CORALVILLE, Iowa, Nov. 03, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced it has appealed the Food and Drug Administration's (FDA) Complete Response Letter (CRL) for Apadaz™ (benzhydrocodone and acetaminophen) through the initiation of the Formal Dispute Resolution Request (FDRR) process. Apadaz™ is KemPharm’s investigational product candidate that is intended to provide short-term management of acute pain in a product with abuse-deterrent attributes.
The CRL was received in response to the KemPharm submission of a new drug application (NDA) for Apadaz last year. KemPharm completed an end-of-review meeting in August 2016 in which the FDA provided the Company with a more complete understanding of its assessment of the NDA.
"KemPharm believes that it has satisfied the statutory requirements for approval of Apadaz as a bioequivalent immediate-release opioid /acetaminophen product suitable for the management of acute pain, and one for which truthful and non-misleading information about abuse deterrence can be included in the labeling," stated Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. "In the clinical development program, Apadaz did not meet FDA preferred clinically meaningful endpoints including Drug Liking Emax and Take Drug Again scores, but we believe it did demonstrate statistically significant differences, compared to an approved non-abuse-deterrent formulation, on measures of abuse deterrence. We believe those measures are relevant for the intranasal route of abuse and, importantly, we believe these differences reflect a clinically meaningful public health benefit that physicians and patients deserve to have acknowledged in the product labeling for appropriate medical treatment decision-making.”
“We believe that intranasal abuse is a relevant route of prescription drug misuse for hydrocodone combination products and that providing truthful and complete information regarding the outcome of abuse deterrence studies in product labeling is essential to ensuring prescribers with the complete information needed to make informed prescribing decisions,” Mickle continued. “The FDRR process may be short or could include several steps that have the possibility of taking up to 12 months. In a FDRR process, the FDA typically requests that companies not make interim updates on the ongoing review and as such, we intend to only announce a final determination once the process has been completed.”
About the FDA's Formal Dispute Resolution Process
The appeal was submitted in accordance with the FDRR process that exists within FDA's Center for Drug Evaluation and Research (CDER). FDA regulations provide a mechanism for those seeking regulatory approval of a drug product pursuant to an NDA to obtain formal review of any Agency decision by raising the matter with the supervisor of the employee who made the decision. The process exists to encourage open, prompt discussion of scientific (including medical) disputes and procedural (including administrative) disputes that arise during the drug development, NDA review, and post-marketing oversight processes.
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, attention deficit hyperactivity disorder and other central nervous system 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 potential outcome of the FDRR process and any timeline for the resolution thereof. 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, and KemPharm’s other 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.
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
Daniel L. Cohen
Executive VP, Government and Public Relations