KemPharm files NDA at FDA for KP 201/APAP to treat acute pain.

KemPharm, Inc. announced that it has submitted a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for KP201/APAP to the FDA and has requested priority review. If priority review is granted, the FDA typically takes action within six months from the date the NDA is accepted for review, potentially allowing for approval as early as Q3 2016.

KP201/APAP is an immediate release (IR) combination of KemPharm�s prodrug of hydrocodone, KP201, and acetaminophen (APAP), and is being developed for the treatment of acute pain. KemPharm has requested that KP201/APAP be designated as a Schedule III controlled substance by the Drug Enforcement Administration based on what KemPharm believes is the reduced potential for abuse and the potential safety features attributable to lower exposure levels to hydrocodone for KP201/APAP as compared to other hydrocodone/APAP products, which have been designated as Schedule II. In addition, based on the results of the human abuse liability program completed for KP201/APAP, as well as feedback from the FDA, KemPharm believes there may be support for Category 1, Category 2 and potentially Category 3 abuse-deterrent language in the KP201/APAP product label, if approved by the FDA.