We've written before about KemPharm's work with Monosol Rx on abuse-resistant ADHD drugs. Now, there's news about KemPharm's other major abuse-resistant drug in the works: KP201, which releases pain-relieving hydrocodone into the bloodstream. The company announced positive results from a Phase I clinical trial.
A company spokesman, in an e-mail to FierceDrugDelivery, called KP201 "a potential leap forward in pain therapy as it leverages KemPharm's proprietary Ligand Activated Therapy prodrug technology to produce a new chemical entity that has the potential to improve both abuse resistance and the reduction/elimination of opioid-induced constipation."
The company says the Phase I data confirmed that KP201 releases hydrocodone into the bloodstream at amounts equivalent to Norco, a pain medication composed of acetaminophen and hydrocodone. Also, the company said, there was no detectable residual KP201 in the body.
"Our findings from this first clinical trial of KP201 are as good as we could have hoped," KemPharm VP of Research Sven Guenther said in a news release. The next step is an NDA filing in the next 18 to 24 months.
- read the KemPharm release