KemPharm Reports Positive Data From Oral Human Abuse Liability Clinical Trial

(RTTNews) - KemPharm, Inc. (KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, announced positive data from its oral human abuse liability clinical trial of KP201/APAP, the company's most advanced product candidate.

KP201/APAP is an immediate release combination of KP201, the company's prodrug of hydrocodone, and acetaminophen or APAP, which is being developed to provide clinicians and patients a novel abuse-deterrent immediate release prodrug of hydrocodone/APAP, the most commonly prescribed opioid in the United States.

The KP201.A01 oral human abuse liability trial was designed to measure hydrocodone exposure, drug likability and the safety of KP201/APAP, as compared to Norco, when taken orally at 4, 8 and 12 tablet dosages, each of which are much greater than the recommended amount.

Highlights of the trial results included lower exposure to hydrocodone at the highest dose levels for the trial, as well as lower incidence of hypoxia across the same dosage levels, in each case compared to hydrocodone reference drug, suggesting the potential for improved safety. As expected, liking data was similar at each equivalent dose level, the company noted.

As announced earlier, KemPharm's management held a pre-New Drug Application or NDA meeting with the FDA for KP201/APAP on May 20, 2015. Based upon the results of this meeting, KemPharm intends to submit an NDA under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for KP201/APAP to the U.S. Food and Drug Administration in the second half of 2015.

According to the company, the KP201.A01 trial is part of a broader human abuse liability program designed by KemPharm to assess key abuse-deterrence criteria as specified by the FDA.  Additional components of this program include three nonclinical studies to evaluate the tamper resistance of KP201/APAP and two intranasal human abuse liability clinical trials.

One of the intranasal studies is designed to assess the relative pharmacokinetics and drug likability of KP201/APAP compared to Norco. In the second intranasal trial, the amount of hydrocodone released from the active pharmaceutical ingredient, KP201, is being measured when the API is snorted alone, as compared to hydrocodone bitartrate. Results from these studies are expected in the third quarter of 2015.