KemPharm Receives NDA User Fee Waiver from FDA

KemPharm, Inc. (NASDAQ:KMPH) announced that the U.S. Food and Drug Administration (FDA) has granted a fee waiver and has refunded the full user fee amount of $2,374,200 for its New Drug Application (NDA) filing for KP201/APAP, the Company’s investigational immediate release combination of its hydrocodone prodrug, KP201 (benzhydrocodone hydrochloride), and acetaminophen (APAP), which is currently under priority review by the FDA.
According to the news:

The fee waiver, which KemPharm requested in accordance with section 736(d)(1)(E) of the Federal Food, Drug and Cosmetic Act, is granted to a small business, as defined by the Small Business Administration, for the first human drug application submitted to the FDA for review.

Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm, commented:

We are pleased to receive this NDA fee waiver for KP201/APAP and look forward to continuing to work with the FDA through the review process.  We believe that prodrugs developed using our Ligand-Activated Therapy technology may demonstrate properties that are aligned with the advice of regulatory, physician and patient organizations advocating for responsible measures for managing pain and prescribing opioids, including recommendations that opioid therapy for chronic pain begin with the introduction of immediate-release opioids as a means to reduce the risks associated with long-acting or extended-release opioids.

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