KemPharm ($KMPH), at work on an abuse-deterrent formulation of hydrocodone, said its lead drug performed well in a study designed to determine how easily the pill can be ground up and snorted.
In a so-called human abuse liability (HAL) trial, volunteers who abused KemPharm's KP201 got 36% less exposure to the active ingredient than those who snorted Vicodin, and patient-reported "drug liking" was significantly lower with KP201, the company said.
The positive results follow KemPharm's success in a previous oral HAL trial, and the company is now working through a second intranasal study with data expected this quarter. If all goes according to plan, KemPharm plans to submit its hydrocodone treatment to the FDA before the end of the year.
KemPharm's shares rose about 18% on the announcement, echoing the investor optimism that helped the Iowa company pull off a $56 million IPO in April.
"We believe this study is the first direct, head-to-head comparison of an API for immediate-release prescription opioid products to demonstrate such a meaningful difference in opioid exposure, highlighting the inherent benefits of our prodrug technology," KemPharm CEO Travis Mickle said in a statement.
Beyond KP201, KemPharm is working up early-stage therapies derived from hydromorphone, oxycodone and morphine. Outside of the pain field, the company is developing preclinical drugs with the same active ingredients as the ADHD treatment Concerta and psychotropic Seroquel.
- read the statement