KemPharm (KMPH) Begins FDRR Process to Appeal FDA Complete Response Letter on Apadaz

November 3, 2016 7:39 AM EDT
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KemPharm, Inc. (Nasdaq: KMPH) 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.

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