar or a protein, to the parent drug. The ligand is later removed by the body, leaving the parent drug to deliver its desired effect.
“The prodrug itself can change pharmacokinetics. It can change metabolism, it can change absorption,” Mickle told Drug Delivery Business News. “You can get different side effect profiles, you can target organs, there’s just a laundry list of things you can do with a prodrug.”
From his experience with ADHD medications, Mickle knew that one of the challenges facing the community is that ADHD drugs don’t start working for about an hour and a half after you take them. Then, the effects last for 12 to 13 hours before wearing off at the end of the day.
The company also knew that kids tend to use methylphenidate products because they are milder, with fewer side effects, while adults often turn towards the more-potent Vyvanse, an amphetamine product.
“So what was unmet was that need for the folks that really only can take the methylphenidate products – the ones that may prefer methylphenidate because of the lower side effects of the younger age,” Mickle said.
Mickle set off to develop a prodrug of methylphenidate that would maintain the mild side effects of the traditional version, but would also feature a longer duration of effect and a faster onset.
In its latest study of KP415, the company’s co-lead ADHD product candidate, KemPharm found that the product begins working in the first 30 minutes following administration.
“That can really allow for benefits in the early morning, which from my own parenting and from a lot of market research, we know that’s an unmet need in this space,” Mickle said.
The company also reported that its KP415 sustained a duration comparable to Concerta, a comparative product, after 12 hours.
KemPharm doesn’t just work on ADHD prodrugs. It has also spent years developing abuse-deterrent opioids for the treatment of pain. But there have been challenges, according to Mickle.
Last year, the FDA ruled that KemPharm’s Apadaz opioid pain drug could not be labeled as abuse-deterrent, concluding that it didn’t have the evidence to support the claim. The company has since responded with an appeal and an amended NDA submission, which the FDA is slated to review by February of next year.
Apadaz is a prodrug of hydrocodone and benzoic acid combined with acetaminophen. It is activated by enzymes in the intestinal tract, meaning people can’t get high by snorting, injecting or smoking it.
Mickle told Drug Delivery Business News that the path to market for these products is still very murky, despite an ongoing opioid epidemic and a public that desperately needs new options for pain medications.
“There has been trouble, including with KemPharm, with people and regulatory issues, where it’s not clear what the expectations are,” he explained. “The insurers and payers just don’t feel that this is their problem, so they’re not reimbursing. Physicians don’t understand how they can help, so there is a disconnect between those that really could benefit the most from this, which is society, and those that end up paying or prescribing the products.”
It’s been a long road for KemPharm and for Mickle, who maintains that if he had known in 2006 when he helped start the company what he knows now, he may not have done it.
But the company is gearing up for a busy year ahead – KemPharm is still working to get the abuse-deterrent labeling for its opioid product and it hopes to submit an NDA for KP415 by next year. It is also working on an adult version of its ADHD prodrug, KP484.
The company is also actively looking for ways to collaborate with its technology, Mickle said.
As he seeks to expand the company’s prodrug platform, Mickle points to what he thinks KemPharm can bring to a partnership – strong science and a deep knowledge of the field.
“I think that’s what really makes KemPharm different, because there is a lot of science here, a lot of practical knowledge, but there’s a lot of art to this as well,” he said. “Knowing what may or may not work can really expedite the process and we’ve just done so many, we’ve made so many different candidates and tested them. There’s a collective knowledge that doesn’t really exist outside of KemPharm.”