CORALVILLE, Iowa, March 07, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH) announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) 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.
Similar to KemPharm’s lead product candidate, KP201/APAP, which is currently under Priority Review by the FDA, KP511 utilizes the KemPharm’s Ligand Activated Therapy (LAT) platform technology to create its abuse-deterrent properties at the molecular level. KemPharm believes this proprietary design offers the potential to restrict the release of the active hydromorphone component until the prodrug is metabolized following oral administration. KP511 is designed to be bioequivalent to currently available ER hydromorphone products.
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.”
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its Ligand Activated Therapy (LAT) platform technology. KemPharm utilizes its LAT platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, ADHD and other CNS disorders.
Caution Concerning Forward Looking Statements
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. These forward-looking statements include statements regarding the expected features and characteristics of KP511. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm's financial resources and whether they will be sufficient to meet KemPharm's business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results; the protection and market exclusivity provided by KemPharm's intellectual property; risks related to the drug discovery and the regulatory approval process; the impact of competitive products and technological changes; and the FDA approval process under the Section 505(b)(2) regulatory pathway, including without limitation any timelines for related approval. KemPharm's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm’s business are described in additional detail in KemPharm's Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
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