KemPharm Files IND for KP511, an Investigational Prodrug of Hydromorphone

KemPharm, Inc. (NASDAQ:KMPH) announced that it has filed an Investigational New Drug (IND) application with the US Food and Drug Administration requesting clearance to begin human clinical trials of KP511, KemPharm’s prodrug of hydromorphone. KemPharm plans to develop KP511 as an abuse-deterrent, ER medication for the treatment of moderate to severe pain.

According to the news:

As described in the IND application, KemPharm plans to conduct a clinical program for KP511 that will assess the product’s tamper and extraction resistance, intranasal and intravenous abuse potential, as well as the potential to limit oral abuse and/or overdose.  Additionally, KemPharm intends to investigate the potential that KP511 may improve or reduce opioid-induced constipation (OIC), a common side effect of opioid therapy.

Travis Mickle, Ph.D., President and Chief Executive Officer at KemPharm, said:

Having successfully advanced KP201/APAP through the clinic and into regulatory review, we are very excited to have the opportunity to initiate clinical development of KP511.  Based on the preclinical data we have collected to date, we believe KP511 may have inherent safety and abuse-deterrent properties that could provide important benefits to patients, prescribers and society.  We welcome the opportunity to work with the FDA on this IND application with the hope of initiating the KP511 clinical program in 2016.

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