KemPharm, a clinical-stage specialty pharmaceutical company based in Coralville, has received encouraging news from an early study designed to assess the company's abuse-resistant form of the painkiller hydromorphone.
The company in a press release reported that a clinical study of its investigational prodrug, KP511, demonstrated a statistically significant reduction in peak and overall hydromorphone exposure compared to equivalent doses of hydromorphone hydrochloride (HM), commonly sold as Dilaudid or Palladone. That resulted in meaningfully lower scores in exploratory measures of "Drug Liking," "Feeling High," "Overall Drug Liking" and "Take Drug Again," when compared to HM, the company said.
KemPharm's molecular engineering approach, known as Ligand Activated Therapy, allows it to create prodrugs that metabolize only when exposed to digestive enzymes in the small intestine. That discourages abusers from snorting or injecting the drug, because they will not experience the "high" associated with the powerful opioid.
If further studies confirm that KP511 provides meaningful differences in intranasal abuse potential, the company may seek to develop both immediate-release and extended-release versions of the drug, the company said in a statement. KP511 will undergo more study in the next two years, potentially leading to two New Drug Applications (NDAs) being submitted as early as 2019 with a request for expedited review.
"Based on our estimates, in 2015, the combined ER and IR market for hydromorphone was more than $280 million, with over 3.2 million scripts written in that year," President and CEO Travis Mickle said. "A market this large requires products with effective abuse deterrence."
KemPharm in December also received "Fast Track" designation by the U.S. Food and Drug Administration for its NDA for KP201/IR, an immediate-release, abuse-deterrent prodrug of hydrocodone. The company expects human clinical trials to begin for that prodrug in the first half of this year.